Dutasteride for an Enlarged Prostate: Benefits, Side Effects and When Surgery May Be Better

Benign prostatic hyperplasia—usually called BPH or benign prostate enlargement—is a common cause of urinary symptoms as men get older.

An enlarged prostate can compress the urethra and interfere with bladder emptying, causing symptoms such as:

  • A slow or intermittent urinary stream
  • Difficulty starting urination
  • Straining to urinate
  • A feeling that the bladder has not emptied
  • Urinary frequency or urgency
  • Waking repeatedly at night to urinate
  • Dribbling after urination
  • Episodes of urinary retention

Duodart® combines two established BPH medicines in a single daily capsule. One component relaxes the prostate relatively quickly, while the other gradually reduces its size and lowers the long-term risk of urinary retention and prostate surgery.

Duodart can be very effective in appropriately selected men, but it is not the right treatment for every urinary symptom or every prostate.

What does Dutasteride contain?

Each Duodart capsule contains:

  • Dutasteride 0.5 mg
  • Tamsulosin hydrochloride 0.4 mg

These medicines work in different but complementary ways.

Tamsulosin: relaxing the prostate

Tamsulosin is an alpha-1 adrenergic receptor blocker. It relaxes smooth muscle within the prostate and bladder neck, reducing resistance to urinary flow.

It may improve:

  • Urinary stream
  • Hesitancy
  • Straining
  • Bladder emptying
  • Some frequency and urgency symptoms

Improvement may begin within days, although the full response can take several weeks.

Tamsulosin improves urinary symptoms but does not substantially reduce prostate size or prevent long-term prostate growth.

Dutasteride: gradually shrinking the prostate

Dutasteride is a 5-alpha-reductase inhibitor—5-ARI. It blocks both type 1 and type 2 forms of the enzyme that converts testosterone into dihydrotestosterone—DHT.

DHT is an important driver of prostate growth. Reducing DHT gradually causes susceptible prostate tissue to shrink.

According to the European Association of Urology, 5-ARIs can:

  • Reduce prostate volume by approximately 18–28%
  • Improve urinary symptom scores by approximately 15–30%
  • Reduce PSA by approximately 50% after six to twelve months
  • Reduce the long-term risk of acute urinary retention
  • Reduce the likelihood of requiring BPH surgery

The dutasteride component works slowly. A meaningful benefit may take three to six months, with further improvement occurring over several years.

Who may benefit from Duodart?

Duodart is most appropriate for men with moderate-to-severe urinary symptoms caused by an enlarged prostate who also have an increased risk of BPH progression.

It may be considered when there is:

  • A prostate volume of approximately 40 mL or greater
  • A clearly enlarged prostate on examination or ultrasound
  • An elevated PSA consistent with benign prostate enlargement
  • A reduced urinary flow rate
  • An increased post-void residual urine volume
  • Increasing symptoms despite alpha-blocker treatment
  • A risk of future urinary retention
  • A desire to reduce the likelihood of BPH-related surgery
  • A need for both relatively rapid symptom relief and long-term reduction in prostate size

Some men with prostates between 30 and 40 mL may also benefit, depending on their PSA, symptoms, urinary flow and other risk factors.

Combination treatment is generally intended for long-term use rather than a short trial lasting only a few weeks.

Who may not benefit?

Duodart is less likely to help when:

  • The prostate is small
  • Symptoms are primarily caused by an overactive bladder
  • There is poor bladder-muscle contraction
  • A urethral stricture is present
  • Prostate or bladder cancer is causing the obstruction
  • A bladder stone is responsible for the symptoms
  • Neurological bladder dysfunction is present
  • Symptoms are mild and not troublesome

A large prostate and severe symptoms do not always occur together. Some men with a very large prostate urinate reasonably well, while others with a small prostate have significant obstruction from a tight bladder neck, urethral narrowing or abnormal prostate shape.

This is why treatment should be based on an assessment rather than prostate size alone.

What assessment is recommended before starting Duodart?

Depending on the patient, assessment may include:

  • A detailed urinary and medication history
  • International Prostate Symptom Score—IPSS
  • Physical examination
  • Digital rectal examination
  • Urine testing
  • PSA testing
  • Kidney-function blood tests
  • Urinary flow-rate measurement
  • Ultrasound measurement of prostate size
  • Post-void residual urine measurement
  • A bladder diary when frequency or nocturia is prominent
  • Cystoscopy or urodynamic testing in selected patients

Prostate cancer and other important causes of urinary obstruction should be considered before symptoms are attributed to BPH.

How is Duodart taken?

The usual dose is one capsule once daily, taken approximately 30 minutes after the same meal each day.

The capsule should be swallowed whole. It should not be opened, crushed or chewed because its contents may irritate the mouth and throat.

Taking the capsule consistently after the same meal helps maintain predictable absorption of tamsulosin.

If treatment is stopped, urinary symptoms and prostate growth may gradually return. Duodart should not be stopped or restarted without discussing this with the prescribing doctor.

What benefits can be expected?

Tamsulosin provides the earlier benefit by relaxing the prostate and bladder neck. Dutasteride provides the slower, longer-term benefit by reducing prostate volume and the risk of progression.

