Clinical Research Directory
Browse clinical research sites, groups, and studies.
SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
Sponsor: University Hospital, Basel, Switzerland
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, durability and safety in a large, prospective, multi-center cohort consisting of 1000 "real-life" patients with a follow-up of 5 years.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2022-12-16
Completion Date
2031-12
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs)
The study uses a web-based German-language database (electronic data capture system, EDCS) called "REDCap" that provides both clinical reported outcome measures (CROMs) and patient-reported outcome measures (PROMs). PROMs are investigated by validated questionnaires: IPSS/QoL, ICIQ-MLUTS, MSHQ, ICIQ-MLUTSsex, QoR-15GE, PROMIS Global Health 10, ICIQ-S, NRS, and by home urine flow measurement (initially iUFlow, since October 2025 EmanoFlow ) as well as by self-designed questionnaires to assess patients´ preferences and expectations for Rezum and for surgical therapy of the prostate, satisfaction with the Rezum therapy, side effects of the Rezum therapy, (re)medication to treat BPO and LUTS, and reoperations after Rezum therapy.
Analysis of uroflowmetry data by EmanoFlow Mobile Application (App) and Emano Clinic Portal
If patients have a smartphone with app function (Android or Apple), they will be provided with an FDA-registered home uroflowmetry mobile App (called EmanoFlow from Emano Metrics, USA) at study entry. This AI-based mobile application should enable patients to measure their urine flow conveniently from home and thus be independent of the medical consultation. EmanoFlow is marketed by Emano Metrics Inc., a Delaware C Corporation with its principal place of business at 132 East Broadway Suite 700, Eugene, OR, 97401, USA. Every time a patient is using the mobile App urine flow measurement data will be sent to the home uroflowmetry database (Emano Flow Clinic Portal).
Locations (19)
Universitätsklinikum Graz
Graz, Austria
Alexianer St. Hedwig-Krankenhaus
Berlin, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE),
Hamburg, Germany
Asklepios Westklinikum Hamburg GmbH
Hamburg, Germany
Urologische Gemeinschaftspraxis Prüner Gang
Kiel, Germany
Krankenhaus Maria Hilf - Alexianer Krefeld
Krefeld, Germany
Klinikum Nürnberg
Nuremberg, Germany
Krankenhaus Reinbek St. Adolf Stift
Reinbek, Germany
Kliniken Sindelfingen
Sindelfingen, Germany
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinen gGmbH
Stuttgart, Germany
Kantonsspital Aarau
Aarau, Aarau, Switzerland
Hirslanden Klinik St. Anna
Lucerne, Canton of Lucerne, Switzerland
University Hospital Basel, Department of Urology
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Uroviva AG
Rothrist, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Universitätsspital Zürich
Zurich, Switzerland