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

NCT05495633 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-07

No results posted yet for this 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.

Conditions

  • Benign Prostate Obstruction (BPO)

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).

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Jan Ebbing, PD Dr. med. · University Hospital Basel, Department of Urology

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495633 on ClinicalTrials.gov