In long-term clinical studies, dutasteride plus tamsulosin produced greater improvement in urinary symptoms and urinary flow than either medicine alone in appropriately selected men.

The EAU reports that, compared with tamsulosin alone at four years, combination treatment reduced the relative risk of:

  • Acute urinary retention by approximately 68%
  • BPH-related surgery by approximately 71%
  • Symptom deterioration by approximately 41%

These are relative reductions from clinical-trial populations. The individual absolute benefit depends on the patient’s original risk, prostate size, PSA and degree of obstruction.

Duodart controls BPH; it does not permanently cure it.

Common side effects

Because Duodart contains two medicines, it can cause side effects associated with either component.

Ejaculatory changes

Tamsulosin can interfere with ejaculation. Patients may notice:

  • Reduced semen volume
  • Dry ejaculation
  • Failure to ejaculate
  • Semen passing backwards into the bladder—retrograde ejaculation

This is usually harmless but can affect sexual satisfaction and fertility.

Combination treatment has a higher risk of ejaculatory dysfunction than either an alpha blocker or 5-ARI used alone.

Reduced sexual desire

Dutasteride reduces DHT and may cause a decrease in libido. The effect may be mild for some men but troubling for others.

Erectile dysfunction

Difficulty achieving or maintaining an erection can occur. BPH itself, increasing age, vascular disease, diabetes and other medications can also contribute, so the cause is not always straightforward.

Breast changes

Dutasteride can occasionally cause:

  • Breast tenderness
  • Nipple sensitivity
  • Breast enlargement—gynaecomastia

A breast lump, nipple discharge or persistent one-sided change should be assessed promptly rather than assumed to be a medication effect.

Dizziness and low blood pressure

Tamsulosin may lower blood pressure, particularly when standing. This can cause:

  • Dizziness
  • Light-headedness
  • Weakness
  • Fainting
  • An increased risk of falling

Extra care is needed when treatment begins, after a dose change or when Duodart is combined with other blood-pressure-lowering medicines.

Other possible side effects

Other reported effects include:

  • Headache
  • Tiredness
  • Palpitations
  • Nasal congestion
  • Gastrointestinal discomfort
  • Skin rash or itching
  • Testicular discomfort or swelling
  • Mood changes or depression
  • Reduced fertility or changes in semen quality

Semen-volume and sperm changes do not necessarily cause infertility, but men planning a pregnancy should discuss this before treatment.

Rare but important reactions

Urgent medical assistance is required for:

  • Swelling of the face, tongue or throat
  • Difficulty breathing
  • A severe allergic reaction
  • Fainting
  • A painful erection lasting several hours—priapism
  • Severe blistering or peeling skin
  • Marked depression or suicidal thoughts

These reactions are uncommon but require prompt assessment.

Duodart and cataract surgery

Tamsulosin is associated with intraoperative floppy iris syndrome, which can make cataract or glaucoma surgery more difficult.

Patients should tell their ophthalmologist if they:

  • Currently take Duodart
  • Previously took Duodart
  • Previously used another medicine containing tamsulosin

Stopping tamsulosin shortly before surgery may not completely remove this risk. The decision should be made between the ophthalmologist and prescribing doctor rather than by the patient alone.

Contraindications and important precautions

Duodart should not be used in:

  • Women
  • Children or adolescents
  • Anyone allergic to dutasteride, tamsulosin, another 5-ARI or a capsule ingredient
  • Patients with a history of significant postural or orthostatic hypotension
  • Patients with severe liver impairment

Additional caution is required in men with:

  • Recurrent dizziness or falls
  • Significant cardiovascular disease
  • Liver disease
  • Severe kidney impairment
  • Planned cataract or glaucoma surgery
  • A history of depression or major mood disturbance
  • Suspected prostate cancer
  • Severe urinary retention
  • A very high post-void residual urine volume
  • Other medicines that substantially lower blood pressure

Duodart changes the interpretation of PSA

Dutasteride generally lowers PSA by approximately 50% after six to twelve months.

This does not mean that prostate cancer risk has disappeared. A new PSA baseline should be established after treatment begins, and subsequent results must be interpreted in the context of dutasteride use.

A confirmed rise from the lowest PSA reached while taking Duodart may require investigation—even when the result remains within the laboratory’s usual “normal” range.

Patients should tell any doctor ordering or interpreting a PSA test that they are taking dutasteride.

PSA monitoring and appropriate prostate cancer assessment should continue while using Duodart.

What is “post-finasteride syndrome”?

“Post-finasteride syndrome” is a term used to describe persistent symptoms reported by some patients during or after stopping finasteride.

Reported symptoms have included:

  • Reduced libido
  • Erectile dysfunction
  • Altered genital sensation
  • Ejaculatory or orgasmic changes
  • Fatigue
  • Poor concentration or “brain fog”
  • Anxiety
  • Depressed mood
  • Sleep disturbance

The existence, frequency, biological mechanism and diagnostic criteria of post-finasteride syndrome remain debated. Some patients report very real and persistent symptoms, but current research has not established a reliable way to predict who may be affected or to prove that every reported symptom is directly caused by the medicine.

It should therefore neither be presented as a guaranteed consequence nor dismissed when a patient reports persistent symptoms.

Is post-finasteride syndrome relevant to Duodart?

