Status:
RECRUITING
SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Benign Prostate Obstruction (BPO)
Eligibility:
MALE
18+ years
Brief Summary
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, durabilit...
Detailed Description
Prostate water vapor therapy (Rezum) is an approved treatment procedure for the management of lower urinary tract symptoms in men caused by benign prostatic obstruction (BPO). Rezum is performed trans...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05495633
Start Date
December 16 2022
End Date
December 1 2031
Last Update
December 4 2025
Active Locations (19)
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1
Universitätsklinikum Graz
Graz, Austria
2
Alexianer St. Hedwig-Krankenhaus
Berlin, Germany, 10115
3
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
4
Universitätsklinikum Hamburg-Eppendorf (UKE),
Hamburg, Germany, 20246