Prostate cancer with kidney failure: is surgery, focal therapy or radiation the right choice?

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A patient guide by Dr Jo Schoeman

A diagnosis of prostate cancer is unsettling. Having chronic kidney disease or needing dialysis can make treatment decisions feel even harder. The reassuring point is that kidney failure does not automatically rule out treatment. The best choice depends on the cancer, the degree of kidney impairment, other medical conditions and, crucially, whether a kidney transplant is planned.

What does Gleason 3+4 mean?

Gleason 3+4=7 is Grade Group 2 prostate cancer. Most of the sampled tumour has pattern 3, with a smaller component of pattern 4. It is generally less concerning than Gleason 4+3=7, but “3+4” alone cannot tell us whether immediate treatment is needed.

I would review the PSA and PSA density, examination, MRI findings, number and length of positive biopsy cores, percentage of pattern 4, any cribriform or intraductal cancer, and whether disease is confined to the prostate. Kidney function, dialysis schedule, life expectancy and transplant eligibility are considered alongside these findings. Some men have favourable intermediate-risk cancer; others have features that make definitive treatment more appropriate. Staging scans are selected according to overall risk rather than biopsy grade alone. [1,2]

Could active surveillance be reasonable?

Yes, for selected men with small-volume, favourable Grade Group 2 cancer. Surveillance means scheduled PSA tests, clinical review, MRI where useful and repeat biopsy when indicated. It keeps treatment available if the cancer changes. It is a particularly meaningful option when another serious illness makes the harms of immediate treatment more likely to outweigh its benefit. It does, however, require a patient who can attend follow-up and accepts a small increased risk of progression compared with immediate treatment. [1,2]

If kidney disease or other illnesses substantially limit life expectancy, watchful waiting may be more appropriate: care focuses on symptoms rather than routine testing intended to trigger curative treatment. This is a separate decision from active surveillance. [1]

Can radical prostatectomy or robotic surgery be performed?

Often, yes. Chronic kidney disease and dialysis are not automatic contraindications to radical prostatectomy. Robotic assisted surgery may offer less blood loss and a shorter hospital stay than open surgery in selected patients, but it still involves general anaesthesia, abdominal insufflation and a head-down operating position. Advanced kidney disease increases the importance of planning for bleeding, infection, fluid and electrolyte balance, medication dosing and postoperative kidney injury. Population studies find higher complication rates in patients with chronic kidney disease, particularly advanced disease; individual risk varies considerably. [3,4]

Before an operation I would coordinate with the nephrologist, anaesthetist and, where relevant, dialysis team. We would assess cardiovascular health, haemoglobin, potassium, anticoagulants, residual kidney function and the timing of dialysis. Surgery also carries the usual risks of urinary leakage or incontinence, erectile dysfunction, infertility, blood clots and possible need for further cancer treatment. Whether a robotic approach is feasible depends on the patient and the surgical team; it is not automatically a safer choice for every person with kidney failure. [1,3,4]

Is focal therapy a better option?

Not simply because the kidneys are failing. Focal therapy treats the visible cancer-bearing portion of the prostate, using a technique such as focused ultrasound, cryotherapy or another ablative method. It may appeal to men hoping to reduce urinary or sexual side effects, but the cancer can be present elsewhere in the gland, and longer-term cancer control is less certain than for established whole-gland treatments. Further MRI, biopsies and sometimes repeat treatment are necessary.

The AUA/ASTRO guideline notes a lack of high-quality comparisons with surgery, radiation and surveillance. European guidance restricts focal treatment to settings with careful prospective follow-up, such as a trial or registry. Kidney disease alone does not establish that focal treatment is preferable. In a suitable patient it can be discussed with a specialist who explains uncertainty, access, costs and a clear follow-up plan. [1,2]

Is radiotherapy an option?

Yes. External beam radiotherapy avoids major surgery and usually does not expose the kidneys directly when treating a prostate confined to the pelvis. Options include moderately shortened courses and, for selected men, more condensed schedules or brachytherapy. The radiation oncologist will tailor treatment to the cancer and urinary function. Depending on whether the disease is favourable or unfavourable intermediate risk, a course of androgen deprivation therapy (ADT) may also be advised; ADT has its own effects on energy, muscle, bone and metabolic health. [1,2]

Radiotherapy may cause temporary urinary frequency, burning or bowel upset; longer-term urinary, bowel or erectile effects are also possible. Existing urinary obstruction and kidney transplant anatomy can change planning. In a transplant recipient, the graft and ureter may sit in the pelvis, so radiation dose constraints require particular attention. Dialysis, by itself, does not make prostate radiation impossible. [1,2]

What if a kidney transplant is planned?

This is a central part of the discussion. A transplant team may need to know whether the cancer is under surveillance or has been treated, its estimated risk of progression and the proposed follow-up. The presence of prostate cancer does not automatically mean that transplantation must wait for a fixed number of years; transplant eligibility is individual and should be discussed directly with the transplant team. A transplanted kidney in the pelvis also affects the planning of later pelvic surgery or radiotherapy. [5]

How do we decide?

Option When it may fit Main trade-off
Active surveillance Low-volume, favourable Grade Group 2 disease Regular testing and a possibility of later treatment
Robotic radical prostatectomy Fit patient seeking definitive local treatment Anaesthetic and surgical risks, with continence and erectile side effects
Radiotherapy Patient seeking definitive treatment without prostate removal Urinary, bowel and sexual effects; ADT may be needed
Focal therapy Carefully selected patient after discussion of uncertainty Less established long-term cancer control and ongoing biopsies
Watchful waiting Limited life expectancy or major competing health risks Treats symptoms if they arise rather than aiming for cure

There is no universal winner between robotic surgery and radiation for Gleason 3+4 cancer with kidney failure. A multidisciplinary discussion involving urology, radiation oncology, nephrology and the transplant team, if applicable, helps align cancer control with kidney health and the patient’s priorities.

This article offers general information and cannot determine treatment for an individual patient. Decisions require review of the pathology, imaging, kidney function and overall health.

References

  1. European Association of Urology. EAU Guidelines on Prostate Cancer: Treatment. Accessed September 2026.
  2. American Urological Association and American Society for Radiation Oncology. Clinically Localized Prostate Cancer Guideline. 2022.
  3. Post-surgical outcomes of patients with chronic kidney disease and end stage renal disease undergoing radical prostatectomy: 10-year results from the US National Inpatient Sample. 2019.
  4. The Effect of Chronic Kidney Disease on Adverse In-Hospital Outcomes at Radical Prostatectomy. 2025.
  5. Kidney Disease: Improving Global Outcomes. KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. 2020.

Prostate Artery Embolisation: Who May Benefit, Important Caveats, and Can It Be Done After Radiotherapy?

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Lower urinary tract symptoms: poor flow, hesitancy, incomplete emptying, frequency, urgency and nocturia, are common as men age. When benign enlargement of the prostate (BPH) is genuinely responsible, treatment may include lifestyle measures, medication, minimally invasive procedures or surgery. Prostate artery embolisation (PAE) is one option that may be considered for appropriately assessed patients.

PAE is not simply a “smaller TURP”. It works differently, is performed by an experienced interventional radiologist, and has a different balance of benefits, limitations and risks. The most important question is not whether the prostate looks large, but whether prostatic obstruction is actually causing the patient’s symptoms.

What is prostate artery embolisation?

PAE is a minimally invasive, image-guided procedure. A small catheter is introduced through an artery, usually at the wrist or groin, and guided into the arteries supplying the prostate. Tiny permanent particles or, in selected expert practice, a liquid embolic agent are delivered to reduce blood flow to the hyperplastic prostate tissue. This causes controlled ischaemia, gradual shrinkage of the transition zone and reduced compression of the urethra.

The procedure can often be performed without a general anaesthetic and does not require instruments to pass through the urethra. Improvement, when it occurs, is usually progressive rather than immediate and may take several weeks or months. Results vary, and some men obtain little benefit or require another treatment.

Regulatory note for Australian readers: The TGA regulates therapeutic goods, including medicines and medical devices; it does not “approve” or endorse a medical procedure or an individual health service. References to PAE in this article should not be interpreted as TGA endorsement. Any embolic agent, catheter or other medical device used must be lawfully supplied in Australia and used in accordance with its applicable regulatory status, intended purpose and clinical governance requirements.

Important Wesley Hospital research

Associate Professor Nicholas Brown, an interventional radiologist affiliated with The University of Queensland and I-MED Radiology at The Wesley Hospital, led the following Australian studies of PAE.

The P-EASY ADVANCE randomised controlled trial, published in BJU International in 2024, compared PAE with combined tamsulosin and dutasteride therapy in 39 treatment-naïve men with enlarged prostates, moderate-to-severe symptoms and obstructed or equivocal urodynamic studies. At follow-up, 63% of men treated with PAE were urodynamically unobstructed, compared with 28% receiving medication. Within this study population and follow-up period, the PAE group had greater improvements in prostate volume, urinary flow, incomplete emptying, overall symptom score and quality of life. The trial was small, the estimates should not be generalised to every patient, and larger comparative trials with longer follow-up are required.

The follow-up P-EASY PLUS study, published in BJU International in 2025, assessed 105 men at a mean of 18 months. Mean prostate volume fell by 30.6%, total symptom scores improved by 55%, quality-of-life scores improved by 65.9%, and maximum urinary flow increased by 5 mL/second. Among the 57 men who completed paired urodynamic testing, the proportion classified as obstructed fell from 66.7% to 29.8%. No major procedural complication or new urinary incontinence was reported in this cohort; new retrograde ejaculation occurred in 2%. These are group-level study outcomes and do not guarantee an individual result. The authors noted that longer-term comparative research is required.

The P-EASY ADVANCE publication received the BJUI Global Prize for 2026. This statement describes the publication award only; it is not a patient-outcome claim, regulatory endorsement or guarantee of treatment effectiveness.

Author disclosure: I, Dr Joseph Schoeman, was a co-author of both Wesley Hospital studies. I performed some of the urodynamic studies for this article. Readers should take this relationship into account when considering the discussion. The results are reported with their limitations and placed alongside independent guidelines, randomised trials and systematic reviews. No patient testimonial or individual outcome has been used in this article.

Who may be a good candidate?

PAE may be considered when a man has:

  • bothersome moderate-to-severe urinary symptoms attributable to benign prostatic obstruction;
  • an enlarged prostate, particularly a moderately large or very large gland;
  • inadequate relief, unacceptable adverse effects or a preference not to take long-term medication;
  • a wish to avoid transurethral or more invasive surgery;
  • increased anaesthetic or surgical risk;
  • a preference for an option with lower reported rates of ejaculatory dysfunction or urinary incontinence in some studies, while recognising that these complications can still occur;
  • catheter-dependent urinary retention where obstruction from BPH is considered reversible and bladder contractility is adequate; or
  • recurrent or refractory bleeding shown to arise from the prostate in selected circumstances.

Current European Association of Urology guidance recommends offering PAE to men with moderate-to-severe LUTS due to benign prostatic obstruction who want a minimally invasive option and accept that outcomes may be less optimal than TURP. The American Urological Association also permits PAE as a treatment option when performed by appropriately trained clinicians, but grades the evidence as conditional.

What assessment is needed before PAE?

A large prostate does not prove obstruction, and urinary symptoms are not always caused by the prostate. Appropriate assessment may include:

  • symptom and quality-of-life scoring;
  • urinalysis and urine culture when indicated;
  • PSA assessment and prostate-cancer evaluation appropriate to age and risk;
  • digital rectal examination;
  • urinary flow rate and post-void residual measurement;
  • ultrasound or MRI assessment of prostate size and anatomy;
  • cystoscopy where haematuria, urethral stricture, bladder-neck pathology, stones or bladder disease is suspected;
  • urodynamic studies when the diagnosis is uncertain, symptoms are mixed, bladder contractility may be poor, or prior pelvic treatment has complicated the picture; and
  • CT or MR angiographic assessment of pelvic arterial anatomy, renal function and contrast risk when requested by the interventional radiologist.

The best decisions are generally made jointly by a urologist and an experienced PAE interventional radiologist.

Potential advantages of PAE

Potential advantages include:

  • no prostate tissue resection and usually no general anaesthetic;
  • day-stay or short hospital admission in many patients;
  • lower reported rates of major bleeding and transfusion than some operative procedures in comparative studies;
  • low reported, but not zero, rates of urinary incontinence;
  • a lower reported likelihood of retrograde ejaculation than with TURP or enucleation procedures in available studies;
  • usefulness in some very large prostates and medically complex patients; and
  • preservation of later surgical options if symptoms persist or recur.

Caveats: what PAE may not do as well

Compared with TURP or endoscopic enucleation, PAE generally produces a less immediate and less pronounced improvement in urinary flow and objective relief of obstruction. A Cochrane review found that short-term symptom improvement may be similar to TURP, but the certainty of evidence was low and retreatment may be more likely after PAE. Meta-analyses and longer-term randomised data generally show stronger objective improvement after TURP. Comparisons across studies must be interpreted cautiously because patient selection, technique, follow-up and outcome definitions differ.

PAE also does not provide prostate tissue for histology. Prostate cancer must therefore be considered and investigated before treatment rather than assumed to be excluded by a fall in prostate size or PSA afterward.

Technical success depends heavily on operator experience. Prostatic arteries are tiny, variable and sometimes severely atherosclerotic. Embolic material can rarely reach non-target vessels supplying the bladder, rectum or penis. Pre-procedure vascular imaging and cone-beam CT can reduce this risk but add iodinated contrast exposure and ionising radiation.

Side effects and complications

Common short-term effects form part of a post-embolisation syndrome and may include pelvic or perineal discomfort, urinary frequency and urgency, dysuria, fatigue, nausea, low-grade fever or a small amount of blood in the urine or semen. Temporary difficulty passing urine and the need for a catheter can occur.

Less common complications include urinary infection, access-site bruising or haematoma, contrast reaction, kidney injury, arterial injury, prostate infection or abscess, and passage of necrotic prostate tissue. Rare but important complications of non-target embolisation include ischaemic injury to the bladder, rectum or penis. Severe skin injury from fluoroscopic radiation is also rare but is a recognised procedural concern, particularly during prolonged or technically difficult cases.

Contraindications and reasons to pause

PAE is generally unsuitable, or requires correction and specialist review first, when there is:

  • an active urinary tract or systemic infection;
  • suspected or untreated prostate or bladder cancer requiring diagnostic clarification;
  • symptoms predominantly caused by urethral stricture, bladder-neck contracture, bladder stone, neurogenic dysfunction, overactive bladder or another non-BPH condition;
  • a poorly contractile or decompensated bladder unlikely to empty even if outlet resistance is reduced;
  • severe pelvic arterial atherosclerosis, occlusion, tortuosity or anatomy that prevents safe selective catheterisation;
  • an uncorrectable bleeding disorder;
  • a severe iodinated-contrast allergy that cannot be safely managed;
  • significant renal impairment where contrast risk is unacceptable; or
  • inability to tolerate arterial access, fluoroscopy or the required aftercare.