Duodart does not contain finasteride. It contains dutasteride.

However, finasteride and dutasteride belong to the same 5-ARI medicine class and both reduce DHT. Sexual side effects such as reduced libido, erectile dysfunction and ejaculatory changes are recognised with both medicines.

Dutasteride inhibits both type 1 and type 2 5-alpha-reductase and remains in the body much longer than finasteride. Its terminal half-life is approximately five weeks, so adverse effects may not disappear immediately after stopping treatment.

Persistent sexual symptoms have been reported after treatment with 5-ARIs, although the frequency and causal relationship remain uncertain.

A 2025 European Medicines Agency safety review found insufficient evidence to establish a causal association between dutasteride and suicidal thoughts. Nevertheless, because of a possible class effect, the EMA recommended precautionary information about mood changes for dutasteride products.

Patients taking Duodart should contact their doctor if they develop:

  • New or worsening sexual dysfunction
  • Persistent loss of libido
  • Depressed mood
  • Significant anxiety
  • Suicidal thoughts
  • Symptoms that continue after stopping treatment

Stopping Duodart suddenly may allow urinary obstruction to worsen, so medication changes should usually be supervised. Suicidal thoughts or severe psychological distress require urgent assistance.

Monitoring treatment

Patients should usually be reviewed after starting Duodart to assess:

  • Improvement in urinary symptoms
  • Dizziness or postural blood-pressure changes
  • Sexual and ejaculatory function
  • Mood changes
  • Urinary flow rate
  • Post-void residual urine
  • PSA response
  • Kidney function when clinically indicated

The tamsulosin component should produce an earlier response, while the dutasteride benefit is judged over several months.

A lack of rapid improvement does not necessarily mean dutasteride has failed. Conversely, ongoing severe symptoms should not automatically be managed by continuing the medication indefinitely without reassessment.

When should surgery be considered?

Medication is often the first treatment for uncomplicated BPH, but surgery should not be regarded merely as a last resort. For some patients it offers more reliable relief and prevents further bladder or kidney damage.

Surgery should be considered when there is:

  • Recurrent or persistent urinary retention
  • Dependence on a urinary catheter
  • Recurrent urinary tract infections caused by poor emptying
  • Bladder stones
  • Recurrent visible bleeding attributable to BPH
  • Overflow urinary incontinence
  • Progressive bladder diverticula associated with obstruction
  • Dilatation of the kidneys or ureters
  • Kidney impairment caused by bladder outlet obstruction
  • A very high or increasing residual urine volume
  • Persistent bothersome symptoms despite adequate medication
  • Intolerable medication side effects
  • A preference for a procedural solution rather than lifelong tablets
  • Poor urinary flow with objective evidence of significant obstruction

Earlier surgery may also be appropriate when obstruction is beginning to damage bladder function. Waiting until the bladder has become severely stretched or weak can reduce the improvement achievable after surgery.

When is Duodart unlikely to prevent surgery?

Surgery may still be needed when:

  • The prostate obstruction is mechanically severe
  • A large middle lobe acts like a ball valve at the bladder outlet
  • Urinary retention has already occurred repeatedly
  • Bladder stones or recurrent infections are present
  • Residual urine continues to increase
  • Kidney function or upper urinary tract drainage is affected
  • Symptoms remain troublesome after an adequate trial
  • The bladder has become poorly contractile
  • Side effects make long-term treatment unacceptable

Duodart can reduce future risk; it cannot reliably reverse every established complication of obstruction.

What surgical options are available?

The appropriate procedure depends on prostate size, prostate shape, bleeding risk, bladder function, general health and the importance of preserving ejaculation.

Options may include:

  • Transurethral resection of the prostate—TURP
  • GreenLight laser prostate vaporisation
  • Holmium laser enucleation—HoLEP
  • Rezūm water-vapour therapy
  • UroLift
  • Temporary implantable nitinol device—iTind
  • Robotic or open simple prostatectomy for very large glands
  • Other enucleation or minimally invasive techniques

Some minimally invasive treatments are best suited to selected prostate sizes and shapes. Not every option provides the same durability, improvement in urinary flow or preservation of ejaculation.

The bottom line

Duodart combines the relatively quick muscle-relaxing effect of tamsulosin with the slower prostate-shrinking and progression-reducing effect of dutasteride.

It is most useful for men with moderate-to-severe urinary symptoms, a genuinely enlarged prostate and a meaningful risk of future urinary retention or surgery.

Sexual and ejaculatory side effects, dizziness, breast changes and possible mood effects should be discussed before treatment. Duodart also lowers PSA, so ongoing prostate cancer surveillance must be interpreted differently.

The term “post-finasteride syndrome” remains scientifically debated. Duodart does not contain finasteride, but dutasteride acts on the same hormonal pathway, and persistent symptoms reported by a patient deserve careful assessment.

Medication should not be continued indefinitely when symptoms remain severe, complications develop or bladder and kidney function are threatened. In those circumstances, timely prostate surgery may be safer and more effective than simply adding another tablet.

This article provides general information and does not replace personalised medical advice. Patients should not start, stop or alter Duodart without consulting their treating doctor.

