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Steam treatment for prostate troubles under the microscope in 1000-Man study

NCT ID NCT05495633

Symptom relief Sponsor: University Hospital, Basel, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 1000 men with an enlarged prostate who are receiving Rezum water vapor therapy, a minimally invasive steam treatment. The goal is to see how well it relieves urinary symptoms and improves quality of life over 5 years. Researchers will track symptom scores, urine flow, and safety in real-world patients.

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 1,000 people

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

Started

Dec 2022

Expected to finish

Dec 2031

An estimate. End dates often move.

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.

Who is studied

Patients who are treated with Rezum - water vapor therapy of the prostate due to benign prostate obstruction (BPO) or male lower urinary tract symptoms (LUTS) as part of routine clinical practice. Patients will be recruited within the participating study hospitals as part of regular patient care after an indication for Rezum treatment has been made independent of the study.

Ages

18 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: * All male patients who are treated with Rezum due to prostate obstruction and LUTS in the participating study centers can be included if certain inclusion criteria are met and some exclusion criteria are not present. * The indication to perform Rezum needs to be made independently from the study. The decision for Rezum treatment is the responsibility of each individual practitioner and patient. * Age ≥ 18 years * Operated or supervision of surgery by a certified urologist * Subgroups of special interest are e.g. catheter-dependent patients, patients with oral anticoagulation, patients with preoperative urodynamic pressure-flow investigation (not older than 6 months) or patients with prostates bigger than 80 ml Exclusion Criteria: * Missing informed consent * Lack of ability to answer questionnaires due to laguage problems or mental incapacity (e.g. in dementia, mental disability) * Patient does not have a personal email address available and the survey cannot be completed via a relative's email address and the patient is not willing to complete the survey on the tablet at the clinic * Known or suspected neurogenic bladder dysfunction in e.g. Parkinson's disease, multiple sclerosis or other neurological diseases with possible effects on bladder function * History of malignant bladder tumor in the last two years (including CIS) or currently present malignant bladder tumor at time of Rezum treatment (including CIS) * Previous operation(s) on the prostate, except prostate biopsy, if this was performed more than 4 weeks ago at time of Rezum treatment * Previous operation(s) on the bladder neck * Presence of bladder neck stenosis requiring treatment at time of Rezum treatment * Planned combination of Rezum treatment concurrently with another urologic (\*) or non-urologic procedure (\*) also the combination with a planned transurethral procedure is not allowed except for bladder stone removal

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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 prostate obstruction (BPO)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alexianer St. Hedwig-Krankenhaus

    RECRUITING

    Berlin, 10115, Germany

  • Asklepios Westklinikum Hamburg GmbH

    RECRUITING

    Hamburg, 22559, Germany

  • Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinen gGmbH

    NOT_YET_RECRUITING

    Stuttgart, 70176, Germany

  • Hirslanden Klinik St. Anna

    RECRUITING

    Lucerne, 6006, Switzerland

  • Inselspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Kantonsspital Aarau

    RECRUITING

    Aarau, 5001, Switzerland

  • Kantonsspital Luzern

    RECRUITING

    Lucerne, Switzerland

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, Switzerland

  • Kliniken Sindelfingen

    RECRUITING

    Sindelfingen, 71065, Germany

  • Klinikum Nürnberg

    RECRUITING

    Nuremberg, 90419, Germany

  • Krankenhaus Maria Hilf - Alexianer Krefeld

    RECRUITING

    Krefeld, 47805, Germany

  • Krankenhaus Reinbek St. Adolf Stift

    RECRUITING

    Reinbek, 21465, Germany

  • University Hospital Basel, Department of Urology

    RECRUITING

    Basel, 4031, Switzerland

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • Universitätsklinikum Graz

    ACTIVE_NOT_RECRUITING

    Graz, Austria

  • Universitätsklinikum Hamburg-Eppendorf (UKE),

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Universitätsspital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

  • Urologische Gemeinschaftspraxis Prüner Gang

    RECRUITING

    Kiel, 24103, Germany

  • Uroviva AG

    RECRUITING

    Rothrist, 4852, Switzerland

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