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RECRUITING
NCT05495633

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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