So, if you are having difficulty with your lower urinary tract symptoms and you wish to remain conservative in your management and not to fussed about your erectile function and libido, come see your local Brisbane urologist, dr Jo Schoeman, to discuss further options

References and further reading

ProFocal® Therapy for Prostate Cancer: Targeting the Cancer While Preserving the Prostate

For many years, treatment for localised prostate cancer has involved either monitoring the whole prostate or treating the entire gland with surgery or radiotherapy. ProFocal® therapy represents a newer approach: using precisely delivered 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 aim is to achieve cancer control while reducing the risk of urinary incontinence, erectile dysfunction and other complications associated with whole-gland treatment.

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 an approved clinical trial or a specific TGA access pathway, such as use by an appropriately authorised prescriber. For example, an Australian clinical trial investigating ProFocal for prostate cancer recurring after radiotherapy specifies that treatment is being provided by surgeons with TGA Authorised Prescriber approval.

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.

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.

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 international urological guidelines say?

The European Association of Urology states that focal therapy has favourable functional outcomes, but definitive evidence of long-term oncological benefit remains unavailable. Its 2026 guideline recommends that focal HIFU or cryotherapy be undertaken within a prospective registry and that other ablative methods—including focal laser therapy—be offered 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 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 exciting Australian-developed technology that may eventually provide selected men with a middle path between active 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, ideally undertaken within a properly governed clinical trial with multidisciplinary assessment, informed consent 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

So, if this is what you are interested in having for your localized prostate cancer, come chat to your local Brisbane urologist, Dr Jo, to discuss this option.

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

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 UroLift 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 UroLift?

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 is UroLift?

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 does UroLift 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 UroLift?

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 UroLift

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

Is UroLift 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.

If you are troubled by lower urinary tract symptoms but are not yet ready to farewell your forward ejaculation, come and see your Brisbane urologist, Dr Jo, Uro-Jo, to discuss whether UroLift may be an appropriate option for your BPH.

iTind for Benign Prostatic Enlargement: Temporary Treatment Without a Permanent Implant

Benign prostatic hyperplasia—or BPH—is a non-cancerous enlargement of the prostate. As the prostate grows, it may compress the urethra and interfere with emptying the bladder.

Typical symptoms include:

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

Medication is often the first treatment. However, tablets do not help every patient and may cause dizziness, tiredness, reduced ejaculation, erectile difficulties or reduced libido. The iTind procedure offers selected men a minimally invasive alternative to long-term medication or conventional prostate surgery.

What is iTind?

The iTind is a small temporary device made from nitinol, a flexible nickel–titanium alloy with “shape memory.”

It is sometimes called a temporary prostatic stent, although it differs from a traditional stent because it is not intended to remain permanently within the prostate. The device is left in place for only five to seven days and is then removed completely.

While in position, three expanding struts apply controlled pressure to specific areas of the prostate and bladder neck. This remodels the prostatic urethra and creates channels through which urine can flow more easily.

The procedure does not:

  • Permanently implant metal within the prostate
  • Remove prostate tissue
  • Use laser, heat or steam
  • Prevent future prostate treatments if symptoms return

Who may benefit from iTind?

iTind may be considered for men who have bothersome urinary symptoms caused by BPH and who:

  • Have obtained insufficient benefit from medication
  • Have developed side effects from BPH tablets
  • Prefer not to take daily medication indefinitely
  • Want a less invasive alternative to TURP or laser surgery
  • Wish to minimise the risk of ejaculatory or erectile side effects
  • Prefer not to have a permanent prostatic implant
  • Have prostate size and anatomy suitable for the device

The procedure is generally best suited to men with moderate-to-severe symptoms and a prostate measuring approximately 25–75 mL, without a significantly obstructing median lobe.

These measurements are a guide rather than a guarantee of suitability. The shape of the prostate, severity of obstruction and function of the bladder are as important as prostate size.

Assessment before treatment

Urinary symptoms are not always caused by an enlarged prostate. Similar problems can result from infection, urethral narrowing, bladder weakness, an overactive bladder, neurological disease, medication or, less commonly, cancer.

Assessment may therefore include:

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

Any urinary infection should be treated before the procedure.

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

How is the iTind procedure performed?

Insertion

The folded iTind device is passed through the urethra using a small cystoscope. It is positioned in the prostatic urethra immediately below the bladder neck and then released.

The procedure is usually performed as day surgery. Depending on the patient and treatment setting, local anaesthetic, intravenous sedation or a short general anaesthetic may be used.

A soft retrieval string remains attached to the device and passes out through the urethra. It is usually secured to the penis until the device is removed.

Most patients can return home on the same day without a urinary catheter. Occasionally, temporary catheterisation is necessary if the patient is unable to pass urine.

The treatment period

The device remains inside the prostate for five to seven days. Its struts gradually apply pressure to the prostate and bladder neck, creating three longitudinal channels within the urinary passage.

Patients remain at home during this treatment period.

Removal

The device must be removed after five to seven days. It is collapsed into a soft catheter and withdrawn in one piece, usually during a brief outpatient visit.

Local anaesthetic gel is often sufficient, although additional pain relief or sedation may be offered when appropriate. No metal or permanent implant remains inside the prostate after removal.

What should I expect while the device is in place?

