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Steam vs. pills: new study tests better fix for enlarged prostate in sexually active men

NCT ID NCT04838769

Disease control Sponsor: Boston Scientific Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 6 times

Summary

This study compares a minimally invasive water vapor treatment (REZŪM) to taking two drugs together for men with an enlarged prostate that didn't get better with one drug. It includes 155 sexually active men aged 45 and older. The goal is to see which approach better improves urinary symptoms and sexual health.

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

155 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2026

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

45 years and older

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. Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy 2. Subject is willing and able to answer all domains of MSHQ 3. Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment 4. Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment 5. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment 6. Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment 7. Subject is willing and capable of providing informed consent 8. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP) 9. France subjects only: subjects must be affiliated to national security insurance Exclusion Criteria: 1. Inability to participate in full duration of study 2. Prior surgical treatment for BPH 3. Increased risk of bleeding 4. Presence of Genitourinary Cancer or other pelvic cancer 5. Functional issues with bladder 6. Presence of active infection in genitourinary tract 7. Structural and Anatomic issues with urinary tract and renal function 8. Concomitant Drug Therapy 9. Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

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

Benign prostatic hyperplasia (BPH)

Contacts and locations

Locations

  • Australian Clinical Trials

    Wahroonga, Australia

  • CHU Grenoble

    Grenoble, France

  • CHU d'Angers

    Angers, France

  • CHU de Bordeaux

    Bordeaux, France

  • CHU de Nice

    Nice, France

  • CHU de Rennes

    Rennes, France

  • CHU de Rouen

    Rouen, France

  • CHU de Toulouse

    Toulouse, France

  • Centre Hospitalier Privé Saint Grégoire

    Saint-Grégoire, France

  • Centre Hospitalier Universitaire de Lille

    Lille, France

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, France

  • Clinique La Croix du Sud

    Quint-Fonsegrives, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique Saint Hilaire

    Rouen, France

  • Epworth Healthcare

    Melbourne, Australia

  • Hospices Civils de Lyon

    Lyon, France

  • Hôpital Bichat

    Paris, France

  • Hôpital Cochin

    Paris, France

  • Hôpital Privé La Louvière

    Lille, France

  • Hôpital privé Francheville

    Périgueux, France

  • Institut Mutualiste Montsouris

    Paris, France

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