Actively Recruiting

Age: 18Years +
MALE
NCT05495633

SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate

Led by University Hospital, Basel, Switzerland · Updated on 2026-05-07

1000

Participants Needed

19

Research Sites

467 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Basel, Switzerland

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is to assess the clinical data of Rezum (water vapor therapy) in patients with BPO (benign prostate obstruction) and male LUTS (lower urinary tract symptoms) in terms of efficacy, durability and safety in a large, prospective, multi-center cohort consisting of 1000 "real-life" patients with a follow-up of 5 years.

CONDITIONS

Official Title

SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients treated with Rezum for prostate obstruction and LUTS at participating centers
  • Decision to perform Rezum made independently from the study
  • Age 18 years or older
  • Surgery performed or supervised by a certified urologist
  • Includes special groups such as catheter-dependent patients, those on oral anticoagulation, patients with recent urodynamic testing, or prostate volume over 80 ml
Not Eligible

You will not qualify if you...

  • Missing informed consent
  • Inability to answer questionnaires due to language barriers or mental incapacity
  • No personal email and unwillingness to complete surveys on clinic tablet
  • Known or suspected neurogenic bladder dysfunction from neurological diseases
  • History or current malignant bladder tumor within last two years
  • Previous prostate surgery except biopsy older than 4 weeks
  • Previous bladder neck surgery
  • Presence of bladder neck stenosis needing treatment at time of Rezum
  • Planned combination of Rezum with other urologic or non-urologic procedures (except bladder stone removal)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Universitätsklinikum Graz

Graz, Austria

Active, Not Recruiting

2

Alexianer St. Hedwig-Krankenhaus

Berlin, Germany, 10115

Actively Recruiting

3

Universitätsklinikum Frankfurt

Frankfurt, Germany, 60590

Actively Recruiting

4

Universitätsklinikum Hamburg-Eppendorf (UKE),

Hamburg, Germany, 20246

Not Yet Recruiting

5

Asklepios Westklinikum Hamburg GmbH

Hamburg, Germany, 22559

Actively Recruiting

6

Urologische Gemeinschaftspraxis Prüner Gang

Kiel, Germany, 24103

Actively Recruiting

7

Krankenhaus Maria Hilf - Alexianer Krefeld

Krefeld, Germany, 47805

Actively Recruiting

8

Klinikum Nürnberg

Nuremberg, Germany, 90419

Actively Recruiting

9

Krankenhaus Reinbek St. Adolf Stift

Reinbek, Germany, 21465

Actively Recruiting

10

Kliniken Sindelfingen

Sindelfingen, Germany, 71065

Actively Recruiting

11

Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinen gGmbH

Stuttgart, Germany, 70176

Not Yet Recruiting

12

Kantonsspital Aarau

Aarau, Switzerland, 5001

Actively Recruiting

13

University Hospital Basel, Department of Urology

Basel, Switzerland, 4031

Actively Recruiting

14

Inselspital Bern

Bern, Switzerland, 3010

Actively Recruiting

15

Hirslanden Klinik St. Anna

Lucerne, Switzerland, 6006

Actively Recruiting

16

Kantonsspital Luzern

Lucerne, Switzerland

Actively Recruiting

17

Uroviva AG

Rothrist, Switzerland, 4852

Actively Recruiting

18

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Actively Recruiting

19

Universitätsspital Zürich

Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

N

Niklas Simon, Study Coordinator

CONTACT

H

Heike Püschel, study nurse

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate | DecenTrialz