The five-to-seven-day treatment period is generally the most uncomfortable part of the process. Common temporary symptoms include:

  • Pelvic or perineal pressure
  • Burning or stinging when passing urine
  • Urinary urgency and frequency
  • Discomfort at the tip of the penis
  • Bladder spasms
  • Light bleeding in the urine
  • Interrupted sleep
  • Awareness of the retrieval string
  • A temporarily weak or irregular urinary stream

These symptoms are usually mild to moderate and commonly improve soon after the device is removed.

Patients should generally avoid heavy lifting, vigorous exercise, cycling and sexual activity while the device and retrieval string are in place. Follow the particular instructions provided by your urologist.

The retrieval string should not be pulled, cut, repositioned or removed by the patient.

How can pain and discomfort be managed?

Pain varies considerably between patients. Some men experience only mild pressure, while others find urinary urgency, bladder spasm or discomfort from the retrieval string more troublesome.

A pain-management plan may include the following measures.

Paracetamol

Paracetamol is usually the first choice for mild-to-moderate discomfort. Take it according to your doctor’s instructions or the directions on the packet.

Check cold, influenza and combination pain medicines carefully, as these may also contain paracetamol. Do not exceed the recommended daily dose.

Patients with significant liver disease or heavy alcohol consumption should discuss paracetamol use with their doctor.

Anti-inflammatory medication

An anti-inflammatory medicine such as ibuprofen may help reduce pain and inflammation when medically appropriate.

These medications may not be suitable for patients with:

  • Kidney impairment
  • Stomach ulcers or gastrointestinal bleeding
  • Heart failure or certain cardiovascular conditions
  • Asthma triggered by anti-inflammatory medication
  • Bleeding disorders
  • Anticoagulant or antiplatelet treatment

Check with your urologist, general practitioner or pharmacist before taking an anti-inflammatory medication.

Medication for bladder irritation

An alpha blocker may occasionally be continued or prescribed temporarily to help urine flow. A bladder-calming medication may be considered if urgency or bladder spasms are particularly troublesome.

These medicines are not necessary for every patient and have their own potential side effects.

Practical measures

It may also help to:

  • Maintain normal hydration without forcing excessive fluids
  • Reduce coffee, tea, cola drinks, alcohol and energy drinks
  • Avoid constipation
  • Wear loose, supportive underwear
  • Avoid heavy lifting and strenuous exercise
  • Take pain relief early rather than waiting until discomfort becomes severe

Strong opioid medication is not usually required. It may worsen constipation and, in susceptible patients, contribute to difficulty emptying the bladder.

Severe or increasing pain is not considered something that should simply be tolerated. Contact the treating practice if the discomfort is not controlled by the recommended measures.

What happens after removal?

Burning, urinary urgency and light bleeding may continue briefly after the device is removed, but these symptoms should progressively improve.

Some patients notice an improvement in their stream soon after removal. For others, improvement develops more gradually over several weeks as irritation settles and the remodelled urinary channels stabilise.

Many patients return to normal daily activities within a few days. Your urologist will advise when you may resume strenuous exercise and sexual activity.

Follow-up may include:

  • Review of urinary symptoms
  • Repeat symptom scoring
  • A urinary-flow test
  • Measurement of residual urine
  • Discussion about continuing or stopping BPH medication

Do not stop established prostate medication unless advised to do so.

Side effects and possible complications

Most side effects are temporary and occur while the device is in place. Reported problems include:

  • Burning during urination
  • Urinary frequency and urgency
  • Pelvic discomfort or pain
  • Blood in the urine
  • Temporary difficulty passing urine
  • Urinary tract infection
  • Bladder spasm
  • Movement or incorrect positioning of the device
  • Temporary catheterisation
  • Failure to obtain sufficient symptom relief

Published studies report different complication rates, but most events have been mild and self-limiting. Temporary haematuria, dysuria, urgency and pelvic discomfort are the most frequently reported problems.

Acute urinary retention, urinary infection or significant bleeding are less common but important complications.

When should I seek urgent medical attention?

Contact your urologist or attend an emergency department if you:

  • Cannot pass urine
  • Develop fever, shaking or chills
  • Feel generally unwell or confused
  • Develop severe or increasing pelvic pain
  • Pass large blood clots
  • Have heavy or persistent bright-red bleeding
  • Cannot keep fluids down
  • Notice that the retrieval string or device has moved
  • Develop pain that is not controlled by the agreed treatment plan

Does iTind affect erections or ejaculation?

One of the principal attractions of iTind is its favourable sexual side-effect profile.

Clinical studies have reported preservation of erectile and ejaculatory function in most treated patients. This contrasts with tissue-removing prostate procedures, which may carry a significant risk of retrograde or absent ejaculation.

Nevertheless, no treatment can guarantee that sexual or ejaculatory function will remain unchanged in every patient.

How effective is iTind?

Studies have demonstrated average improvements in:

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

The improvement may be less dramatic than that achieved with a tissue-removing operation such as TURP or laser enucleation. The advantage is that iTind is less invasive, usually requires little recovery time and has a low reported risk of sexual side effects.

It is therefore best viewed as a balance between symptom improvement and treatment invasiveness.

How long does the benefit last?

Although the implant remains in place for only five to seven days, the channels produced within the prostate may remain open for several years.

