About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs)
- Analysis of uroflowmetry data by EmanoFlow Mobile Application (App) and Emano Clinic Portal
Treatment groups
Sponsors and collaborators
University Hospital, Basel, Switzerland
Lead sponsor
Boston Scientific Corporation
Collaborator