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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity Hospital, Basel, Switzerland

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

No treatment groups listed

Sponsors and collaborators

University Hospital, Basel, Switzerland

Lead sponsor

Boston Scientific Corporation

Collaborator