Prospective studies have demonstrated sustained benefit for more than four years in some appropriately selected patients. This does not mean that iTind is guaranteed to last for four years—or that it will provide lifelong relief.

BPH may continue to progress as a man ages. Some patients will eventually need to restart medication or undergo another procedure. Longer-term evidence for iTind remains more limited than that available for established procedures such as TURP or laser enucleation.

Because nothing is left permanently inside the prostate, iTind does not generally prevent later treatment. Options may include medication, another minimally invasive procedure, TURP, GreenLight laser treatment, HoLEP or another form of prostate surgery.

Who should not undergo iTind?

Contraindications described in the manufacturer’s information include:

  • Active urinary tract infection
  • Acute prostatitis
  • Known prostate cancer
  • Known bladder cancer
  • An artificial urinary sphincter or another implant within the urethra
  • Bladder atonia or a non-contractile bladder
  • Neurogenic bladder dysfunction
  • Urinary obstruction caused by a urethral stricture or something other than BPH

The procedure may also be unsuitable or less predictable in men with:

  • A significantly obstructing median prostatic lobe
  • A prostate outside the best-studied size range
  • Severe chronic urinary retention
  • Very high residual urine volumes
  • Recurrent urinary infections
  • Bladder stones
  • Significant ongoing haematuria
  • Advanced bladder weakness
  • A need for rapid and substantial removal of obstructing tissue
  • Anatomy that prevents safe cystoscopic access

Previous prostate surgery, urethral surgery, nickel sensitivity and blood-thinning medication require individual consideration.

Patients with obstruction causing kidney impairment, repeated retention, recurrent infections, bladder stones or significant bleeding may receive more reliable relief from a definitive tissue-removing procedure.

Advantages of iTind

Potential advantages include:

  • Minimally invasive day procedure
  • No cutting, laser, steam or thermal energy
  • No permanent implant
  • Usually no postoperative catheter
  • Rapid return to ordinary activities
  • Low reported risk of new erectile dysfunction
  • Low reported risk of ejaculatory dysfunction
  • Does not usually compromise future BPH treatment

Limitations of iTind

Potential limitations include:

  • Discomfort during the treatment week
  • A retrieval string for five to seven days
  • A second procedure to remove the device
  • Not suitable for every prostate shape or size
  • Less improvement than some tissue-removing procedures
  • Possibility of persistent or recurrent symptoms
  • Potential need for future medication or surgery
  • Less very-long-term evidence than TURP or laser enucleation

Is iTind the right treatment for me?

iTind is not simply a smaller version of TURP. It offers a different compromise: a less invasive procedure with no permanent implant and a favourable sexual side-effect profile, but generally more modest improvement and less long-term evidence than tissue-removing surgery.

The best treatment depends on:

  • The severity of your symptoms
  • The size and shape of your prostate
  • The amount of urinary obstruction
  • Bladder strength and residual urine
  • Previous treatment
  • General health and medication
  • The importance of preserving ejaculation
  • Your willingness to accept possible future retreatment

A urological assessment is essential to confirm that BPH is responsible for the symptoms and to compare iTind fairly with medication, Rezūm, UroLift, TURP, GreenLight laser, HoLEP and other appropriate treatments.

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. Sandhu JS, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2023. Journal of Urology. 2024.
  2. Chughtai B, et al. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicentre, Randomised, Controlled Trial. Urology. 2021;153:270–276.
  3. Kadner G, et al. Second generation of temporary implantable nitinol device in men with lower urinary tract symptoms: two-year results of the MT-02 study. World Journal of Urology. 2020;38:3235–3244.
  4. Amparore D, et al. Three-year results following treatment with the second-generation temporary implantable nitinol device. Prostate Cancer and Prostatic Diseases. 2021;24:349–357.
  5. Amparore D, et al. Temporary implantable nitinol device for BPH-related lower urinary tract symptoms: over 48-month results. Minerva Urology and Nephrology. 2023;75:743–751.
  6. NICE: iTind for lower urinary tract symptoms caused by BPH.
  7. Olympus: iTind clinical and procedural information.

So, if you are experiencing LUTS, lower urinary tract symptoms, and you are not yet ready to farewell your prograde ejaculation function, come see your Brisbane urologist, Dr Jo, Uro-Jo and discuss this option for your BPH.

Barrigel® Rectal Spacer During Prostate Cancer Radiation Therapy

Creating a temporary safety zone between the prostate and rectum

Radiation therapy is an effective treatment for many men with prostate cancer. Modern radiation techniques are remarkably accurate, but there is one anatomical challenge: the prostate sits immediately in front of the rectum.

This means that while radiation is directed at the prostate, part of the rectum may also receive radiation.

One approach to reducing this exposure is to temporarily create a small space between the prostate and rectum before radiation treatment begins.

Barrigel® is a biodegradable hyaluronic acid rectal spacer designed specifically for this purpose.


Why does the rectum need protection?

The prostate and rectum normally sit almost against each other, separated by only a thin layer of tissue.

During prostate radiation therapy, some radiation therefore inevitably reaches the anterior wall of the rectum.

