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Balloon catheter could offer Drug-Free relief for enlarged prostate

NCT ID NCT05567666

Disease control Sponsor: Dean Elterman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study is testing a device called the Optilume Catheter System, a drug-coated balloon that is inflated in the prostate to widen the urinary passage. It is designed for men with symptomatic benign prostatic hyperplasia (BPH), an enlarged prostate that causes bothersome urinary symptoms. The trial will measure how many men experience at least a 30% improvement in symptom scores after 12 months, without needing another procedure, and will track any side effects. The goal is to see if this minimally invasive approach can effectively relieve symptoms and improve quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Optilume Catheter System, a drug-coated balloon catheter
What this could lead to
If successful, this could offer men with enlarged prostate a minimally invasive option to relieve urinary symptoms without surgery.
What could go wrong
This is a small, real-world study without a comparison group, so results may not be definitive. Risks include potential side effects from the procedure, such as pain or urinary issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec 2. Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS 3. Able to complete the study protocol in the opinion of the investigator Exclusion Criteria: 1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements 2. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure 3. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate 4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate 5. Confirmed or suspected malignancy of prostate or bladder 6. Active urinary tract infection (UTI) confirmed by culture 7. History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable 8. Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.) 9. History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage) 10. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System 11. Significant obstruction from median lobe in the opinion of the investigator 12. Disease or other health condition that is not suitable for this study

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia

Contacts and locations

Locations

  • University Health Network

    Toronto, Ontario, M5T 2S8, Canada

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