Small prostate size is not an absolute prohibition, but it makes careful confirmation of the cause of obstruction particularly important and may reduce the likelihood of benefit. A prominent obstructing median lobe is not automatically a contraindication in experienced hands, although prostate anatomy should be considered alongside all alternative treatments.

Can PAE be performed after prostate radiotherapy?

Potentially yes, but prior pelvic or prostate radiotherapy is not a routine indication, and the decision must be individualised. It is neither sensible to call radiotherapy an automatic absolute contraindication nor appropriate to assume that PAE will relieve every post-radiation urinary symptom.

After radiotherapy, poor flow, urgency, frequency, pain, retention or bleeding may result from:

  • persistent benign prostatic obstruction;
  • radiation cystitis and reduced bladder capacity;
  • detrusor overactivity or poor bladder contractility;
  • urethral stricture or bladder-neck stenosis;
  • prostate-cancer recurrence or progression;
  • infection, stones or clot retention; or
  • a combination of these problems.

PAE is most likely to help only when a meaningful component of the problem is supplied by vascular, enlarged prostate tissue or confirmed prostatic obstruction. It will not correct a urethral stricture, a scarred bladder neck, radiation cystitis, a small fibrotic low-capacity bladder or detrusor failure.

Evidence specifically studying PAE for BPH-type obstruction after completed radiotherapy is sparse. Most major BPH trials did not establish a dedicated post-radiotherapy evidence base. Radiotherapy can also alter pelvic tissues and small blood vessels, making angiographic anatomy and tissue response less predictable. For that reason, these patients should be assessed in a multidisciplinary setting and often benefit from cystoscopy, flow and residual testing, imaging and formal urodynamics before treatment.

PAE has been studied in men with prostate cancer and is being investigated before radiotherapy to reduce gland size and urinary symptoms. Embolisation has also been used for refractory bleeding of prostatic origin, including bleeding associated with malignancy or radiation. However, embolisation for life-threatening radiation-related haematuria may target vesical or other pelvic arteries and is a different clinical problem from PAE for benign outlet obstruction. These two indications should not be confused.

In a post-radiotherapy patient, PAE may therefore be reasonable when:

  1. recurrent cancer, infection and urethral or bladder-neck stenosis have been excluded or appropriately managed;
  2. investigations demonstrate an enlarged, vascular prostate with genuine outlet obstruction;
  3. bladder function is adequate enough to benefit from reducing resistance;
  4. pelvic arterial anatomy permits safe selective embolisation; and
  5. the patient understands that outcome data are limited and that further treatment may still be required.

How does PAE compare with surgery?

There is no universally “best” procedure. TURP, GreenLight laser, HoLEP or other enucleation procedures usually provide faster and more complete mechanical relief of obstruction. PAE is less invasive and some comparative studies report fewer ejaculatory or perioperative adverse effects; however, symptom relief can be slower, objective improvement may be smaller and retreatment may be more likely.

The right option depends on prostate size and configuration, the severity and cause of symptoms, bladder function, cancer risk, medical fitness, sexual priorities, arterial anatomy, previous pelvic treatment and the patient’s tolerance for the possibility of later retreatment.

The take-home message

PAE is an available treatment option for selected men with symptomatic benign prostatic obstruction. The Wesley Hospital P-EASY studies contribute Australian randomised and urodynamic data on symptoms, quality of life and obstruction, but their findings should be considered with the study designs, sample sizes, follow-up and declared author relationships.

It remains essential to diagnose the cause of symptoms before treating the scan. PAE is not a cure for every urinary problem and does not replace cancer assessment, cystoscopy or urodynamics when these are clinically indicated. After radiotherapy, PAE may be technically and clinically possible, but the evidence is limited and patient selection must be particularly rigorous.

References and further reading

  1. Brown N, et al. P-EASY ADVANCE: a randomised controlled trial of prostate embolisation versus medication for BPH. BJU International. 2024. doi: 10.1111/bju.16479.
  2. Brown N, et al. P-EASY PLUS: preliminary and follow-up urodynamic studies. BJU International. 2025. doi: 10.1111/bju.16808.
  3. Mark P, Brown NI, Ormiston WEL. Current considerations in prostate artery embolisation. CVIR Endovascular. 2026;9:45. doi: 10.1186/s42155-026-00689-5.
  4. European Association of Urology. Guidelines on the Management of Non-neurogenic Male LUTS: Disease Management. Current online edition accessed September 2026.
  5. Sandhu JS, et al. Management of Lower Urinary Tract Symptoms Attributed to BPH: AUA Guideline Amendment 2023. Journal of Urology. 2024;211:11–19. doi: 10.1097/JU.0000000000003698.
  6. Jung JH, et al. Prostatic arterial embolisation for the treatment of lower urinary tract symptoms in men with BPH. Cochrane Database of Systematic Reviews. 2022. Cochrane evidence summary.
  7. Müllhaupt G, et al. Prostatic artery embolisation versus TURP for benign prostatic obstruction: long-term outcomes of a randomised trial. European Urology. 2024. PubMed record.
  8. Zumstein V, et al. Prostatic artery embolization versus standard surgical treatment for LUTS secondary to BPH: systematic review and meta-analysis. European Urology Focus. 2019;5:1091–1100. doi: 10.1016/j.euf.2018.09.005.
  9. Parikh N, et al. Prostate artery embolization in the setting of prostate cancer. Seminars in Interventional Radiology. 2025. Full text.
  10. Kably I, et al. Prostatic artery embolization in refractory haematuria of prostatic origin. Techniques in Vascular and Interventional Radiology. 2020. PubMed record.
  11. Therapeutic Goods Administration. Advertising health services that involve therapeutic goods. Updated 18 June 2026.
  12. Therapeutic Goods Administration. General requirements for advertising therapeutic goods to the public. Updated 11 March 2025.
  13. Australian Health Practitioner Regulation Agency. Advertising guidelines and other guidance. Accessed 22 September 2026.

Australian publication and advertising statement

This article is intended as balanced disease and treatment education. It does not advertise a named embolic product, catheter, medicine or device; offer an inducement; use testimonials; promise a cure; or claim that PAE is safe, risk-free, superior or effective in every case. Mention of the TGA, Ahpra, professional guidelines, a hospital, a journal or an award does not imply endorsement of this article, the author or the treatment.

Clinical claims are linked to identified publications and should be reviewed when the article is updated. Any future addition of brand names, booking prompts, prices, before-and-after images, patient stories, sponsored links or manufacturer-supplied material may change the regulatory character of the page and should undergo a fresh compliance review.

This article provides general information current at the stated review date and is not personal medical advice. It does not establish a doctor–patient relationship. Benefits and risks differ between individuals. Suitability for PAE should be decided after assessment by appropriately qualified clinicians, commonly including a urologist and an interventional radiologist. Patients should seek urgent medical care for inability to pass urine, fever or sepsis symptoms, severe pain, heavy bleeding or clot retention.

PAE BJU article

Urinary Incontinence After Prostatectomy and Salvage Radiotherapy

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Why leakage may become more complex after both treatments

Urinary leakage after radical prostatectomy is common in the early recovery period and usually improves with healing and pelvic floor rehabilitation. Some men, however, require salvage radiotherapy because their PSA remains detectable or rises after surgery.

Radiotherapy can help control recurrent prostate cancer, but it may also affect tissues that have already been altered by surgery. Radiation can cause progressive scarring, reduced blood supply and loss of elasticity in the urethra, bladder neck and bladder. These effects may develop months or even years later.

As a result, leakage after prostatectomy and salvage radiotherapy is not always caused by a weak urinary sphincter alone. A man may have:

  • Stress urinary incontinence: leakage with coughing, standing, lifting, walking or exercise because the sphincter does not close effectively.
  • Urgency urinary incontinence: leakage accompanied by a sudden, difficult-to-defer urge, often caused by an overactive or irritated bladder.
  • Overflow leakage: leakage associated with poor bladder emptying, a weak bladder muscle or obstruction.
  • Mixed incontinence: a combination of stress and urgency leakage.
  • Radiation-related complications: bladder-neck contracture, urethral stricture, radiation cystitis, poor bladder compliance, fistula, tissue necrosis or, in severe cases, a severely damaged bladder outlet.

Correctly identifying the cause is essential. Tightening the outlet when the bladder cannot store or empty safely may replace one problem with another.

When should the problem be assessed?

Continence can continue to improve during the first year after prostatectomy. Pelvic floor muscle training should begin early, and surgical treatment may be considered as early as six months when severe leakage is clearly not improving. Persistent, bothersome stress incontinence at approximately 12 months deserves formal assessment.

Following salvage radiotherapy, earlier review is appropriate if there is:

  • worsening leakage;
  • blood in the urine;
  • recurrent urinary infection;
  • pain, burning or severe urgency;
  • a weak stream or difficulty emptying;
  • urinary retention;
  • pelvic or perineal pain; or
  • urine leaking through an abnormal opening.

Visible haematuria, fever, inability to pass urine or severe pain requires prompt medical attention.

Investigating incontinence after salvage radiotherapy

1. A careful history

The first step is to establish what type of leakage is occurring, when it began and whether it changed after radiotherapy. Important questions include:

  • Is leakage triggered by activity, or by urgency?
  • How many pads are used, and how wet are they?
  • Is the patient dry at night or when lying down?
  • Is there a weak stream, straining or incomplete emptying?
  • Are there recurrent infections, haematuria or pelvic pain?
  • Were there previous bladder-neck or urethral procedures?
  • How much does leakage affect work, exercise, sleep, intimacy and quality of life?

Manual dexterity and cognition are also important if an artificial urinary sphincter is being considered, because the patient must be able to locate and operate a small scrotal pump.

2. Bladder diary and pad assessment

A three-day bladder diary records fluid intake, voided volumes, urgency and leakage. Pad number gives a useful impression, but pads differ greatly. A 24-hour pad-weight test can quantify the actual volume lost and help grade severity and monitor progress.

3. Examination and basic tests

Assessment commonly includes:

  • abdominal, genital, perineal and neurological examination;
  • observation for leakage while coughing or standing with a comfortably full bladder;
  • urinalysis and urine culture when infection is suspected;
  • uroflowmetry;
  • ultrasound measurement of the post-void residual; and
  • renal function testing or upper-tract imaging when clinically indicated.

4. Cystoscopy

Cystoscopy is particularly important before continence surgery in a previously irradiated urinary tract. It allows the urologist to inspect the urethra, bladder neck and bladder for:

  • urethral stricture or bladder-neck contracture;
  • radiation damage, stones or tumour;
  • erosion from a previous implant;
  • tissue quality and sphincter appearance; and
  • fistula or necrosis in complex cases.

Any clinically important obstruction or unstable urethral disease usually needs to be treated and shown to be stable before an anti-incontinence device is implanted.

What is the role of urodynamic studies?

Urodynamics is not mandatory for every man with straightforward stress leakage. It becomes more useful when symptoms are mixed, the diagnosis is uncertain, previous radiation has made the situation more complex, or the result may change treatment.

The study can assess:

  • stress leakage and sphincter weakness;
  • involuntary bladder contractions;
  • bladder capacity and sensation;
  • reduced bladder compliance or unsafe storage pressures;
  • obstruction;
  • weak bladder contraction; and
  • the ability of the bladder to empty against a future sling or sphincter cuff.

Urodynamics is especially worth considering when there is marked urgency, nocturnal leakage, retention, a raised residual, poor flow, recurrent infection, prior outlet reconstruction or concern about a small, painful or poorly compliant radiation-damaged bladder.

The test does not simply decide whether a man “qualifies” for an operation. Its value is in identifying bladder dysfunction that should be treated first or a bladder that may not tolerate additional outlet resistance.

Initial and non-surgical management

Pelvic floor rehabilitation

Supervised pelvic floor muscle training can improve control and teach correct muscle activation. It is most useful early after prostatectomy but may still improve coping and control later. Repeated forceful exercises are not always better; poor technique can worsen pelvic tension or urgency.

Bladder and lifestyle measures

Management may include weight reduction where relevant, treating constipation, moderating caffeine and alcohol, adjusting the timing of fluids and diuretics, bladder training and treating urinary infection. Antimuscarinic medication or a beta-3 agonist may help an overactive-bladder component, but medication does not restore a damaged sphincter.

Pads, sheaths and clamps

Absorbent pads remain a practical option for mild leakage or while awaiting treatment. A condom drainage sheath can direct urine into a leg bag when penile skin and anatomy permit.

A penile clamp may provide short-term control for selected men with good sensation, intact skin and adequate bladder emptying. It must be released regularly and should not be used overnight. Extra caution is required after radiation because pressure injury may heal poorly.

Catheter options

Catheters manage drainage; they do not repair stress incontinence. They may nevertheless be appropriate when there is retention, very poor emptying, severe frailty, failed reconstruction or a need for temporary urinary control.

Intermittent self-catheterisation

Intermittent self-catheterisation is generally preferred when the bladder fails to empty but the patient has sufficient dexterity and urethral access. It avoids a continuously indwelling tube, although irradiated strictures or a false passage may make catheterisation difficult.

Long-term urethral catheter

An indwelling urethral catheter may be necessary in selected patients, but long-term use can cause infection, discomfort, blockage, bladder stones, urethral erosion and further outlet damage. A catheter passing through an activated AUS cuff can also cause serious urethral erosion; healthcare providers must be told that an AUS is present and the device should be deactivated before urethral instrumentation.

Suprapubic catheter

A suprapubic catheter enters the bladder through the lower abdomen. For long-term drainage it often avoids continuing urethral pressure and may be easier to manage than a urethral catheter. It still requires regular changes and carries risks including infection, blockage, bladder stones, leakage and skin problems.

Male sling versus artificial urinary sphincter

Male sling

A male sling supports and repositions or compresses the urethra. Its advantages include no scrotal pump and no need to operate the device each time the patient urinates. In carefully selected, non-irradiated men with mild-to-moderate stress incontinence, a sling can be effective.

However, previous pelvic radiotherapy is a recognised predictor of poorer sling outcomes. Fibrosis limits urethral mobility and tissue recovery, and moderate-to-severe leakage further reduces success. A sling may still be discussed in a highly selected patient with very mild leakage, good residual sphincter function and a stable, healthy-looking urethra, but expectations must be conservative.