This can contribute to bowel symptoms such as:

  • increased bowel frequency
  • urgency
  • loose stools or diarrhoea
  • rectal discomfort
  • mucus discharge
  • rectal bleeding
  • radiation proctitis

Most bowel symptoms following modern radiation therapy are mild and temporary, but occasionally they can persist or become troublesome.

The basic idea behind a rectal spacer is delightfully simple:

Prostate → spacer → rectum

Instead of asking radiation technology to perform an anatomical magic trick, we physically move the rectum a little farther away.

Even approximately 1 cm of additional separation can substantially reduce the radiation dose received by the anterior rectal wall.


What is Barrigel?

Barrigel is a sterile, biodegradable gel made from stabilised, non-animal-derived hyaluronic acid.

Hyaluronic acid occurs naturally in many tissues within the human body and is widely used in medical applications.

Barrigel is injected into the tissue plane between the prostate and anterior rectal wall before prostate radiation therapy.

The gel creates a temporary cushion that pushes the rectum away from the prostate.

Importantly, Barrigel does not treat the prostate cancer itself.

Its purpose is to protect surrounding normal tissue while radiation treats the cancer.


How is Barrigel inserted?

Barrigel is usually inserted before radiation planning.

The procedure is performed using ultrasound guidance.

A needle is passed through the skin of the perineum, the area between the scrotum and anus, rather than through the rectum.

The needle is carefully positioned between the back of the prostate and the front wall of the rectum.

Barrigel is then slowly injected while the position of the gel is continuously monitored with ultrasound.

Typically several millilitres of gel are used to create the required separation.

The procedure may be performed using:

  • local anaesthetic
  • sedation
  • or another form of anaesthesia depending upon the patient and treating centre.

Fiducial markers used for radiation targeting may sometimes be inserted during the same procedure.

Antibiotic prophylaxis and strict sterile technique are important.


Who may benefit from Barrigel?

Barrigel may be considered for men undergoing radiation therapy for localised prostate cancer where reducing radiation exposure to the rectum is desirable.

This may include men undergoing:

Conventional external-beam radiation therapy

A spacer may reduce the amount of radiation reaching the rectum during a multi-week course of treatment.

Hypofractionated radiation therapy

Modern prostate radiation is increasingly delivered using larger doses over fewer treatment sessions.

A randomised clinical trial involving 201 men demonstrated that a hyaluronic-acid spacer significantly reduced rectal radiation exposure during hypofractionated prostate radiotherapy.

Acute grade 2 or greater gastrointestinal side effects occurred in approximately 2.9% of spacer-treated patients compared with 13.8% without a spacer.

Stereotactic body radiation therapy – SBRT

SBRT delivers relatively high radiation doses over only a few treatments. Precise protection of surrounding structures therefore becomes particularly important.

Selected salvage radiation situations

Spacer placement may occasionally be considered in more complex circumstances, although previous prostate or pelvic treatment can alter the normal tissue planes and make insertion more difficult.

These cases require individual assessment by the radiation oncologist and urologist.


When should Barrigel not be used?

Barrigel is contraindicated in patients with clinical T4 prostate cancer.

It should also be approached cautiously in men with conditions that may make insertion difficult or increase the risk of complications.

These include:

  • active infection or inflammation near the injection site
  • bleeding disorders
  • anticoagulant or thrombolytic therapy
  • significant antiplatelet medication
  • known allergy to hyaluronic-acid products
  • significant anorectal stenosis or anatomical abnormalities
  • previous surgery causing extensive scarring around the prostate or rectum
  • significant haemorrhoidal disease
  • immunodeficiency or significant immunosuppressive therapy.

Anticoagulant and antiplatelet medications should not simply be stopped without medical advice. Their management needs to be individualised according to the reason they are being taken.


What are the potential side effects?

Most patients tolerate spacer insertion well.

Temporary symptoms may include:

  • discomfort in the perineum
  • minor bleeding or bruising
  • a sensation of rectal fullness
  • temporary discomfort when opening the bowels
  • urinary frequency or discomfort
  • weak urinary stream
  • temporary constipation.

The feeling that there is “something there” behind the prostate can occur initially and generally settles.


What are the uncommon but important complications?

Although rectal spacer insertion is generally considered a low-risk procedure, it is still an invasive procedure.

Possible complications include:

  • infection
  • prostatitis
  • bleeding or haematoma
  • urinary retention
  • significant rectal pain
  • difficult or painful defaecation
  • incorrect positioning of the spacer
  • injection into the prostate
  • injury to the urethra or bladder
  • rectal-wall injury
  • rectal ulceration or tissue necrosis
  • vascular injection or embolisation
  • very rarely, fistula formation or severe pelvic infection.

This is why spacer insertion should be performed by clinicians experienced in transperineal ultrasound-guided procedures.

Correct placement matters just as much as the choice of spacer.


What happens to Barrigel afterwards?

Barrigel is biodegradable.

It remains between the prostate and rectum during the period when radiation treatment is being delivered and is subsequently broken down and absorbed by the body.

No second operation is normally required to remove it.


Barrigel versus SpaceOAR®

Barrigel and SpaceOAR are designed to solve the same anatomical problem, but they use different materials.

