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New catheter device offers hope for men with enlarged prostate

NCT ID NCT06560476

Symptom relief Sponsor: Urotronic Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tracks 500 men with symptomatic benign prostatic hyperplasia (BPH) who receive the Optilume BPH Catheter System in real-world clinics. The goal is to see how well the device eases urinary symptoms and how safe it is over 12 months. Participants must follow contraception rules and have no other implants or prostate cancer.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.

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\. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU). Exclusion Criteria: 1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure 2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate 3. Confirmed or suspected malignancy of prostate or bladder. 4. Active urinary tract infection (UTI) 5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

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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

  • Florida Urology Partners

    Tampa, Florida, 33615, United States

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330, United States

  • Kearney Urology Center

    Kearney, Nebraska, 68847, United States

  • Midtown Urology

    Austin, Texas, 78705, United States

  • Northwell Health - Smith Institute of Urology

    Syosset, New York, 11791, United States

  • Potomac Urology

    Woodridge, Virginia, 22191, United States

  • Sheldon Freedman, Ltd

    Las Vegas, Nevada, 89144, United States

  • The Urology Center, P.C.

    Omaha, Nebraska, 68144, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.