Actively Recruiting
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
Eligibility Criteria
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
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
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
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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