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

NCT05495633 · tracked via the Priya Life Science Switzerland tracker

Sponsor

University Hospital, Basel, Switzerland

Phase

Observational

Started

2022-12-16

Last updated

2026-05-07

Condition(s) studied

Benign Prostate Obstruction (BPO)

Investigational drug(s) / intervention(s)

Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs)Analysis of uroflowmetry data by EmanoFlow Mobile Application (App) and Emano Clinic Portal

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).

Study 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

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 exclusion criteria are not present. * 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 Exclusion Criteria: * Missing informed consent * Lack of ability to answer questionnaires due to laguage problems or mental incapacity (e.g. in dementia, mental disability) * Patient does not have a personal email address available and the survey cannot be completed via a relative's email address and the patient is not willing to complete the survey on the tablet at the clinic * Known or suspected neurogenic bladder dysfunction in e.g. Parkinson's disease, multiple sclerosis or other neurological diseases with possible effects on bladder function * History of malignant bladder tumor in the last two years (including CIS) or currently present malignant bladder tumor at time of Rezum treatment (including CIS) * Previous operation(s) on the prostate, except prostate biopsy, if this was performed more than 4 weeks ago at time of Rezum treatment * Previous operation(s) on the bladder neck * Presence of bladder neck stenosis requiring treatment at time of Rezum treatment * Planned combination of Rezum treatment concurrently with another urologic (\*) or non-urologic procedure (\*) also the combination with a planned transurethral procedure is not allowed except for bladder stone removal

Primary outcome measure(s)

Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL) — At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
The IPSS is an eight-item validated questionnaire, consisting of seven symptom questions and one QoL question. The IPSS score is categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points).

Trial sites (19)

Facility	City	Region	Status
Universitätsklinikum Graz	Graz	Austria	Active Not Recruiting
Alexianer St. Hedwig-Krankenhaus	Berlin	Germany	Recruiting
Universitätsklinikum Frankfurt	Frankfurt	Germany	Recruiting
Universitätsklinikum Hamburg-Eppendorf (UKE),	Hamburg	Germany	Not Yet Recruiting
Asklepios Westklinikum Hamburg GmbH	Hamburg	Germany	Recruiting
Urologische Gemeinschaftspraxis Prüner Gang	Kiel	Germany	Recruiting
Krankenhaus Maria Hilf - Alexianer Krefeld	Krefeld	Germany	Recruiting
Klinikum Nürnberg	Nuremberg	Germany	Recruiting
Krankenhaus Reinbek St. Adolf Stift	Reinbek	Germany	Recruiting
Kliniken Sindelfingen	Sindelfingen	Germany	Recruiting
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinen gGmbH	Stuttgart	Germany	Not Yet Recruiting
Kantonsspital Aarau	Aarau	Switzerland	Recruiting
University Hospital Basel, Department of Urology	Basel	Switzerland	Recruiting
Inselspital Bern	Bern	Switzerland	Recruiting
Hirslanden Klinik St. Anna	Lucerne	Switzerland	Recruiting
Kantonsspital Luzern	Lucerne	Switzerland	Recruiting
Uroviva AG	Rothrist	Switzerland	Recruiting
Kantonsspital St. Gallen	Sankt Gallen	Switzerland	Recruiting
Universitätsspital Zürich	Zurich	Switzerland	Recruiting

More University Hospital, Basel, Switzerland trials in Switzerland

Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion) Active, not recruiting

Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System Starting soon

Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators. Recruiting

Swiss National Registry of Adults With Congenital Heart Disease Recruiting

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05495633 on ClinicalTrials.gov ↗ ← All trials in Switzerland