Barrigel SpaceOAR
Material Stabilised hyaluronic acid Polyethylene glycol hydrogel
Main purpose Separate prostate and rectum Separate prostate and rectum
Placement Transperineal injection Transperineal injection
Imaging guidance Ultrasound Ultrasound
Biodegradable Yes Yes
Remains permanently No No
Material characteristics Hyaluronic-acid gel that can be progressively shaped during injection PEG hydrogel formed after injection
Radiopaque version No equivalent to SpaceOAR Vue SpaceOAR Vue contains iodine for CT visibility
Evidence Randomised evidence demonstrating improved rectal dosimetry and reduced acute GI toxicity Extensive clinical experience and randomised/prospective evidence supporting rectal dose reduction

Both therefore create a temporary physical separation between the prostate and rectum.


Is Barrigel better than SpaceOAR?

At present it would be too simplistic to say that one spacer is universally “better”.

Both can substantially reduce radiation exposure to the rectum when correctly placed.

There are, however, some practical differences.

Barrigel can be shaped during insertion

Barrigel is injected as hyaluronic-acid gel. The operator can progressively deposit and shape the material while watching the developing space with ultrasound.

This can be useful when trying to achieve an appropriate distribution behind the prostate.

SpaceOAR has a long clinical track record

SpaceOAR has been extensively studied and is widely used internationally.

SpaceOAR Vue also contains iodine, making the spacer readily visible on CT. This may be helpful when MRI is unsuitable or when CT-based radiation planning is required.

Placement may matter more than the label on the syringe

An important point is that the quality, volume and position of the spacer can significantly influence the radiation dose received by the rectum.

A 2025 real-world comparative study found differences in dosimetry between Barrigel and SpaceOAR that were strongly influenced by the amount of spacer inserted. At comparable volumes, Barrigel performed favourably for some dosimetric measurements.

Interestingly, rectal-wall infiltration occurred in 7 of 287 SpaceOAR procedures (2.44%) and none of the Barrigel procedures in that particular study.

This does not prove that Barrigel is universally safer, but it highlights the importance of spacer material, injection technique and careful positioning.


What if Barrigel is not perfectly positioned?

One potentially useful characteristic of hyaluronic acid is that it can potentially be treated with hyaluronidase, an enzyme that breaks down hyaluronic acid.

This provides a theoretical and practical advantage if significant malposition is recognised.

The Queensland Clinical Excellence guidance specifically notes Barrigel’s potential to be hydrolysed in situations of spacer misplacement.

This does not make incorrect placement harmless, however. Prevention through meticulous ultrasound-guided insertion remains far preferable to correction afterwards.


Do all men having prostate radiation need a spacer?

No.

Modern radiation techniques such as IMRT, VMAT and image-guided radiotherapy already provide highly sophisticated targeting.

Whether a spacer provides meaningful additional benefit depends upon:

  • prostate anatomy and size
  • distance between prostate and rectum
  • radiation technique
  • radiation dose and fractionation
  • previous prostate or pelvic treatment
  • bowel disease
  • anticoagulation
  • individual risk of radiation toxicity
  • and the experience of the treating radiation team.

Some patients may gain considerable benefit while others may gain relatively little.

The decision should therefore be made jointly between the patient, radiation oncologist and urologist.


What does the evidence tell us?

The European Association of Urology recognises biodegradable rectal spacers as a method of increasing the distance between the prostate and rectum and reducing rectal radiation exposure.

Evidence across rectal spacer studies suggests reductions in both acute and late grade 2 or greater rectal toxicity.

For Barrigel specifically, a multicentre randomised trial demonstrated impressive dosimetric results during hypofractionated radiotherapy.

98.5% of patients receiving the hyaluronic-acid spacer achieved at least a 25% reduction in the volume of rectum receiving 54 Gy.

The average reduction was approximately 85%.

The same study demonstrated substantially fewer acute grade 2 or greater gastrointestinal side effects in patients receiving the spacer.

These findings support rectal spacing as a useful tool for appropriately selected men receiving prostate radiation therapy.


The bottom line

Barrigel is a temporary hyaluronic-acid rectal spacer used to create additional distance between the prostate and rectum before prostate cancer radiation therapy.

It does not improve the radiation by attacking the cancer. Instead, it gives the radiation oncologist a little more anatomical breathing room.

For appropriately selected patients it can:

increase prostate-to-rectum separation → reduce rectal radiation dose → reduce the risk of bowel toxicity.

Barrigel and SpaceOAR both achieve this objective using different biomaterials. Neither should automatically be regarded as the best option for every patient.

The choice should take into account the planned radiation technique, individual anatomy, previous treatment, medical history and the experience of the treating team.

Most importantly, a rectal spacer is an additional protective tool, not a guarantee against radiation-related bowel complications.

When should I discuss a rectal spacer?

If you are considering external-beam radiation therapy or SBRT for prostate cancer, it is reasonable to ask your radiation oncologist or urologist:

“Would I benefit from a rectal spacer, and would Barrigel or SpaceOAR be more appropriate for me?”

That conversation should occur before radiation planning begins.

This information is intended for patient education and does not replace individual assessment by your urologist or radiation oncologist.

So, if you have discussed this with your radiation oncologist and you would like the benefit of protecting your rectum against the effects of radiation, come see your local Brisbane urologist, Dr Jo, to discuss this option.

Information Sheet: Prostatitis