Artificial urinary sphincter (AUS)

The AUS consists of a fluid-filled cuff around the urethra, a pressure-regulating balloon and a pump in the scrotum. The cuff stays closed to control leakage. The patient squeezes the pump to open it temporarily when passing urine.

For men with moderate-to-severe stress incontinence, the AUS remains the most established surgical treatment. Importantly, the AUA/GURS/SUFU guideline recommends offering an AUS rather than a male sling or adjustable balloons to men seeking surgery after primary, adjuvant or salvage radiotherapy.

Radiation does not make AUS implantation impossible, but outcomes are less predictable than in non-irradiated men. Radiation increases the risks of urethral erosion, infection, tissue atrophy, revision and device removal. Mechanical parts also have a limited lifespan, so further surgery may eventually be required.

Practical comparison

Consideration Male sling Artificial urinary sphincter
Best-established role Mild-to-moderate stress leakage in selected men Moderate-to-severe stress leakage
Previous salvage radiotherapy Lower success; generally not preferred Guideline-preferred surgical option, with higher complication risk than in non-irradiated men
Patient operation No pump Scrotal pump must be squeezed for each void
Manual dexterity required Minimal Yes
Retention risk Possible Possible if device is not cycled correctly or obstruction develops
Long-term considerations Persistent leakage or failure may require AUS Mechanical failure, erosion, infection or atrophy may require revision or removal

Neither operation guarantees complete dryness. The choice should consider pad weight, bladder function, urethral health, prior strictures or surgery, dexterity, patient priorities and the reconstructive surgeon’s assessment.

When an AUS or sling is not enough

A small group of men develop a severely scarred, painful or repeatedly obstructed outlet, sometimes called a devastated bladder outlet. This may include recurrent bladder-neck contracture or urethral stricture, fistula, radionecrosis, repeated AUS erosion, severe radiation cystitis or an unsafe low-capacity bladder.

Further implant surgery may then be unlikely to succeed. The priority changes from preserving normal voiding to obtaining dependable drainage, protecting the kidneys and improving quality of life.

Options at a specialist reconstructive centre may include:

  • long-term suprapubic drainage;
  • closure of the bladder neck with a suprapubic catheter in selected cases;
  • a catheterisable abdominal channel in carefully selected patients;
  • an ileal conduit, in which urine drains through a short segment of bowel to a urostomy bag on the abdomen;
  • another form of continent urinary diversion in selected fit patients; or
  • cystectomy with urinary diversion when the bladder is severely painful, contracted, bleeding, fistulating or otherwise unsalvageable.

These are major, irreversible procedures with substantial risks. They should be considered only after detailed imaging and functional assessment, review of cancer status, discussion with an experienced reconstructive team and consultation with a stomal therapy nurse.

A sensible treatment pathway

  1. Define the leakage: stress, urgency, overflow or mixed.
  2. Measure its severity: diary, pads and preferably pad weight.
  3. Check storage and emptying: urine testing, flow and residual; use urodynamics when the findings may alter treatment.
  4. Inspect the outlet: cystoscopy before implant surgery, particularly after radiation.
  5. Treat infection, obstruction and bladder dysfunction first.
  6. Use conservative or catheter strategies when appropriate.
  7. For persistent radiated stress incontinence, discuss AUS as the usual preferred operation.
  8. Reserve sling surgery for exceptional, carefully selected radiated patients after frank counselling.
  9. Refer severe outlet or bladder destruction to a high-volume reconstructive centre to discuss reconstruction versus diversion.

The take-home message

Urinary incontinence after prostatectomy and salvage radiotherapy is treatable, but it needs more than a pad count and a one-size-fits-all operation. The bladder, sphincter and urethra must each be assessed.

For straightforward sphincter weakness after radiation, the artificial urinary sphincter usually offers the most reliable surgical option, although radiation increases the likelihood of erosion and future revision. A male sling is less invasive but is less dependable in irradiated tissue. When the outlet or bladder is severely damaged, catheter drainage, bladder-neck closure or urinary diversion may provide a safer and more durable solution than repeated continence procedures.

This article provides general information and does not replace an individual assessment. Treatment should be tailored to the patient’s symptoms, examination, bladder function, urethral condition, cancer status and personal priorities.

References

  1. Breyer BN, Kim SK, Kirkby E, et al. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). Journal of Urology. 2024. AUA guideline | Journal update
  2. European Association of Urology. EAU Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms: urinary incontinence assessment and treatment. Current online edition. EAU guideline
  3. American Urological Association, ASTRO and SUO. Salvage Therapy for Prostate Cancer Guideline. AUA/ASTRO/SUO salvage therapy guideline
  4. National Institute of Diabetes and Digestive and Kidney Diseases. Urodynamic testing. NIDDK patient information
  5. British Association of Urological Surgeons. Urinary diversion into an ileal conduit. BAUS patient information

Evidence note: Most data specific to men who have undergone both prostatectomy and salvage radiotherapy come from observational series rather than large randomised trials. Recommendations therefore combine guideline evidence, reconstructive-urology experience and individualised shared decision-making.

Radical Prostatectomy After Radiation Therapy for Prostate Cancer

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When prostate cancer returns after radiotherapy

Radiotherapy, whether external-beam radiation or brachytherapy can provide excellent long-term control of localised prostate cancer. However, a rising prostate-specific antigen (PSA) after treatment may indicate that the cancer has returned.

This does not automatically mean that the cancer is still in the prostate, nor does every PSA rise require immediate treatment. Recurrence may be confined to the prostate, present in lymph nodes or bones, or involve more than one site. Some recurrences also progress slowly enough that surveillance may be appropriate.

When clinically significant cancer is proven to have returned within the irradiated prostate, with no evidence of spread elsewhere, removal of the prostate may still offer a chance of cure. This operation is called a salvage radical prostatectomy.

What is a salvage radical prostatectomy?

A salvage radical prostatectomy removes the entire prostate and seminal vesicles after previous prostate radiotherapy. Depending on the cancer and imaging findings, pelvic lymph nodes may also be removed.

The operation may be performed using robotic-assisted or open surgery. A robotic approach can improve magnification and access, but it does not remove the biological effects of previous radiation. Surgeon and centre experience are therefore more important than the label attached to the surgical technique.

Salvage surgery is technically more difficult than a prostatectomy performed before radiotherapy. Radiation can cause:

  • scarring and fibrosis around the prostate;
  • loss of the normal tissue planes between the prostate, bladder and rectum;
  • reduced tissue blood supply;
  • poorer tissue healing; and
  • pre-existing damage to urinary, erectile or bowel function.

For these reasons, salvage prostatectomy should generally be undertaken in a centre with specific experience in complex prostate cancer surgery and access to multidisciplinary care.

When might salvage surgery be considered?

The aim is to identify a man who has a meaningful risk from his recurrent cancer, but whose disease still appears curable with local treatment. Possible indications include:

  • a rising PSA after radiotherapy, commonly assessed using the Phoenix definition: a PSA rise of at least 2 ng/mL above the lowest PSA reached after treatment;
  • prostate cancer confirmed on biopsy after radiotherapy;
  • imaging suggesting that the recurrence is confined to the prostate or immediate surrounding tissues;
  • no evidence of distant metastatic disease;
  • a life expectancy long enough to benefit from curative treatment, often more than 10 years;
  • good general health and fitness for major surgery;
  • acceptable baseline bladder function; and
  • willingness to accept a higher risk of urinary and sexual side effects than with a primary prostatectomy.

Factors such as the PSA level, PSA doubling time, interval since radiotherapy, biopsy Grade Group, clinical stage and the original cancer characteristics help estimate whether salvage treatment is likely to be worthwhile.

Assessment before considering surgery

A rising PSA is the beginning of the assessment—not the final diagnosis. Investigations commonly include:

Review of the original treatment

The radiation dose and field, use of brachytherapy, previous androgen-deprivation therapy, original biopsy grade and pre-treatment imaging should all be reviewed.

Multiparametric MRI

MRI can help identify the site and extent of a local recurrence, assess the seminal vesicles, bladder neck and rectal interface, and guide biopsy. Interpretation after radiation can be challenging and benefits from specialist radiological expertise.

PSMA PET/CT

PSMA PET/CT is used to look for disease in lymph nodes, bones or other organs. Finding metastatic disease usually changes the treatment plan and may mean that removing the prostate would not provide the expected benefit. Very small-volume disease can still be below the resolution of any scan.

Prostate biopsy

Major guidelines recommend pathological confirmation before potentially morbid local salvage therapy. Biopsy can confirm viable cancer, determine its grade and help distinguish clinically important recurrence from post-radiation change. Both targeted and systematic sampling may be considered.

Urinary-function assessment

Assessment may include symptom scores, urine testing, urinary-flow measurement, residual urine ultrasound and cystoscopy. Urodynamic testing may be helpful when there is significant urgency, leakage, poor flow, retention or uncertainty about bladder function.

Who may not be a good candidate?

Salvage prostatectomy is less likely to be appropriate when:

  • metastatic or extensive nodal disease is present;
  • the cancer is unlikely to be completely removable;
  • life expectancy is limited by age, frailty or other illness;
  • the recurrence is low risk and unlikely to threaten health;
  • severe urinary or bowel damage already exists after radiation; or
  • the anticipated harms of surgery outweigh the probability of cancer control.

These are not absolute rules. Individual circumstances should be reviewed by a multidisciplinary team involving urology, radiation oncology, medical oncology, radiology and pathology.

What are the potential benefits?

For carefully selected men, salvage prostatectomy can:

  • remove the recurrent cancer and provide complete pathological staging;
  • provide durable PSA control without immediately committing the patient to lifelong hormonal therapy; and
  • offer a possibility of cure when disease is truly confined to the prostate.

Published results vary considerably because most evidence comes from retrospective series involving highly selected patients. The European Association of Urology reports five-year biochemical recurrence-free estimates broadly around 41–52% in a large contemporary systematic review, while older selected series have reported ranges of approximately 47–82%. A broader meta-analysis of all local salvage approaches found roughly 50–60% five-year recurrence-free survival, without clear evidence that one approach was oncologically superior. These figures should not be interpreted as a personal prediction.

Cancer control is generally more favourable when the PSA is lower, the recurrent tumour is organ-confined, the cancer grade is lower, the PSA doubling time is longer and there is no nodal or distant disease.

Side effects and complications

Complication rates vary with baseline function, radiation type and dose, disease extent, surgical technique, definitions used in studies and surgeon experience. Results from specialist centres may not apply everywhere.

Urinary incontinence

Loss of urinary control is one of the most important risks. Radiation may already have affected the sphincter, bladder and urethral tissues, and surgery removes the prostate through which the urethra passes.

Leakage may range from mild stress incontinence to severe continuous leakage. Pelvic-floor rehabilitation can help, but some men may later require a male sling or artificial urinary sphincter. Continence outcomes reported in the literature vary widely because studies use different definitions; the risk of significant or persistent leakage is clearly higher than after primary prostatectomy.

Erectile dysfunction

Erectile function is often already impaired by radiotherapy, age, vascular disease or hormonal treatment. Preservation of the erectile nerves may be unsafe or technically impossible because of tumour location and radiation fibrosis. Consequently, erectile dysfunction after salvage prostatectomy is very common and recovery of unassisted erections is uncommon.

Rehabilitation and treatment options include tablets, vacuum devices, penile injections and penile prosthesis surgery. As with any radical prostatectomy, ejaculation and natural fertility are lost because the prostate and seminal vesicles are removed.

Bladder-neck contracture or urethral narrowing

Scar tissue may develop where the bladder is reconnected to the urethra. This can cause a weak stream, straining, incomplete emptying, retention or recurrent infection. Treatment may require endoscopic incision or dilatation, sometimes more than once. Repeated procedures can worsen incontinence.

Urine leak and delayed healing

The new bladder-to-urethra join may heal slowly because irradiated tissues have reduced blood supply. A urinary catheter may need to remain in place longer, and imaging may be required before its removal. Persistent leakage can require drainage or further intervention.

Rectal injury and urinary fistula

The rectum can be densely adherent to the prostate after radiotherapy. Rectal injury is uncommon in expert contemporary practice but occurs more often than during primary prostatectomy and can be serious. It may require repair, temporary bowel diversion or, rarely, more extensive surgery. An abnormal connection between the urinary tract and rectum—a rectourinary fistula—is rare but particularly difficult to treat.

Other surgical risks

Other possible complications include bleeding or transfusion, infection, blood clots, lymphocele after lymph-node dissection, injury to nearby structures, anaesthetic complications, chronic pelvic pain and the need for further procedures.

Cancer may still recur

Even when preoperative imaging suggests local disease, microscopic cancer may already exist outside the prostate. PSA may therefore remain detectable or rise again after surgery. Further treatment—such as hormonal therapy, systemic therapy or selected metastasis-directed treatment—may still be required.

Are there alternatives?

Depending on the cancer, previous treatment, anatomy, urinary function and patient priorities, alternatives may include:

  • active monitoring for a slow or low-risk recurrence;
  • androgen-deprivation therapy, sometimes with additional systemic treatment;
  • salvage brachytherapy or stereotactic re-irradiation;
  • cryotherapy;
  • high-intensity focused ultrasound (HIFU); or
  • focal salvage treatment in carefully selected cases.

No single salvage treatment is best for every patient. Available studies are mostly non-randomised and use differing definitions. A large meta-analysis found broadly similar five-year cancer control among local salvage methods, but severe urinary toxicity was higher after salvage prostatectomy than after modern re-irradiation approaches. Treatment should therefore be selected through shared decision-making rather than on cancer-control figures alone.

The bottom line

Radical prostatectomy after prostate radiotherapy is possible and can be curative, but it is not a routine operation. The best candidate is generally a fit man with biopsy-proven, clinically significant recurrence confined to the prostate, no metastatic disease on appropriate staging, a meaningful life expectancy and a clear understanding of the potential functional consequences.

Accurate staging, confirmation by biopsy, assessment of baseline urinary function and review by an experienced multidisciplinary team are essential. The decision must balance the chance of durable cancer control against the higher risks of urinary incontinence, erectile dysfunction, urinary narrowing, poor healing and rectal complications.

This article provides general information and does not replace individual medical advice. Recommendations should be tailored to the pathology, imaging, previous radiation treatment, general health and preferences of each patient.

