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

NCT05495633 | Recruiting

• 1 other identifier: 2022-00544; bb21Ebbing
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 19

Brief 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)

Keywords

Lower Urinary Tract Symptoms (LUTS); Rezum water vapor therapy; prostate

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL)

  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).

  At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum

Secondary Outcomes (27)

• Change of maximum urinary flow rate (Qmax) measured by uroflowmetry

  At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum

• Change of International Consultation on Incontinence Questionnaire for male lower urinary tract symptoms (ICIQ-MLUTS)

  At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum

• Change of Male Sexual Health Questionnaire (MSHQ)

  At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum

• Change of International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-MLUTSsex)

  At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum

• Patient's postoperative recovery by QoR-15

  At baseline, at the first postoperative day and 2 weeks after treatment with Rezum

Interventions

Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs) OTHER

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 OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are treated with Rezum - water vapor therapy of the prostate due to benign prostate obstruction (BPO) or male lower urinary tract symptoms (LUTS) as part of routine clinical practice. Patients will be recruited within the participating study hospitals as part of regular patient care after an indication for Rezum treatment has been made independent of the study.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Boston Scientific Corporation: collaborator

Study Sites (19)

Universitätsklinikum Graz

Graz, Austria

ACTIVE NOT RECRUITING

Alexianer St. Hedwig-Krankenhaus

Berlin, 10115, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf (UKE),

Hamburg, 20246, Germany

NOT YET RECRUITING

Asklepios Westklinikum Hamburg GmbH

Hamburg, 22559, Germany

RECRUITING

Urologische Gemeinschaftspraxis Prüner Gang

Kiel, 24103, Germany

RECRUITING

Krankenhaus Maria Hilf - Alexianer Krefeld

Krefeld, 47805, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, 90419, Germany

RECRUITING

Krankenhaus Reinbek St. Adolf Stift

Reinbek, 21465, Germany

RECRUITING

Kliniken Sindelfingen

Sindelfingen, 71065, Germany

RECRUITING

Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinen gGmbH

Stuttgart, 70176, Germany

NOT YET RECRUITING

Kantonsspital Aarau

Aarau, Aarau, 5001, Switzerland

RECRUITING

Hirslanden Klinik St. Anna

Lucerne, Canton of Lucerne, 6006, Switzerland

RECRUITING

University Hospital Basel, Department of Urology

Basel, 4031, Switzerland

RECRUITING

Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Kantonsspital Luzern

Lucerne, Switzerland

RECRUITING

Uroviva AG

Rothrist, 4852, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

Related Links

• SteamOne Homepage (German Language)

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Patient Reported Outcome Measures; Amyloid

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jan Ebbing, PD Dr. med.

  University Hospital Basel, Department of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Becker, study nurse

CONTACT

+41 61 328 56 59; SteamOne.urologie@usb.ch

Heike Püschel, study nurse

CONTACT

+41 61 556 54 77; SteamOne.urologie@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 10, 2022
• Study Start: December 16, 2022
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

CH (8); AU (1); DE (10)