RecruitingNCT05495633

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

Sponsor

University Hospital, Basel, Switzerland

Enrollment

1,000 participants

Start Date

Dec 16, 2022

Study Type

OBSERVATIONAL

Conditions

Benign Prostate Obstruction (BPO)

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks real-world outcomes for men treated with the Rezum procedure, a minimally invasive steam therapy that reduces prostate tissue to relieve urinary symptoms caused by an enlarged prostate. You may be eligible if: - You are a male aged 18 or older - You are being treated with Rezum for prostate obstruction and urinary symptoms - You are willing to complete questionnaires (online or at the clinic) You may NOT be eligible if: - You are unable or unwilling to give informed consent - You have difficulty completing questionnaires due to language barriers or cognitive impairment (such as dementia) - You have no personal or relative's email address and are unwilling to complete the survey on a clinic tablet - You have a known neurological condition affecting bladder function (e.g., Parkinson's, multiple sclerosis) - You have had a malignant bladder tumor in the last two years - You have had previous prostate surgery (other than a biopsy performed more than 4 weeks ago) - You have had previous bladder neck surgery or currently have bladder neck stenosis requiring treatment - You are having Rezum combined with another urological or non-urological procedure at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCollection 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.

OTHERAnalysis 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, Switzerland

University Hospital Basel, Department of Urology

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

Hirslanden Klinik St. Anna

Lucerne, Switzerland

Kantonsspital Luzern

Lucerne, Switzerland

Uroviva AG

Rothrist, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

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