References

  1. European Association of Urology. EAU Guidelines on Prostate Cancer: Treatment—management of PSA failure after radiation therapy and salvage radical prostatectomy. Current online edition. https://uroweb.org/guidelines/prostate-cancer/chapter/treatment
  2. Morgan TM, et al. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline. Journal of Urology. 2024. https://www.auanet.org/guidelines-and-quality/guidelines/salvage-therapy-for-prostate-cancer
  3. Valle LF, et al. A systematic review and meta-analysis of local salvage therapies after radiotherapy for prostate cancer (MASTER). European Urology. 2021;80(3):280–292. doi:10.1016/j.eururo.2020.11.010.
  4. Grubmüller B, et al. Salvage radical prostatectomy for radio-recurrent prostate cancer: an updated systematic review of oncological, histopathological and functional outcomes and predictors. European Urology Focus. 2021;7(5):967–978.
  5. Perera M, et al. Morbidity of salvage radical prostatectomy: limited impact of the minimally invasive approach. European Urology Open Science. 2022;39:64–72.
  6. Zumsteg ZS, et al. The natural history and predictors of outcome following biochemical relapse in the dose-escalation era for prostate cancer patients undergoing definitive external beam radiotherapy. European Urology. 2015;67(6):1009–1016.

 

Focal Laser Therapy for Localised Prostate Cancer: What Do We Know?

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Focal therapy is an evolving approach to treating selected prostate cancers. Instead of treating or removing the entire prostate, it aims to destroy the identified cancer while preserving as much surrounding prostate tissue as possible.

One technique under investigation uses laser energy delivered through a fine fibre placed into the prostate. Early clinical reports are encouraging, but focal laser therapy is not suitable for every cancer and long-term evidence remains limited compared with established treatments such as radical prostatectomy and radiotherapy.

This article explains the disease, the principle of focal laser ablation, the early Guy’s Hospital pilot and the questions patients should consider before choosing treatment. It does not recommend a particular product, device or provider.

Understanding localised prostate cancer

Localised prostate cancer appears confined to the prostate on the available investigations. However, cancers vary greatly in their grade, size, position and biological behaviour.

Assessment commonly considers:

  • PSA level and PSA density
  • digital rectal examination findings
  • multiparametric prostate MRI
  • prostate-biopsy grade, often reported using Grade Group
  • number, position and extent of positive biopsy cores
  • whether clinically significant cancer is present in one or several parts of the prostate
  • the patient’s age, health, life expectancy and preferences
  • staging investigations where indicated

Some low-risk cancers may be monitored safely with active surveillance. Other cancers require treatment because their features suggest a meaningful risk of growth or spread.

What is focal therapy?

Focal therapy treats the known area of clinically significant cancer rather than the whole prostate. Depending on the extent and location of disease, treatment may target a small focus, a larger region or one side of the gland.

Energy sources used or investigated for focal therapy include:

  • high-intensity focused ultrasound
  • cryotherapy
  • irreversible electroporation
  • focal laser ablation
  • other thermal or energy-based techniques

These methods are not interchangeable. Each has different equipment, treatment planning, evidence, limitations and regulatory status.

How does focal laser ablation work?

Focal laser ablation delivers laser energy through a thin fibre positioned within the planned treatment area. The energy heats and destroys targeted tissue.

Placement may be performed through the perineum, the area between the scrotum and anus, with MRI and ultrasound information used to guide treatment planning and positioning. Temperature monitoring, cooling systems or other safeguards may be used according to the particular technique.

The intended advantage is to treat the cancer focus while reducing injury to structures involved in urinary continence, erections and bowel function. This is a treatment aim, not a guarantee. Damage to surrounding tissue and functional side effects remain possible.

What did the Guy’s Hospital pilot report?

Guy’s Hospital in London began a pilot involving 30 patients with localised prostate cancer. According to the hospital information reported by the BBC, assessment of the first 10 treated patients found no remaining cancer in the treated area in eight, while two had a small amount of residual cancer.

These figures should be interpreted cautiously:

  • they concern only the first 10 patients of a small pilot
  • they describe early findings in the treated area, not long-term cure
  • cancer may be present elsewhere in the prostate
  • follow-up was not long enough to establish durability, metastasis prevention or survival benefit
  • results from carefully selected research participants may not apply to all patients

The pilot includes ongoing follow-up, including imaging. Larger studies, longer observation and peer-reviewed comparative evidence are needed before firm conclusions can be drawn about long-term cancer control and functional outcomes.

Who might be considered for focal therapy?

Focal therapy may be discussed for carefully selected patients whose clinically significant cancer can be identified and targeted while untreated areas can be monitored reliably.

Selection may take account of:

  • MRI-visible disease
  • biopsy confirmation and cancer grade
  • location, volume and number of cancer foci
  • proximity to the urethra, urinary sphincter, rectum and neurovascular structures
  • prostate size and anatomy
  • previous prostate treatment
  • ability and willingness to undergo close follow-up and repeat biopsy
  • availability of appropriate expertise and governance

Multifocal, poorly defined, extensive or higher-risk cancer may make a focal approach unsuitable. An apparently single MRI lesion does not prove that no important cancer exists elsewhere in the gland.

What assessment is needed beforehand?

Accurate mapping of the cancer is essential. Depending on the patient, assessment may include:

  • review of PSA history
  • high-quality multiparametric MRI
  • targeted and systematic transperineal biopsy
  • expert radiology and pathology review
  • staging imaging when indicated by risk
  • baseline urinary, erectile and bowel function assessment
  • discussion by a multidisciplinary prostate-cancer team

A treatment decision should not be based on MRI alone. Biopsy remains important for confirming the grade and distribution of cancer.

Potential advantages

Possible advantages for appropriately selected patients include:

  • treatment directed at the known cancer rather than the entire prostate
  • usually a shorter procedure and recovery than radical prostatectomy
  • potential for same-day discharge
  • a lower treatment burden for some patients
  • the possibility of preserving urinary and sexual function more often than with whole-gland treatment
  • retention of other treatment options if further cancer is later detected

These are potential advantages, not assured outcomes. Comparisons with surgery or radiotherapy are difficult because patient selection, outcome definitions and follow-up periods differ across studies.

Risks and limitations

Possible complications include:

  • blood in the urine or semen
  • discomfort, bruising or swelling
  • urinary infection
  • difficulty passing urine or temporary catheterisation
  • urinary retention
  • urethral narrowing
  • urinary urgency or leakage
  • erectile or ejaculatory changes
  • injury to tissue surrounding the prostate
  • residual cancer within the treated area
  • clinically significant cancer elsewhere in the prostate
  • need for repeat focal treatment or conversion to surgery or radiotherapy

Rare but serious complications may occur. The specific risk profile depends on the technology, treatment location, operator experience and individual anatomy.

Focal therapy does not remove the need for surveillance

Unlike radical prostatectomy, focal therapy leaves prostate tissue behind. PSA therefore remains detectable and cannot be interpreted in the same way as after complete prostate removal.

Follow-up may include:

  • regular PSA testing
  • clinical review
  • repeat MRI
  • targeted and systematic repeat biopsy
  • assessment of urinary and sexual function

Imaging alone may not exclude residual or recurrent cancer. Patients need to be willing to undergo structured, long-term surveillance and possible further biopsy or treatment.

How does it compare with established options?

Active surveillance

Active surveillance avoids or delays treatment in suitable patients with lower-risk disease. It involves scheduled PSA tests, MRI, examination and repeat biopsy. It avoids immediate treatment side effects but carries the burden of monitoring and the possibility that treatment will later be required.

Radical prostatectomy

Surgery removes the prostate and seminal vesicles and provides complete pathological assessment of the removed gland. It has extensive long-term evidence for selected patients but may cause urinary incontinence, erectile dysfunction, loss of ejaculation and other surgical complications.

Radiotherapy

External-beam radiotherapy and brachytherapy are established treatments for localised prostate cancer. Risks may include urinary, bowel and sexual effects, which can develop during treatment or later. Some patients also require androgen-deprivation therapy.

Focal therapy

Focal therapy attempts to balance cancer control with preservation of function. Its principal uncertainties are the selection of suitable patients, untreated cancer elsewhere in the prostate, definitions of treatment success and the lack of mature comparative and long-term cancer-control data.

What happens if cancer remains or returns?

Further management depends on the location and risk of the cancer, previous treatment and patient preference. Options may include:

  • continued surveillance in selected circumstances
  • repeat focal treatment
  • radical prostatectomy
  • radiotherapy
  • another appropriate cancer treatment

Salvage treatment after focal therapy may be technically more complex and can have different side-effect rates from primary treatment. Patients should discuss the available rescue options before choosing focal therapy, not only after treatment failure.

Australian regulatory status and access

Regulatory status, approved indications, availability, reimbursement and participation in clinical trials can change. A device being used in research overseas does not automatically mean that the same system is approved, routinely available or publicly funded in Australia.

Patients considering a particular technology should ask:

  • Is the exact device included in the Australian Register of Therapeutic Goods for the proposed use?
  • Is treatment being offered as standard care, through a clinical trial or under another access pathway?
  • What evidence supports this technique for my particular cancer?
  • What costs and follow-up procedures are involved?
  • Who will manage surveillance and any residual or recurrent cancer?

Current regulatory information should be confirmed directly through the Therapeutic Goods Administration and the treating institution. This article does not make a claim that any named focal-laser system is TGA approved.

Questions to ask your prostate-cancer team

  • What is my Grade Group and clinical risk category?
  • Is the cancer confined to one clearly targetable area?
  • How confident are we that significant cancer is not present elsewhere?
  • Is active surveillance a safe option for me?
  • What are the established alternatives and their long-term outcomes?
  • What evidence is available for this focal technique?
  • How will success be measured?
  • Will I need another biopsy?
  • What are the urinary, sexual and bowel risks?
  • What happens if the cancer is not completely treated or later recurs?
  • Is this standard treatment or part of a research study?

The bottom line

The early Guy’s Hospital experience adds to growing interest in focal laser treatment for localised prostate cancer. The reported initial findings are encouraging, but 10 early cases cannot establish long-term cure, comparative effectiveness or safety.

Focal therapy may be reasonable to discuss for carefully selected patients who understand the uncertainties and accept close surveillance. It should be considered alongside active surveillance, surgery and radiotherapy through shared decision-making with an experienced multidisciplinary team.

This article provides general disease education. It does not recommend or promote a particular therapeutic device, treatment system, clinician or health service and does not replace individual medical advice. Regulatory status and clinical evidence should be checked at the time treatment is considered.

References and further reading

Publication note

This is an original educational article, not a republication of the BBC report.

Prostate Abscess: A Rare but Serious Infection

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A prostate abscess is a collection of pus within the prostate gland. It usually develops as a complication of acute bacterial prostatitis when infection progresses despite treatment or when treatment has been delayed.

Prostate abscesses are uncommon, but they can become life-threatening if the infection spreads into the bloodstream. Early diagnosis, intravenous antibiotics and, when necessary, drainage of the abscess are essential.

What causes a prostate abscess?

Most prostate abscesses develop when bacteria enter the prostate from the urinary tract. The infection may begin in the bladder or urethra and travel backwards through the prostatic ducts.

Common bacteria include:

  • Escherichia coli
  • Klebsiella species
  • Pseudomonas species
  • Proteus species
  • Enterococcus species
  • Staphylococcus aureus, including resistant strains such as MRSA

Less commonly, bacteria reach the prostate through the bloodstream from an infection elsewhere in the body. Fungal and tuberculosis-related abscesses are rare but may occur in people with significant immune suppression.

Who is at increased risk?

A prostate abscess is more likely to develop in men with:

  • Diabetes, particularly when blood glucose is poorly controlled
  • A weakened immune system
  • Long-term corticosteroid or immunosuppressive treatment
  • HIV or another significant immune disorder
  • Difficulty emptying the bladder
  • Benign prostate enlargement
  • A urethral stricture
  • A long-term urinary catheter
  • Recent urinary tract instrumentation
  • Recent prostate biopsy or prostate surgery
  • Recurrent urinary tract infections
  • Chronic kidney disease or dialysis
  • Intravenous drug use
  • Acute bacterial prostatitis that is not improving with appropriate antibiotics

Diabetes is one of the most frequently identified risk factors. High blood glucose can impair the immune response and make infection more difficult to control.

How does a prostate abscess present?

The symptoms often resemble acute prostatitis or a severe urinary tract infection. A man may experience:

  • Fever, chills or shaking
  • Pain or burning when passing urine
  • Frequent or urgent urination
  • Difficulty starting or maintaining the urinary stream
  • Inability to pass urine
  • Pain in the pelvis, perineum, groin or lower back
  • Painful ejaculation
  • Blood in the urine
  • Cloudy or unpleasant-smelling urine
  • General weakness, nausea or confusion

On examination, the prostate may be enlarged, tender or feel unusually soft or fluctuant. However, the absence of a typical prostate examination does not exclude an abscess.

Forceful prostate massage should be avoided in someone with acute prostatitis or a suspected abscess because it may push bacteria into the bloodstream.

When should a prostate abscess be suspected?

A prostate abscess should be considered when a patient with acute prostatitis:

  • Remains febrile after approximately 48–72 hours of appropriate antibiotics
  • Becomes more unwell despite treatment
  • Develops urinary retention
  • Has persistent pelvic or perineal pain
  • Has recurrent infection with the same organism
  • Has diabetes, immune suppression or another major risk factor

Symptoms alone cannot reliably distinguish an abscess from uncomplicated prostatitis. Imaging is usually needed to confirm the diagnosis.

How is it diagnosed?

Initial investigations may include:

  • Urine microscopy and culture
  • Blood cultures, preferably before antibiotics when this does not delay treatment
  • Full blood count
  • Kidney function and electrolyte tests
  • Inflammatory markers
  • Blood glucose testing
  • Blood lactate and other sepsis investigations when the patient is seriously unwell

Imaging may be performed using:

Transrectal ultrasound

Transrectal ultrasound can demonstrate one or more fluid-filled cavities within the prostate. It can also be used to guide needle drainage.

CT scan

A CT scan of the pelvis is particularly useful when the patient is very unwell or when infection may have spread beyond the prostate. It can also identify urinary obstruction, stones or another source of infection.

MRI

MRI provides detailed images of the prostate and surrounding tissues. It may be helpful when ultrasound or CT findings are unclear, but it is not always the most practical first investigation in an emergency.

Is a prostate abscess an emergency?

A prostate abscess can lead to bloodstream infection, sepsis and septic shock. Patients with fever, shaking chills, confusion, low blood pressure, rapid breathing, severe weakness or inability to pass urine require urgent hospital assessment.

Emergency management may involve:

  • Immediate assessment for sepsis
  • Blood and urine cultures
  • Intravenous fluids
  • Prompt intravenous antibiotics
  • Pain relief
  • Monitoring of blood pressure, urine output and kidney function
  • Treatment of uncontrolled diabetes
  • Urgent urinary drainage if the bladder cannot empty
  • Early consultation with a urologist and, when appropriate, an infectious diseases physician

Antibiotics should not be delayed in a patient who is septic while waiting for scans or culture results.

