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
N/A
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
Researchers are evaluating Rezum water vapor therapy as a treatment for men with benign prostate obstruction (BPO) and lower urinary tract symptoms (LUTS). This large, prospective study involves 1000 patients and aims to assess the therapy's effectiveness, durability, and safety over a follow-up period of five years. The study also seeks to gather real-life data on outcomes and patient experiences with this minimally invasive procedure. Rezum therapy involves injecting steam at 1036C transurethrally into the enlarged prostate tissue using a disposable device with a retractable needle. Each injection takes 9 seconds, with about one injection per 10 ml of prostate tissue. The steam causes the prostate tissue to shrink gradually over three months, helping relieve obstruction. The procedure is short, can be done under local anesthesia, and aims to preserve sexual function. Patients are enrolled in a multicenter German-language web-based database to track clinical and patient-reported outcomes. Participants will complete various validated questionnaires and clinical tests such as uroflowmetry, quality of life assessments, sexual health measures, pain scales, and prostate imaging. Outcomes will be recorded at baseline, early post-treatment, and then regularly up to five years after therapy. Data on side effects, medication use, retreatment rates, and surgical safety are also collected. The study employs a home uroflowmetry app for some patients to monitor urine flow conveniently from home, supporting long-term evaluation and patient satisfaction.
CONDITIONS
Brief 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 lower urinary tract symptoms at participating centers
- Rezum treatment decision made independently by practitioner and patient
- 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 size over 80 ml
You will not qualify if you...
- Missing informed consent
- Unable to complete questionnaires due to language barriers or mental incapacity
- No personal email address and unwilling to complete surveys at the clinic
- Known or suspected neurogenic bladder dysfunction (e.g., Parkinson's disease, multiple sclerosis)
- History of malignant bladder tumor within last two years or present bladder cancer
- Previous prostate surgery within 4 weeks before Rezum treatment (except biopsy)
- Previous surgery on bladder neck
- Bladder neck stenosis requiring treatment at time of Rezum
- Planned combined Rezum with other urologic or non-urologic procedures, including transurethral procedures except bladder stone removal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Single day procedure with recovery over several weeks
Participants undergo Rezum water vapor therapy, a minimally invasive procedure involving steam injections into the prostate to relieve urinary symptoms caused by benign prostatic obstruction.
1 treatment visit (in-person)
Duration - Up to 5 years after treatment
Participants are followed to monitor recovery, treatment efficacy, side effects, and patient-reported outcomes through questionnaires and clinical assessments over several years.
Visits at 1 day, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and then annually up to 5 years
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
H
Heike Püschel, study nurse
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here