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Battle of the BPH procedures: which one gets you off the catheter faster?

NCT ID NCT04338776

Symptom relief Sponsor: NeoTract, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares two minimally invasive procedures for treating an enlarged prostate (BPH) in 120 men aged 50 and older. The goal is to see which treatment—UroLift or Rezūm—leads to fewer catheters, less need for repeat procedures, and lower medication use over 12 months. The main focus is on how quickly patients can urinate without a catheter after treatment.

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

About 120 people

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

Started

Jan 2021

Expected to finish

Dec 2025

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.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 gender 2. Age ≥ 50 years 3. Diagnosis of symptomatic BPH 4. Prostate volume 30cm3 ≤ 80cm3 5. Willing to sign study informed consent form Exclusion Criteria: 1. Current urinary tract infection 2. Current catheter dependent urinary retention or PVR \>= 500 mL 3. Urethra conditions that may prevent insertion of delivery system into bladder 4. Previous BPH surgical procedure 5. Urinary incontinence presumed due to incompetent sphincter 6. Current gross hematuria 7. Patients with a urinary sphincter implant 8. Patients who have a penile prosthesis 9. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint

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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

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Comprehensive Urology

    Royal Oak, Michigan, 48073, United States

  • Frimley Park Hospital

    Frimley, Camberley, 6U167UJ UK, United Kingdom

  • NORFOLK and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • NYU Winthrop Urology

    Garden City, New York, 11530, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75048, United States

  • Urology Austin

    Austin, Texas, 78759, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Weil Cornell Medical College, Cornell University

    New York, New York, 10065, United States

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