If urinary retention is present, bladder drainage is required. A urethral catheter may sometimes be used carefully, but a suprapubic catheter inserted through the lower abdomen may be preferred when urethral catheterisation is difficult or likely to cause significant prostate irritation. The best approach depends on the patient’s condition and anatomy.

Treatment with antibiotics

All prostate abscesses require antibiotic treatment.

A patient who is systemically unwell will usually begin treatment with broad-spectrum intravenous antibiotics. The initial antibiotic choice depends on:

  • The likely source of infection
  • Local bacterial resistance patterns
  • Previous urine culture results
  • Recent hospital admission or antibiotic exposure
  • Recent catheterisation or urinary surgery
  • Kidney function
  • Drug allergies
  • The possibility of resistant bacteria or Staphylococcus aureus

Once culture results become available, treatment can be narrowed to an antibiotic that targets the identified organism and penetrates prostate tissue effectively.

After clear clinical improvement, intravenous treatment may be changed to an appropriate oral antibiotic. Treatment is usually longer than for a simple bladder infection and commonly continues for several weeks. The exact duration depends on the organism, abscess size, success of drainage, immune status and response to treatment.

Follow-up urine cultures and repeat imaging may be required to confirm that the infection and abscess have resolved.

Can antibiotics alone cure a prostate abscess?

Occasionally, a small abscess in a clinically stable patient can be treated with antibiotics and close observation. This is more likely to succeed when the collection is small, often less than approximately 1 cm, and drains naturally into the prostatic ducts.

There is no single size threshold that applies to every patient. Larger, multiloculated or persistent abscesses are less likely to resolve with antibiotics alone.

Drainage should be considered when:

  • The patient is septic or clinically deteriorating
  • Fever persists despite appropriate antibiotics
  • The abscess is relatively large
  • There are several abscess cavities
  • The abscess is not shrinking on repeat imaging
  • Urinary obstruction is present
  • The infecting organism is difficult to eradicate
  • The patient has diabetes or significant immune suppression
  • The infection repeatedly returns

Current European guidance recognises that both conservative treatment and drainage may be appropriate in selected patients, with abscess size and clinical response helping to guide the decision. EAU Guidelines on Urological Infections

How is a prostate abscess drained?

Several drainage techniques are available. The method chosen depends on the size and position of the abscess, whether it has multiple compartments, the patient’s condition and local expertise.

Transrectal ultrasound-guided aspiration

A needle is passed through the rectum into the abscess under ultrasound guidance, and the pus is aspirated.

Advantages include:

  • Minimally invasive treatment
  • Usually limited anaesthesia
  • Collection of pus for culture

However, the abscess may refill, particularly if it is large, thick-walled or divided into several compartments. Repeat aspiration may be needed.

Transperineal drainage

A needle or drain is inserted through the skin between the scrotum and anus under ultrasound or imaging guidance.

This approach avoids passing through the rectal wall and may allow a drainage catheter to remain temporarily. It can be useful for appropriately positioned abscesses or when repeated drainage is anticipated.

Transurethral drainage

A telescope is passed through the urethra, and the abscess cavity is opened internally so that it can drain into the urinary channel. This may be performed by incision, deroofing or limited resection of the involved prostate tissue.

Transurethral drainage is often considered when:

  • The abscess is large
  • There are multiple or deep cavities
  • Needle aspiration has failed
  • The abscess has recurred
  • Prostate enlargement is contributing to obstruction
  • Rapid and complete drainage is required

Possible complications include bleeding, urinary infection, temporary worsening of urinary symptoms, retrograde ejaculation, urethral stricture and, less commonly, urinary incontinence or injury to surrounding structures.

Open or laparoscopic surgery

Open, laparoscopic or robotic drainage is rarely required. It may be considered if the abscess extends outside the prostate, cannot be reached by less invasive methods or is associated with another condition requiring surgery.

Antibiotics plus effective drainage remain the central principles of treatment. Management of prostate abscess in the absence of guidelines and MSD Manual: Prostate Abscess

What happens after drainage?

The drained fluid is sent for microbiological testing. This is important because the organism within the abscess may differ from that found in the urine.

Following drainage, the patient usually continues antibiotics. Clinical improvement is monitored by checking:

  • Temperature and general wellbeing
  • Pain and urinary symptoms
  • White blood cell count and inflammatory markers
  • Kidney function
  • Blood glucose in patients with diabetes
  • Urine and blood culture results
  • Follow-up ultrasound, CT or MRI when indicated

Any contributing problem, such as bladder obstruction, a urethral stricture, a catheter or poorly controlled diabetes, should also be addressed to reduce the risk of recurrence.

What is the outlook?

With early recognition, appropriate antibiotics and adequate drainage, most prostate abscesses can be successfully treated.

Delayed treatment may result in:

  • Sepsis or septic shock
  • Spread of infection beyond the prostate
  • Fistula formation into nearby structures
  • Recurrent urinary infection
  • Chronic pelvic discomfort
  • Prolonged difficulty passing urine
  • Rarely, death from overwhelming infection

A prostate abscess should therefore be regarded as a potentially serious complication of prostatitis rather than an ordinary urinary infection.

When should you seek urgent medical attention?

Attend an emergency department urgently if you develop:

  • Fever or shaking chills with urinary symptoms
  • Confusion, faintness or severe weakness
  • Inability to pass urine
  • Severe pelvic or perineal pain
  • Rapid breathing or a racing heartbeat
  • Persistent fever despite antibiotics
  • Worsening symptoms after treatment for prostatitis

Early assessment is particularly important for men with diabetes, immune suppression, a urinary catheter or recent urinary tract surgery.

This information is intended for general education and does not replace individual medical assessment. A suspected prostate abscess requires urgent assessment by a medical practitioner and usually early involvement of a urologist.

So, if this is happening to you, attend your local Emergency Department ASAP, or if you are still OK, ask your GP for an urgent referral to see your local Brisbane Urologist Dr Jo Schoeman ASAP

Enlarged Prostate (BPH): Understanding Prescription Combination Therapy

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Benign prostatic hyperplasia (BPH), also called benign prostate enlargement, becomes more common as men get older. An enlarged prostate may narrow the urethra or affect the way the bladder works.

Possible symptoms include:

  • a slow or intermittent urinary stream
  • difficulty starting urination
  • straining to urinate
  • a feeling that the bladder has not emptied fully
  • urinary frequency or urgency
  • waking at night to urinate
  • dribbling after urination
  • urinary retention

These symptoms are not always caused by an enlarged prostate. Infection, overactive bladder, urethral narrowing, bladder stones, neurological conditions and prostate or bladder cancer can sometimes produce similar symptoms. An appropriate clinical assessment is therefore important before treatment is selected.

What treatments are available?

Management depends on symptom severity, prostate size, bladder emptying, general health and personal preferences. Options may include:

  • monitoring and lifestyle measures
  • prescription medicines
  • minimally invasive procedures
  • prostate surgery

No single option is best for every patient. A treatment that improves symptoms in one man may be unsuitable for another.

How prescription combination therapy works

For selected men, a doctor may prescribe two types of medicine together:

  1. An alpha blocker, such as tamsulosin, relaxes smooth muscle in the prostate and bladder neck. This may improve urine flow and symptoms relatively quickly, although response varies.
  2. A 5-alpha-reductase inhibitor, such as dutasteride or finasteride, alters the hormonal pathway involved in prostate growth. Over time, it may reduce prostate volume and lower the risk of urinary retention or BPH-related surgery in appropriately selected men.

These medicines are available only on prescription. They may be prescribed separately or, in some circumstances, in a fixed-dose combination. This article does not recommend a particular medicine or brand.

The prostate-reducing component acts gradually. Any benefit is generally assessed over months rather than days. Combination therapy is commonly considered as a longer-term treatment, but regular review remains important.

Who might be considered for combination therapy?

A doctor may consider combination treatment for a man who has moderate-to-severe urinary symptoms associated with a demonstrably enlarged prostate and an increased risk of BPH progression.

The decision may take account of:

  • how troublesome the symptoms are
  • prostate size and shape
  • PSA results, interpreted in clinical context
  • urinary flow rate
  • the amount of urine left in the bladder after voiding
  • previous urinary retention
  • the expected benefits, limitations and adverse effects of treatment
  • other illnesses and medicines
  • the patient’s preferences, including the importance of preserving sexual and ejaculatory function

Prostate size alone should not determine treatment. Some men with large prostates have few symptoms, while a smaller prostate can still cause obstruction because of its shape, a tight bladder neck or another condition.

Assessment before treatment

Depending on the individual, assessment may include:

  • a urinary, medical and medication history
  • a validated symptom questionnaire
  • physical examination, which may include a digital rectal examination
  • urine testing
  • PSA testing after discussion of its benefits and limitations
  • kidney-function blood tests
  • urinary flow measurement
  • ultrasound assessment of prostate size and post-void residual urine
  • a bladder diary
  • cystoscopy or urodynamic testing in selected cases

The purpose is to confirm the likely cause of the symptoms and identify complications or conditions that require a different approach.

Possible benefits and limitations

An alpha blocker may improve urine flow and some symptoms within days or weeks. It does not substantially shrink the prostate.

A 5-alpha-reductase inhibitor works more slowly. In men with prostate enlargement, it may reduce prostate volume and lower the long-term risk of acute urinary retention or BPH-related surgery. Not every patient will experience a worthwhile improvement.

Combination treatment may improve symptoms more than either medicine alone in appropriately selected patients, but it also exposes the patient to the adverse effects of both medicine classes. It controls BPH rather than permanently curing it. Symptoms may recur or progress, and a procedure may still be required.

Clinical-trial averages cannot predict an individual patient’s result. Benefits and harms should be reviewed with the prescribing doctor.

Possible adverse effects

Adverse effects differ between people. The Consumer Medicine Information supplied with the prescribed medicine should be read, and new or troublesome symptoms should be discussed with the prescriber or pharmacist.

Sexual and ejaculatory effects

Possible effects include:

  • reduced semen volume or absent ejaculation
  • semen passing backwards into the bladder
  • reduced sexual desire
  • difficulty achieving or maintaining an erection
  • changes in fertility or semen characteristics

Some sexual adverse effects have been reported to persist after a 5-alpha-reductase inhibitor is stopped, although their frequency, cause and predictors remain uncertain. Persistent symptoms deserve appropriate assessment.

Dizziness and low blood pressure

Alpha blockers may cause dizziness, light-headedness, weakness or, less commonly, fainting—particularly when standing up. The risk may be greater when treatment begins or when combined with other medicines that lower blood pressure. Patients who become dizzy should take care to avoid falls and seek medical advice.

Breast and other changes

5-alpha-reductase inhibitors may cause breast tenderness or enlargement. A breast lump, nipple discharge or persistent one-sided change requires medical assessment rather than being assumed to be a medicine effect.

Other reported adverse effects can include headache, tiredness, palpitations, nasal congestion, gastrointestinal discomfort, skin reactions, testicular symptoms and mood changes. The exact safety information depends on the medicine prescribed.

Seek urgent help

Urgent medical attention is appropriate for symptoms such as:

  • swelling of the face, tongue or throat, or difficulty breathing
  • collapse or fainting
  • a painful, prolonged erection
  • a severe blistering or peeling skin reaction
  • suicidal thoughts or severe psychological distress
  • inability to pass urine, especially with increasing lower abdominal pain

In Australia, call Triple Zero (000) in an emergency. Lifeline is available on 13 11 14 for crisis support. These services do not replace assessment by the treating clinician.

PSA monitoring

5-alpha-reductase inhibitors commonly lower PSA. This does not eliminate the possibility of prostate cancer.

A new PSA baseline may need to be established after treatment begins. Later results must be interpreted with knowledge that the patient is taking this type of medicine. A confirmed increase from the lowest PSA reached may require further assessment, even if the result falls within a laboratory’s usual reference range.

Patients should tell any clinician ordering or interpreting a PSA test about all current and recent prostate medicines.

Cataract or glaucoma surgery

Tamsulosin and some other alpha blockers are associated with intraoperative floppy iris syndrome, which may complicate cataract or glaucoma surgery.

Patients should tell their ophthalmologist about current or previous alpha-blocker use. They should not stop a prescribed medicine solely for an eye operation unless advised by the relevant treating clinicians, because stopping it may not remove the surgical risk.

Mood and persistent symptoms

Sexual, cognitive and mood symptoms have been reported during or after treatment with 5-alpha-reductase inhibitors. The evidence about persistent syndromes, their frequency and causation continues to evolve.

This uncertainty should be discussed without either assuming that persistent symptoms will occur or dismissing symptoms that a patient experiences. New depression, marked anxiety or sexual dysfunction should be reviewed. Suicidal thoughts require urgent assistance.

Monitoring treatment

Follow-up may include review of:

  • symptom response and quality of life
  • dizziness and postural blood pressure
  • sexual and ejaculatory function
  • mood changes
  • urinary flow and post-void residual urine
  • PSA results
  • kidney function when clinically indicated

Lack of early improvement does not necessarily mean the slower-acting component has failed. However, severe or worsening symptoms should not be managed by continuing medicine indefinitely without reassessment.

When might a procedure or surgery be considered?

A procedure may be discussed when there is:

  • recurrent or persistent urinary retention
  • catheter dependence
  • recurrent infection associated with poor bladder emptying
  • bladder stones
  • recurrent visible bleeding attributed to BPH
  • kidney or upper urinary tract effects from obstruction
  • a high or increasing post-void residual volume
  • persistent troublesome symptoms despite appropriate conservative treatment
  • unacceptable medicine adverse effects
  • a preference for a procedural option after informed discussion

Procedural choices include established operations and selected minimally invasive treatments. Suitability depends on prostate anatomy, bladder function, general health, bleeding risk, expected durability and the importance of preserving ejaculation. Each option has potential benefits, limitations and complications.

Questions to discuss with your doctor

  • What is the most likely cause of my urinary symptoms?
  • Is my prostate enlarged, and am I at risk of progression?
  • What are the reasonable alternatives, including observation, medicines and procedures?
  • How likely is each option to help in my circumstances?
  • What sexual, ejaculatory, blood-pressure and mood effects should I consider?
  • How will treatment affect the interpretation of my PSA?
  • When should treatment be reviewed or changed?
  • Which symptoms require urgent assessment?

The bottom line

Prescription combination therapy can be one option for selected men with bothersome urinary symptoms, prostate enlargement and a risk of BPH progression. It is not suitable for every urinary problem and does not guarantee that surgery will be avoided.

The choice should follow an individual assessment and a balanced discussion of expected benefit, possible harm, alternatives and the option of no immediate treatment. Do not start, stop or change a prescription medicine without advice from the prescribing clinician.

This article provides general educational information. It is not medical advice and does not promote or recommend a particular prescription medicine or brand. Treatment decisions should be made with an appropriately qualified health professional after individual assessment.

References and further reading

 

Focal Therapy for Prostate Cancer: Targeting the Cancer While Preserving the Prostate

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Established management of localised prostate cancer includes active surveillance for suitable low-risk disease and whole gland treatment with surgery or radiotherapy when treatment is indicated. ProFocal® is a newer focal approach that uses laser energy to destroy a selected cancerous area while leaving much of the surrounding prostate untreated.

This approach is known as focal laser therapy or focal laser ablation. Its intended aim is to control the treated cancer focus while reducing urinary and sexual side effects. Whether it provides cancer control equivalent to established whole-gland treatments over the long term has not been demonstrated.

Early Australian research is encouraging. However, ProFocal remains an investigational treatment, and important questions about its long-term cancer control have not yet been answered.

What is ProFocal therapy?

ProFocal is an Australian-developed focal therapy system designed to treat a carefully selected area of prostate cancer.

A fine laser applicator is inserted through the skin between the scrotum and anus, the perineum, and guided into the prostate using imaging. Laser energy heats the targeted tissue to a temperature that causes cancer-cell death.

The system incorporates cooling and real-time temperature monitoring. This is intended to make the area of ablation more predictable and to limit unintended heat damage to nearby structures such as the:

  • Urinary sphincter
  • Urethra
  • Bladder neck
  • Rectum
  • Neurovascular bundles involved in erections

Unlike radical prostatectomy, ProFocal does not remove the prostate. Unlike conventional radiotherapy, it does not expose the whole prostate to radiation.

Is ProFocal approved by the TGA?

This requires careful clarification.

As at September 2026, the manufacturer states that ProFocal is not included in the Australian Register of Therapeutic Goods, ARTG. It therefore does not have general TGA market authorisation for routine supply and use in Australia.

This is different from saying that the treatment has received unrestricted “TGA approval.”

ProFocal may be accessible in Australia through a clinical trial or a specific TGA pathway for an unapproved therapeutic good, such as the Authorised Prescriber Scheme or Special Access Scheme. These pathways permit access in defined circumstances; they are not equivalent to ARTG inclusion or routine TGA market authorisation. The applicable approval, governance and consent arrangements should be confirmed for the individual patient.

Authorised Prescriber access does not mean that the device has been entered on the ARTG or endorsed as routine standard treatment. Regulatory status, trial availability and funding arrangements should always be confirmed directly before treatment.

Medicare, private insurance and professional oversight in Australia

The Medicare Benefits Schedule (MBS) lists professional medical services subsidised by the Australian Government. As at September 2026, no specific MBS item for “ProFocal” or focal laser ablation of prostate cancer was identified in the current public MBS material reviewed for this article. This should not be interpreted as a definitive ruling on every component of an episode of care: consultations, anaesthesia, imaging, pathology or hospital services may each have different billing arrangements.

An MBS rebate for an associated service would not establish that ProFocal itself is TGA-approved, guideline-endorsed or proven effective. Conversely, lawful access through a TGA pathway does not guarantee Medicare or private-insurance funding. The Department of Health and Aged Care’s Medical Services Advisory Committee (MSAC) is the independent body that advises government on whether public funding of medical services and technologies is supported by evidence of safety, clinical effectiveness and cost-effectiveness.

The Australian Medical Association (AMA) is a professional representative body, not the regulator of therapeutic goods and not the agency that creates Medicare items. No AMA clinical guideline specifically recommending ProFocal was identified for this review. It would therefore be inappropriate to imply AMA endorsement. Relevant professional duties instead arise from the Medical Board of Australia’s code of conduct: patients should receive understandable information about the proposed treatment, reasonable alternatives, material risks, uncertainties, costs and any practitioner conflicts of interest so that consent is genuinely informed.

Who may be considered for ProFocal therapy?

ProFocal is principally being studied in men with localised, non-metastatic and MRI-visible prostate cancer.

In the first prospective phase II ProFocal study, eligible men had:

  • Prostate cancer confined to the prostate
  • An MRI-visible cancer target
  • ISUP Grade Group 2 or 3 disease
  • A PSA of 15 ng/mL or lower
  • A clinical stage of T2c or lower
  • Biopsy findings corresponding with the abnormality seen on MRI

Outside a clinical trial, suitability would need to be assessed individually by a multidisciplinary prostate cancer team.

A potential candidate generally requires a cancer that can be clearly identified, biopsied and safely surrounded by an adequate treatment margin. Detailed assessment usually includes:

  • Multiparametric prostate MRI
  • Targeted and systematic transperineal biopsies
  • PSA and PSA-density assessment
  • Clinical staging
  • Consideration of PSMA PET/CT in selected men
  • Review of the MRI and pathology at a multidisciplinary meeting

When may ProFocal be unsuitable?

ProFocal would generally not be considered appropriate when there is:

  • Metastatic prostate cancer
  • High-risk or locally advanced disease requiring comprehensive treatment
  • Cancer outside the prostate
  • Extensive cancer involving several areas of the gland
  • Cancer that cannot be reliably identified on MRI
  • A tumour position where an adequate and safe treatment margin cannot be achieved
  • Significant uncertainty about the true extent or grade of the cancer
  • An inability or unwillingness to undergo ongoing MRI scans and repeat biopsies
  • A medical condition that makes anaesthesia or the procedure unacceptably risky

Men with low-risk Grade Group 1 prostate cancer may be better managed with active surveillance, avoiding treatment and its potential complications altogether.

Focal therapy should not be regarded as an easier substitute for appropriate surgery or radiotherapy in men with aggressive, high-volume or advanced prostate cancer.

How is ProFocal treatment performed?

ProFocal is usually performed as a day procedure under general anaesthesia.

Treatment planning

The cancer identified on MRI and biopsy is mapped carefully. The treatment plan includes the visible tumour and an additional safety margin intended to treat microscopic cancer immediately around it.

Placement of the laser applicator

With the patient under anaesthesia, a transrectal ultrasound probe is used to visualise the prostate. A fine laser applicator is inserted through the perineum and positioned within the selected treatment area.

The route is similar to that used for a transperineal prostate biopsy.

Laser ablation

Controlled laser energy heats and destroys the targeted prostate tissue. Temperature monitoring helps the surgeon assess treatment delivery and protect surrounding structures. More than one applicator position may be needed to cover the planned treatment zone.

The published phase II study reported a median treatment time of approximately 60 minutes, although the complete anaesthetic and theatre procedure may take longer.

Recovery

A urinary catheter may be required temporarily because prostate swelling can make urination difficult. Many patients can return home on the day of treatment or after a short admission, depending on their recovery and ability to pass urine.

What are the potential advantages?

The proposed advantages of ProFocal include:

  • Treatment directed at the known cancer rather than the whole prostate
  • No abdominal incision
  • A transperineal, minimally invasive approach
  • Short hospital stay
  • Faster initial recovery than major surgery
  • No ionising radiation
  • Preservation of untreated prostate tissue
  • A potentially lower risk of persistent urinary incontinence
  • A potentially lower risk of erectile dysfunction than whole gland treatment
  • The possibility of further focal or whole-gland treatment if cancer remains or returns

These are potential benefits and should not be interpreted as guarantees.

How does it compare with established alternatives?

There is no mature randomised evidence showing that ProFocal gives the same long-term protection from metastasis or prostate-cancer death as radical prostatectomy or radiotherapy. A balanced consultation should therefore compare all reasonable options:

  • Active surveillance: avoids or delays treatment side effects and is preferred for many men with low-risk disease, but requires PSA testing, MRI and repeat biopsy, with treatment if the cancer progresses.
  • Radical prostatectomy: removes the prostate and provides complete surgical pathology. It has long-term cancer-control data, but carries risks including urinary incontinence, erectile dysfunction, loss of ejaculation and surgical complications.
  • Radiotherapy: has established long-term cancer-control data and avoids surgery, but may cause urinary, bowel and sexual adverse effects; androgen-deprivation therapy may be advised for some risk groups.
  • ProFocal/focal laser ablation: may offer quicker recovery and less short-term urinary or sexual morbidity for carefully selected men, but leaves untreated prostate tissue, requires MRI and repeat-biopsy surveillance, and has uncertain long-term comparative cancer-control outcomes.

The most appropriate option depends on cancer grade, volume and location; PSA and stage; age and general health; baseline urinary and sexual function; personal priorities; and willingness to accept surveillance or treatment uncertainty. A multidisciplinary opinion and, where useful, separate discussions with a urologist and radiation oncologist can reduce treatment-selection bias.

What did the early ProFocal study find?

The first published phase II trial included 100 men with localised, MRI-visible Grade Group 2 or 3 prostate cancer.

At the three-month biopsy:

  • 84% had no clinically significant Grade Group 2 or higher cancer within the treated area
  • Approximately 16% therefore had residual clinically significant cancer within the treatment zone
  • Erectile dysfunction was reported in 12%
  • The average sexual-function scores decreased by approximately 15%
  • Urinary-domain scores decreased by approximately 4.5%
  • No significant deterioration was reported in the other measured functional outcomes

These results are promising, but they represent very early follow-up. The study had no surgery, radiotherapy or active surveillance control group. It therefore cannot establish whether ProFocal provides equivalent long-term protection against recurrence, metastasis or death from prostate cancer.

Possible side effects and complications

Short-term effects may include:

  • Bruising or discomfort in the perineum
  • Blood in the urine
  • Blood in the semen
  • Burning or discomfort when urinating
  • Urinary frequency or urgency
  • Temporary difficulty passing urine
  • Temporary catheterisation
  • Urinary tract infection
  • Pelvic or rectal discomfort
  • Fatigue following anaesthesia

Potential longer-term or less common problems include:

  • New or worsening erectile dysfunction
  • Reduced ejaculatory volume
  • Retrograde ejaculation
  • Urinary incontinence
  • Urethral or bladder-neck scarring
  • Persistent urinary symptoms
  • Damage to tissue outside the intended treatment zone
  • Infection or abscess
  • A fistula involving the urinary tract and rectum, expected to be rare
  • Incomplete cancer treatment
  • Cancer developing or becoming apparent elsewhere in the untreated prostate
  • A requirement for repeat focal therapy, radiotherapy or radical prostatectomy

The risk of sexual or urinary dysfunction depends partly on the size and location of the tumour. A lesion near the neurovascular bundles, urethra, urinary sphincter or bladder neck may be more difficult to treat without affecting function.

The untreated prostate remains important

Prostate cancer is frequently multifocal, meaning that separate areas of cancer may exist within the same prostate. MRI is very useful but cannot detect every small or biologically significant tumour.

ProFocal treats the selected target, not every prostate cell.

This creates two possible patterns of treatment failure:

  1. In-field disease: cancer remains or returns inside the treated area.
  2. Out-of-field disease: cancer is subsequently found elsewhere in the untreated prostate.

A successful early scan does not prove that all clinically significant cancer has been eliminated.

Follow-up after ProFocal therapy

Follow-up is more intensive than simply checking the PSA.

Because the prostate remains in place, PSA will not normally fall to an undetectable level. There is also no universally accepted PSA threshold that defines successful focal treatment or recurrence.

Follow-up may include:

  • Regular PSA testing
  • Clinical review and symptom assessment
  • Multiparametric MRI
  • Quality-of-life and erectile function assessment
  • Repeat targeted biopsy of the treated area
  • Systematic biopsy of the untreated prostate
  • Additional imaging when recurrence is suspected

The Prostate Cancer Foundation of Australia cautions that PSA testing alone is not sufficient to exclude recurrent cancer after focal therapy. Patients must be willing to undergo long-term imaging and, when recommended, further prostate biopsies.

Can treatment be repeated?

Repeat focal treatment may be possible when residual or recurrent cancer remains localised and clearly targetable.

Depending on the findings, subsequent options may include:

  • Repeat focal ablation
  • Radical prostatectomy
  • External-beam radiotherapy
  • Another focal therapy technique
  • Active surveillance for selected low-volume disease
  • Systemic treatment if the cancer has spread

Salvage surgery or radiotherapy may still be possible after focal therapy, but treatment can sometimes be technically more complex because of scarring and tissue changes. The likely salvage options should therefore be discussed before proceeding with ProFocal.

Important limitations

Patients considering ProFocal should understand that:

  • ProFocal is not currently included on the Australian ARTG
  • It is not established as routine standard-of-care treatment
  • Published ProFocal evidence currently comes from a small number of men
  • The pivotal study was single-arm and had very short follow-up
  • Long-term rates of metastasis-free, cancer-specific and overall survival are unknown
  • There are no mature randomised comparisons with prostatectomy, radiotherapy or modern active surveillance
  • Approximately 16% of men in the initial study had clinically significant cancer remaining in the treated area at three months
  • Cancer may be missed elsewhere in the prostate
  • Repeat MRI scans and biopsies are required
  • Further cancer treatment may be needed
  • Access may be limited to trials or special regulatory pathways
  • Medicare or private health insurance may not cover treatment or follow-up costs

What do Australian and international guidance sources say?

The Prostate Cancer Foundation of Australia (PCFA) describes focal therapies as emerging and experimental. It notes that focal treatment may reduce side effects but that the prostate remains in place, PSA monitoring is less straightforward, and ongoing MRI and biopsy are required.

Australian evidence-based resources regard active surveillance, radical prostatectomy and radiotherapy as established pathways for appropriately selected localised disease. ProFocal has not yet acquired the same evidence base or standard-of-care status. The absence of a treatment-specific recommendation should not be reframed as support.

The European Association of Urology (EAU) states that focal therapy has favourable functional outcomes but that definitive evidence of long-term oncological benefit remains unavailable. Its guideline recommends focal HIFU or cryotherapy only within a prospective registry and other ablative methods—including focal laser therapy—only within a well-designed prospective clinical trial.

The American Urological Association and American Society for Radiation Oncology advise clinicians that comparative evidence for focal ablation is lacking and that patients must be informed that further treatment may be required. Focal or whole-gland ablation should not be offered for high-risk prostate cancer outside a clinical trial.

The UK National Institute for Health and Care Excellence (NICE) guidance for focal HIFU and focal cryoablation—not ProFocal specifically—also emphasises special governance, consent, audit/research arrangements and uncertainty about long-term cancer control. This is relevant context for focal therapy but must not be represented as device-specific approval of ProFocal.

The Prostate Cancer Foundation of Australia similarly describes focal therapies as experimental and emphasises the need for continuing MRI, biopsies and careful long-term monitoring.

The bottom line

ProFocal is an Australian-developed investigational technology that may eventually provide selected men with an additional option between surveillance and whole-gland treatment.

Its early results suggest that precisely delivered cooled laser therapy can destroy an MRI-visible prostate cancer target with relatively limited short-term urinary morbidity. However, early cancer clearance is not the same as proven long-term cancer control.

At present, ProFocal should be considered an investigational focal therapy. Consistent with current guidance for focal laser ablation, its most defensible use is within a well-designed prospective clinical trial with ethics and regulatory oversight, multidisciplinary assessment, explicit informed consent, independent outcome reporting and mandatory long-term follow-up.

The decision should be made only after comparing ProFocal with all appropriate alternatives, including active surveillance, radical prostatectomy and radiotherapy.

This article provides general information and does not replace individual medical advice. Regulatory status and treatment availability can change and should be confirmed at the time of consultation.

References and further reading

Benign Prostate Enlargement and Water-Vapour Therapy: A Patient Guide

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Benign prostate enlargement, also called benign prostatic hyperplasia or BPH becomes more common as men age. Enlargement may narrow the urethra, increase resistance to urinary flow and affect the way the bladder stores or empties urine.

Not every enlarged prostate causes symptoms, and not every urinary symptom is caused by the prostate. Treatment should therefore begin with an assessment of the likely cause, the effect on quality of life and whether complications are present.

This article explains BPH and the role of transurethral water-vapour therapy as one of several possible treatments. It does not recommend a particular product, device, clinician or health service.

What symptoms can BPH cause?

Lower urinary tract symptoms may include:

  • a slow or weak urinary stream
  • difficulty starting urination
  • stop–start flow
  • straining to urinate
  • a feeling that the bladder has not emptied
  • passing urine frequently
  • urgency
  • waking at night to urinate
  • dribbling after urination
  • urinary retention

The size of the prostate does not always match symptom severity. A large prostate may cause few problems, while a smaller prostate can obstruct flow because of its shape, a tight bladder neck or a prominent median lobe.

What else can cause urinary symptoms?

Similar symptoms may arise from:

  • urinary tract infection
  • overactive bladder
  • urethral stricture
  • bladder stones
  • impaired bladder-muscle contraction
  • neurological disease
  • prostate or bladder cancer
  • medicines that affect bladder function
  • excessive fluid, caffeine or alcohol intake
  • constipation or sleep disorders

Visible blood in the urine, recurrent infection, kidney impairment, bladder stones, persistent retention or rapidly worsening symptoms require appropriate investigation.

How is BPH assessed?

Assessment may include:

  • a urinary, medical and medication history
  • a validated symptom questionnaire
  • physical examination
  • digital rectal examination
  • urine testing
  • PSA testing after discussion of its benefits and limitations
  • kidney-function testing when indicated
  • urinary flow measurement
  • ultrasound assessment of prostate size and post-void residual urine
  • a bladder diary
  • cystoscopy or urodynamic testing in selected cases

It is particularly important to distinguish bladder-outlet obstruction from weak bladder contraction. Opening the prostate outlet may not restore normal emptying if the bladder muscle is unable to contract adequately.

Does every man with BPH need treatment?

No. Men with mild, non-bothersome symptoms and no complications may choose observation with periodic review.

Conservative measures may include:

  • moderating excessive evening fluid intake
  • reducing caffeine or alcohol when these worsen symptoms
  • treating constipation
  • reviewing relevant medicines
  • avoiding habitual “just in case” voiding where appropriate
  • managing diabetes, sleep apnoea or leg swelling when they contribute to nocturia

Fluid should not be restricted excessively, particularly in hot weather or when dehydration is a risk.

What treatment options are available?

Depending on symptoms, anatomy and risk, options may include:

  • monitoring and lifestyle measures
  • prescription medicines
  • minimally invasive surgical therapies
  • transurethral resection or vaporisation
  • laser enucleation
  • other endoscopic enucleation techniques
  • simple prostatectomy for selected very large glands

Each option differs in speed of improvement, durability, anaesthetic requirements, catheter time, bleeding risk, sexual effects and likelihood of retreatment.

What is transurethral water-vapour therapy?

Water-vapour therapy is a minimally invasive treatment intended to reduce selected areas of benign prostate tissue that are contributing to obstruction.

A specialised instrument is passed through the urethra. A needle delivers controlled water vapour into planned areas of prostate tissue. As the vapour condenses, thermal energy disrupts the targeted cells. The body then gradually reabsorbs treated tissue over the following weeks and months.

Unlike resection or enucleation, obstructing tissue is not physically removed during the procedure. Improvement is therefore delayed while inflammation settles and treated tissue reduces.

The exact device, intended purpose, contraindications and instructions for use should be confirmed from the current Australian Register of Therapeutic Goods entry and manufacturer-approved documentation.

Who might be considered?

Water-vapour therapy may be discussed with selected men whose bothersome symptoms are likely to arise from benign prostate obstruction and who understand the alternatives and likelihood of retreatment.

Assessment may consider:

  • symptom severity and quality-of-life impact
  • prostate volume and shape
  • lateral-lobe or median-lobe obstruction
  • urinary flow and residual urine
  • bladder contractility
  • previous urinary retention
  • coexisting bladder or urethral disease
  • anaesthetic and bleeding risk
  • the importance of preserving ejaculation
  • the patient’s preference regarding recovery, durability and retreatment

The pivotal randomised study enrolled a defined group of men, including prostate volumes between 30 and 80 mL. Evidence outside the studied population is less mature and may rely on observational data.

Larger prostates, catheter-dependent retention or previous prostate procedures do not automatically determine suitability, but the expected results and evidence may differ. A tissue-removing operation may provide more predictable or faster relief in some patients.

When may it be unsuitable?

Reasons to avoid or reconsider water-vapour therapy may include:

  • active urinary infection
  • suspected prostate or bladder cancer requiring investigation
  • urethral stricture preventing safe access
  • poor bladder contractility
  • symptoms caused mainly by overactive bladder rather than obstruction
  • bladder stones or another condition better treated during a different operation
  • anatomy unlikely to be treated adequately
  • severe obstruction or complications requiring rapid, predictable decompression
  • a contraindication in the approved instructions for the proposed device

Suitability must be decided individually. A median lobe is not necessarily an exclusion, but its anatomy and treatment plan require careful assessment.

How is the procedure performed?

The procedure is performed through the urethra, without an external incision. The device is positioned within the prostatic urethra, and treatment is delivered to selected areas according to prostate length, volume and shape.

Anaesthesia and perioperative care vary by patient and facility. The procedure is often performed as day surgery, but same-day discharge is not guaranteed.

Patients should receive individual instructions about:

  • fasting and anaesthesia
  • urine testing
  • antibiotics where clinically indicated
  • anticoagulant and antiplatelet medicines
  • transport and activity after the procedure
  • catheter care
  • symptoms requiring urgent review

Anticoagulant or antiplatelet medicines must not be stopped without advice from the clinician who manages them.

Will a catheter be needed?

Many patients need a temporary urinary catheter because treatment initially causes swelling. Catheter duration varies with prostate anatomy, baseline bladder emptying, pre-existing retention and the clinical course.

Some patients cannot pass urine after the catheter is removed and require reinsertion or intermittent catheterisation. Urgent review is needed if a patient cannot urinate and develops increasing lower-abdominal pain.

When might symptoms improve?

Water-vapour therapy does not usually provide immediate improvement. Urgency, frequency, discomfort or flow may temporarily worsen because of inflammation and swelling.

Improvement may begin over several weeks and continue for several months. The timing and degree of benefit vary, and some patients obtain inadequate relief.

Possible short-term effects

Common or expected effects can include:

  • burning or discomfort when urinating
  • blood in the urine
  • blood or discolouration in the semen
  • urinary frequency or urgency
  • a temporarily weaker stream
  • pelvic or perineal discomfort
  • catheter-related discomfort
  • temporary urinary retention

Patients should follow the written aftercare advice from their treating team.

Other risks and complications

Possible complications include:

  • urinary tract infection
  • prostatitis or systemic infection
  • bleeding
  • persistent urinary retention
  • worsening urgency or incontinence
  • urethral stricture or bladder-neck narrowing
  • ejaculatory change
  • erectile or sexual symptoms
  • chronic pelvic or urinary discomfort
  • failure to improve symptoms
  • need for repeat treatment or another prostate operation

Serious complications are uncommon but possible. Fever, chills, inability to urinate, heavy bleeding, severe pain or feeling systemically unwell require prompt assessment.

What about ejaculation and erections?

Preserving sexual and ejaculatory function is an important goal for many patients considering minimally invasive treatment. Clinical studies have reported relatively low rates of new sexual dysfunction after water-vapour therapy in selected populations.

However:

  • preservation cannot be guaranteed
  • changes in ejaculation can occur
  • erectile function may change for reasons unrelated to the procedure
  • trial definitions and selected participants may not reflect every patient
  • comparison with other procedures depends on technique, anatomy and baseline function

Sexual priorities should be discussed before treatment, along with the more established risk of ejaculatory change after tissue-removing operations.

What did the pivotal five-year study find?

Five-year follow-up from a sham-controlled randomised study reported sustained average improvement in symptoms and urinary flow among study participants who received water-vapour therapy. Reported outcomes included an approximate 48% improvement in symptom score and a 4.4% surgical retreatment rate over five years.

These figures require context:

  • they are group averages, not a prediction for an individual
  • the trial used defined eligibility criteria
  • follow-up does not show what happens over a lifetime
  • some participants did not obtain adequate relief
  • “surgical retreatment” does not capture every medication restart, investigation or non-surgical intervention
  • results may differ with larger prostates, retention, previous surgery or different anatomy

The evidence supports water-vapour therapy as a possible option for selected men; it does not establish it as the best treatment for all men with BPH.

Can the prostate continue to grow?

Yes. The procedure treats selected obstructing tissue present at the time. It does not stop the biological process of benign prostate growth.

Symptoms may remain controlled, recur because of further growth, or persist for another reason such as bladder dysfunction. Younger patients should consider the possibility of needing additional treatment during their lifetime.

How does it compare with tissue-removing surgery?

Water-vapour therapy generally involves less immediate tissue removal and slower improvement than transurethral resection or enucleation.

Potential reasons a patient might consider it include a preference for a less invasive approach and a desire to reduce the chance of ejaculatory change. Potential disadvantages include delayed benefit, postoperative irritation, catheterisation, uncertainty in less-studied anatomies and the possibility of retreatment.

Tissue-removing surgery may be more suitable when there is:

  • severe or recurrent urinary retention
  • very large or complex obstructing anatomy
  • bladder stones
  • recurrent infection caused by poor emptying
  • kidney or upper-tract effects from obstruction
  • substantial bleeding attributable to BPH
  • a need for faster or more predictable relief

No procedure is best for every patient.

Follow-up

Review may assess:

  • urinary symptoms and quality of life
  • urinary flow
  • post-void residual urine
  • infection or retention
  • catheter-related problems
  • sexual or ejaculatory effects
  • need for continuing BPH medicine
  • whether another diagnosis or treatment should be considered

Persistent or worsening symptoms should prompt reassessment rather than repeated reassurance that improvement will eventually occur.

Questions to discuss with a urologist

  • Are my symptoms caused by prostate obstruction?
  • Is my bladder contracting adequately?
  • What is my prostate size and anatomy?
  • Do I have complications that favour a more definitive operation?
  • What are the alternatives, including observation and medicines?
  • How quickly is each option likely to help?
  • What are the risks to ejaculation, erections and continence?
  • How long might I need a catheter?
  • What is the likelihood of needing another procedure?
  • Is the exact proposed device included in the ARTG for this use?
  • What out-of-pocket costs may apply?

Australian regulatory considerations

The Australian Register of Therapeutic Goods (ARTG) records therapeutic goods that may be legally supplied in Australia, unless an exemption or authorised access pathway applies. Inclusion is specific to the sponsor, device and intended purpose; it is not a recommendation that the device is suitable or superior for an individual patient.

Device status, instructions for use, contraindications, reimbursement and availability can change. These should be checked at the time treatment is considered.

The bottom line

BPH is common, but urinary symptoms require assessment because prostate obstruction is only one possible cause.

Transurethral water-vapour therapy is one minimally invasive option for selected men. It may improve urinary symptoms while offering a different balance of recovery, sexual effects and retreatment risk from tissue-removing surgery. Improvement is gradual, catheterisation is common, benefit is not guaranteed and further treatment may be needed.

The choice should follow an informed discussion of observation, medicines, minimally invasive treatments and established surgical options, taking account of prostate anatomy, bladder function, complications and personal priorities.

This article provides general disease education and does not replace individual medical advice. It does not promote or recommend a particular therapeutic device, brand, clinician or health service.

References and further reading

 

Clips for Benign Prostatic Enlargement: A Minimally Invasive Treatment That Preserves Ejaculation

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Benign prostatic hyperplasia, or BPH, is a non-cancerous enlargement of the prostate. As the prostate enlarges, its lateral lobes may compress the urethra and obstruct the flow of urine from the bladder.

Common lower urinary tract symptoms include:

  • A weak or interrupted urinary stream
  • Difficulty starting urination
  • Straining to pass urine
  • Urinary frequency and urgency
  • Getting up repeatedly at night
  • Dribbling after urination
  • A feeling that the bladder has not emptied properly

Medication is usually the first treatment offered to men with troublesome symptoms. However, tablets may provide insufficient relief or cause dizziness, tiredness, reduced libido, erectile problems or altered ejaculation.

The UroLift procedure, also called a prostatic urethral lift or PUL, is a minimally invasive surgical therapy, or MIST, that may provide an alternative to long-term medication and conventional prostate surgery.

What is a MIST procedure?

Minimally invasive surgical therapies are designed to improve urinary symptoms with less tissue damage, less bleeding and a shorter recovery than conventional procedures such as TURP or prostate laser surgery.

Different MIST procedures work in different ways. Some use steam or other forms of energy to destroy prostate tissue. Some temporarily remodel the urinary passage. UroLift mechanically moves the obstructing prostate tissue away from the urethra using small permanent implants.

Its principal attractions are:

  • No cutting or removal of prostate tissue
  • No heat, laser or steam
  • Rapid improvement in many patients
  • Usually brief catheterisation, if any
  • Short recovery
  • A low reported risk of new erectile or ejaculatory dysfunction

The trade-off is that symptom improvement is generally more modest than after a tissue-removing operation, permanent implants remain within the prostate, and some patients will eventually require further treatment.

How does Clips work?

The UroLift system uses small implants to hold the enlarged lateral lobes of the prostate away from the urethra.

Each implant consists of:

  • A small capsular tab placed on the outside of the prostate
  • A stainless-steel urethral end-piece
  • A permanent suture connecting the two components

The implant compresses and retracts the obstructing prostate tissue, widening the urinary channel without cutting, burning or removing tissue.

Most patients require several implants. The exact number depends on the length, size and shape of the prostate and the degree of obstruction. These implants remain permanently in position.

Who may benefit from Clips?

UroLift may be considered for men who:

  • Have moderate or severe urinary symptoms caused by BPH
  • Have obtained inadequate relief from medication
  • Cannot tolerate the side effects of BPH medication
  • Prefer not to take daily medication indefinitely
  • Want a less invasive alternative to TURP or laser surgery
  • Place a high priority on preserving forward ejaculation
  • Want a relatively rapid return to normal activities
  • Have prostate anatomy suitable for a prostatic urethral lift
  • Understand the possibility of future retreatment

It is particularly attractive for sexually active men who wish to improve their urinary symptoms while minimising the risk of dry or retrograde ejaculation.

What prostate size is suitable?

Clinical guidelines and manufacturer labelling are not identical.

Current European Association of Urology guidance recommends offering prostatic urethral lift to men interested in preserving ejaculation who have prostates smaller than 70 mL and no obstructing middle lobe.

American Urological Association guidance supports the procedure for selected men with prostates approximately 30–80 mL and without an obstructing middle lobe.

Manufacturer and regulatory indications may extend to prostates as large as 100 mL and may include selected median-lobe anatomy in some jurisdictions. However, treatment outside the populations best supported by clinical guidelines requires careful patient selection and counselling.

Prostate volume alone does not determine suitability. The shape of the prostate, length of the prostatic urethra, bladder-neck anatomy, degree of obstruction and strength of the bladder muscle must also be considered.

What about an obstructing median lobe?

The median lobe is prostate tissue that projects upwards towards the bladder and may act like a ball valve over the bladder outlet.

UroLift can be used to treat selected obstructing median lobes, and the MedLift study reported encouraging outcomes. Nevertheless, major guideline recommendations remain more conservative because the strongest long-term randomised evidence relates mainly to lateral-lobe obstruction.

A large, mobile or unusually shaped median lobe may be better treated with TURP, laser surgery, Rezūm, Aquablation or another procedure capable of removing or reducing the obstructing tissue.

This is an important anatomical caveat to discuss before choosing UroLift.

Assessment before treatment

Not every urinary symptom is caused by BPH. Infection, urethral stricture, bladder weakness, overactive bladder, neurological disease, medication and prostate or bladder cancer may produce similar symptoms.

Assessment may include:

  • Medical history and examination
  • International Prostate Symptom Score
  • Urine testing
  • PSA testing when appropriate
  • Urinary-flow measurement
  • Ultrasound measurement of residual urine
  • Prostate imaging or ultrasound
  • Flexible cystoscopy
  • Urodynamic testing in selected patients

Cystoscopy may be particularly useful because it allows the urologist to assess the lateral lobes, bladder neck, median lobe and length of the obstructing prostate.

Any urinary infection should be treated before the procedure.

Patients taking aspirin, warfarin, clopidogrel, apixaban, rivaroxaban or other blood-thinning medication require an individual plan. Do not stop blood-thinning medication without instructions from your prescribing doctor and urologist.

How is the UroLift procedure performed?

UroLift is usually performed as a day procedure under local anaesthetic with sedation or a short general anaesthetic.

A cystoscope and specialised delivery device are passed through the urethra. No external incision is required.

The urologist:

  1. Examines the urethra, prostate and bladder.
  2. Positions the delivery device within the prostatic urethra.
  3. Moves the obstructing prostate tissue away from the urinary channel.
  4. Deploys an implant to hold the tissue in its new position.
  5. Repeats the process at selected points until an adequate channel has been created.
  6. Inspects the bladder outlet and controls any bleeding.

The procedure commonly takes less than an hour, although this varies with prostate anatomy and the number of implants required.

Because no prostate tissue is removed, there is usually no specimen for laboratory examination.

Will I need a catheter?

Many men can pass urine after the procedure and go home without a catheter. A catheter may nevertheless be required if there is:

  • Significant prostate swelling
  • Inability to pass urine
  • Pre-existing urinary retention
  • A weak bladder muscle
  • Bleeding or clot formation
  • A high residual urine volume

When required, the catheter is usually temporary. Patients with chronic retention or poor bladder function have a greater risk of failing an early trial without a catheter.

What should I expect after UroLift?

Temporary urinary irritation is common during the first few days.

You may experience:

  • Burning or stinging when passing urine
  • Urinary urgency and frequency
  • Pelvic, perineal or penile discomfort
  • Light blood in the urine
  • Bladder spasms
  • A temporarily weaker or more irregular stream
  • Increased night-time urination
  • A feeling of incomplete emptying

These symptoms generally improve over several days, although urinary irritation may occasionally persist for a few weeks.

Some men notice an improved stream soon after treatment. For others, the benefit develops over the following two to six weeks as swelling and irritation settle.

Managing pain and urinary discomfort

Discomfort after UroLift is usually mild to moderate.

Management may include:

Paracetamol

Paracetamol is commonly sufficient for mild discomfort. Take it according to the instructions provided by your doctor or the directions on the packet.

Avoid accidentally taking additional paracetamol contained in cold, influenza or combination pain medicines.

Anti-inflammatory medication

Ibuprofen or another anti-inflammatory medicine may help when medically appropriate. These medicines may not be suitable for patients with kidney impairment, stomach ulcers, certain heart conditions, bleeding disorders, anti-inflammatory-sensitive asthma or anticoagulant medication.

Check with your doctor or pharmacist before taking an anti-inflammatory medicine.

Medication for urinary symptoms

An alpha blocker may be continued temporarily to assist urine flow while swelling settles. Medication for bladder spasm or urinary burning may occasionally be prescribed.

Practical measures

It may help to:

  • Maintain normal hydration without forcing excessive fluids
  • Limit coffee, tea, alcohol, fizzy drinks and energy drinks
  • Avoid constipation
  • Avoid heavy lifting and vigorous exercise for several days
  • Take pain relief before discomfort becomes severe

Severe or worsening pain should be reported rather than simply tolerated.

Possible complications

Most side effects are mild and temporary, but complications can occur.

Common temporary effects

These include:

  • Pain or burning during urination
  • Blood in the urine
  • Urinary urgency
  • Increased frequency
  • Pelvic discomfort
  • Temporary urinary leakage associated with urgency

Urinary retention

Some men cannot pass urine after the procedure and require temporary catheterisation. The risk may be greater in patients with high residual urine volumes, chronic retention, severe obstruction or a weak bladder muscle.

Urinary tract infection

Infection may cause worsening burning, cloudy or offensive urine, fever, chills or feeling generally unwell. Antibiotics may be required.

Bleeding

Light haematuria is common. Significant bleeding, clot retention or the need for further intervention is uncommon but possible.

Implant-related problems

Potential implant complications include:

  • Incorrect placement
  • Implant exposure within the bladder
  • Encrustation or stone formation
  • Migration or loosening
  • Persistent pelvic discomfort
  • The need to remove an implant
  • Difficulty or irritation during later prostate surgery

Implants placed too close to or within the bladder are more likely to develop encrustation and may require endoscopic removal.

Persistent symptoms

UroLift treats obstruction but does not correct every cause of lower urinary tract symptoms. Urgency, frequency and nocturia may persist when they are caused by bladder overactivity, excessive night-time urine production, sleep apnoea, fluid intake, diabetes or other medical conditions.

Need for further treatment

Some patients obtain insufficient relief or develop recurrent symptoms as the prostate continues to enlarge. Further treatment may involve medication, additional implants, removal of exposed implants or another procedure such as TURP, GreenLight laser, HoLEP, Rezūm or Aquablation.

When should I seek urgent help?

Contact your urologist or attend an emergency department if you:

  • Cannot pass urine
  • Develop fever, shaking or chills
  • Feel generally unwell or confused
  • Pass large blood clots
  • Have heavy or persistent bright-red bleeding
  • Develop severe or increasing pelvic pain
  • Cannot keep fluids down
  • Experience pain that is not controlled by the recommended treatment

Does UroLift affect erections or ejaculation?

Preserving sexual function is one of the main reasons patients choose UroLift.

The pivotal L.I.F.T. study reported no new sustained erectile or ejaculatory dysfunction during five years of follow-up. Because the bladder neck, prostate tissue and ejaculatory pathways are not routinely cut or heated, the risk of retrograde ejaculation is substantially lower than with conventional TURP and many tissue-removing procedures.

However, no treatment can guarantee unchanged erections, sensation, orgasm or ejaculation in every patient.

Men who already have erectile or ejaculatory difficulties should not assume that UroLift will correct those problems. It is primarily a treatment for urinary obstruction.

How effective are Clips?

Clinical studies show meaningful average improvement in:

  • Urinary symptom scores
  • Quality of life
  • Peak urinary-flow rate
  • The patient’s perception of urinary function

Symptoms may improve quickly because the urethra is mechanically opened during the procedure.

However, the average improvement in urinary flow and symptoms is generally less than that achieved with TURP or prostate enucleation. UroLift is therefore best understood as a compromise: less invasive treatment and better preservation of ejaculation in exchange for more modest de-obstruction and a greater chance of later retreatment.

How long do Clips last?

The implants are permanent, but the symptom relief is not necessarily lifelong.

The pivotal L.I.F.T. study demonstrated sustained average improvements for five years. The reported surgical retreatment rate was approximately 13.6% over five years, or roughly 2–3% per year.

Retreatment estimates vary among studies and real-world populations. The need for further treatment may be influenced by:

  • Prostate size and anatomy
  • Median-lobe obstruction
  • Implant position
  • Severity of the original obstruction
  • Bladder function
  • Continued prostate growth
  • The definition of retreatment used in a study

Patients should distinguish between an implant remaining in position and the treatment continuing to control symptoms. A permanent implant does not guarantee permanent symptom relief.

MRI considerations

UroLift implants are classified as MR Conditional, meaning MRI can generally be performed under specified scanner conditions. Patients should tell the radiology service that they have UroLift implants and provide the implant information card whenever possible.

The metallic components can create image artefact, particularly during prostate MRI. This may obscure portions of the prostate and reduce the diagnostic quality of an MRI used to investigate suspected prostate cancer.

This caveat is particularly relevant for:

  • Younger men with a long future need for prostate surveillance
  • Patients with an elevated or rising PSA
  • Men already undergoing prostate cancer monitoring
  • Patients likely to require prostate MRI or targeted biopsy

Appropriate prostate cancer assessment should be completed before UroLift when clinically indicated.

Can prostate surgery still be performed later?

Yes. TURP, laser surgery, HoLEP and other BPH procedures can be performed after UroLift.

However, the surgeon must account for the permanent implants. Clips may be encountered during resection or enucleation, may affect instruments or laser fibres, and may require removal. Some surgeons therefore consider later surgery technically more complex than treatment of an implant-free prostate.

UroLift does not close the door to future treatment, but it does leave permanent material that the future surgeon must manage.

Who should not undergo a Clip procedure?

Manufacturer contraindications include:

  • Active urinary tract infection
  • Current visible or gross haematuria
  • Urinary incontinence caused by an incompetent urinary sphincter
  • A urethral condition that prevents safe insertion of the delivery device
  • A prostate larger than the maximum permitted by the applicable product labelling

UroLift may also be unsuitable or less predictable in men with:

  • Severe chronic urinary retention
  • A poorly contracting bladder
  • Very high residual urine volumes
  • Urethral stricture disease
  • Bladder stones
  • Recurrent urinary infections
  • Significant ongoing bleeding
  • A very high bladder neck
  • A large or unfavourably shaped median lobe
  • A very large prostate
  • Suspected or untreated prostate cancer
  • Symptoms primarily caused by overactive bladder rather than obstruction
  • A need for maximal and durable removal of obstructing tissue

Advantages of Clips

Potential advantages include:

  • Minimally invasive day procedure
  • No prostate tissue removed
  • No laser, heat or steam
  • Rapid relief in many patients
  • Short recovery
  • Catheter often avoided
  • Low reported risk of new erectile dysfunction
  • Low reported risk of dry or retrograde ejaculation
  • Future BPH treatments remain possible

Limitations and important caveats

Patients should understand that:

  • Several permanent implants remain inside the prostate
  • Symptom and flow improvements are usually less than after TURP or enucleation
  • Retreatment is more common than after tissue-removing surgery
  • Not all median lobes are suitable
  • UroLift does not prevent continued prostate growth
  • Urgency and nocturia may persist if they have a bladder or medical cause
  • The implants may reduce the quality of future prostate MRI
  • Later prostate surgery remains possible but may be technically more complicated
  • Prostate cancer should be appropriately assessed before treatment
  • UroLift does not provide prostate tissue for laboratory examination

Are Clips the right option for me?

UroLift can be an excellent option for a carefully selected man who wants meaningful improvement in urinary symptoms, a rapid recovery and a low risk of ejaculatory dysfunction.

It may be less suitable for someone with severe obstruction, chronic retention, weak bladder function, unfavourable median-lobe anatomy or a need for the most powerful and durable improvement possible.

The decision should take account of:

  • Prostate size and shape
  • Presence of a median lobe
  • Severity of symptoms and obstruction
  • Bladder strength and residual urine
  • PSA and prostate cancer risk
  • Previous treatment
  • General health and medication
  • Importance of preserving ejaculation
  • Acceptance of permanent implants
  • Willingness to undergo future retreatment

A urological assessment allows UroLift to be compared fairly with medication, iTind, Rezūm, Aquablation, TURP, GreenLight laser, HoLEP and other appropriate options.

This information is intended for general education and does not replace individual medical advice. Treatment suitability, availability and costs vary. Always follow the instructions provided by your treating urologist.

References

  1. European Association of Urology: Management of non-neurogenic male lower urinary tract symptoms.
  2. American Urological Association: BPH clinical guideline.
  3. Roehrborn CG, et al. Five-year results of the prospective randomised controlled prostatic urethral L.I.F.T. study. Canadian Journal of Urology. 2017;24:8802–8813.
  4. Rukstalis D, et al. Prostatic urethral lift for the treatment of an obstructive median lobe: 12-month results of the MedLift study. Prostate Cancer and Prostatic Diseases. 2019;22:411–419.
  5. UroLift manufacturer safety information.
  6. Benidir T, et al. Impact of the UroLift device on prostate magnetic resonance image quality. Journal of Urology. 2023.