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

NCT ID: NCT05495633

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2031-12-31

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.

Detailed Description

Prostate water vapor therapy (Rezum) is an approved treatment procedure for the management of lower urinary tract symptoms in men caused by benign prostatic obstruction (BPO). Rezum is performed transurethrally by steam injections into the central or transition zone of the enlarged prostate. The 103°C hot steam is generated by a generator and injected into the prostate tissue via a disposable handpiece with a retractable needle. Approximately 1 injection is required per 10 ml of prostate tissue to achieve desobstruction. The single injection takes only 9 seconds. The thermal energy contained in the water vapor is able to develop evenly and freely in the intercellular space of the prostate by convection. This represents a unique technique in surgical desobstruction of the prostate. The steam condenses and releases the stored heat energy to the cell membranes, which then denature. As a result, the prostate tissue shrinks by about 30% in the first three months after the Rezum treatment. The shrinkage process therefore does not take place immediately, but with a time delay. The minimally invasive nature of the procedure results from the short surgical time, the potential of Rezum to preserve sexual function (both ejaculation and erection), and the possibility of performing Rezum even under local anesthesia or analgesia. Data on efficacy, durability of efficacy, safety/complications, and indication groups are still limited. "Real life" data are important to determine the role of Rezum water vapor therapy in the treatment of BPO and male LUTS. The aim of this study is to prospectively enroll and follow Rezum patients in a multicenter, German-language, web-based database. Patient-reported outcome measures (PROMs) and clinical-reported outcome measures/data (CROMs) on various subgroups of patients treated with Rezum as a routine clinical treatment option for BPO-related male LUTS will be recorded in terms of procedure efficacy, functional outcomes (e.g. sexual function) and surgical safety. Further aspects of interest are recovery from the procedure, patients' expectations towards Rezum treatment, patients' satisfaction with Rezum treatment, and impact of Rezum on quality of life.

Conditions

Benign Prostate Obstruction (BPO)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Ebbing, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Urology

Locations

Universitätsklinikum Graz

Graz, , Austria

Site Status: ACTIVE_NOT_RECRUITING

Alexianer St. Hedwig-Krankenhaus

Berlin, , Germany

Site Status: RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Site Status: RECRUITING

Universitätsklinikum Hamburg-Eppendorf (UKE),

Hamburg, , Germany

Site Status: NOT_YET_RECRUITING

Asklepios Westklinikum Hamburg GmbH

Hamburg, , Germany

Site Status: RECRUITING

Urologische Gemeinschaftspraxis Prüner Gang

Kiel, , Germany

Site Status: RECRUITING

Krankenhaus Maria Hilf - Alexianer Krefeld

Krefeld, , Germany

Site Status: RECRUITING

Klinikum Nürnberg

Nuremberg, , Germany

Site Status: RECRUITING

Krankenhaus Reinbek St. Adolf Stift

Reinbek, , Germany

Site Status: RECRUITING

Kliniken Sindelfingen

Sindelfingen, , Germany

Site Status: RECRUITING

Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinen gGmbH

Stuttgart, , Germany

Site Status: NOT_YET_RECRUITING

Kantonsspital Aarau

Aarau, Aarau, Switzerland

Site Status: RECRUITING

Hirslanden Klinik St. Anna

Lucerne, Canton of Lucerne, Switzerland

Site Status: RECRUITING

University Hospital Basel, Department of Urology

Basel, , Switzerland

Site Status: RECRUITING

Inselspital Bern

Bern, , Switzerland

Site Status: RECRUITING

Kantonsspital Luzern

Lucerne, , Switzerland

Site Status: RECRUITING

Uroviva AG

Rothrist, , Switzerland

Site Status: RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Austria; Germany; Switzerland

Central Contacts

Martina Becker, study nurse

Role: CONTACT

SteamOne.urologie@usb.ch

+41 61 328 56 59

Heike Püschel, study nurse

Role: CONTACT

SteamOne.urologie@usb.ch

+41 61 556 54 77

Facility Contacts

Tobias Bothmann, Dr

Role: primary

Miriam Traumann, Dr

Role: primary

Philipp Gild, Dr. med

Role: primary

Dunja Diarra

Role: backup

+49 40 7410 54836

Guiseppe Magistro, PD Dr, med

Role: primary

Christof van der Horst, MD

Role: primary

+49 431 2604290

Kamran Karim, MD

Role: primary

k.karim@alexianer.de

+49 2151 334 1806

Sascha Pahernik, Prof. MD

Role: primary

urologie@klinikum-nuernberg.de

Friederike Walther

Role: backup

+49 (0) 911-398112681

Claus Brunken, Dr

Role: primary

Johannes Dlugosch

Role: primary

Renate Endriss

Role: backup

+49 7031-98 18968

Daniel Seidl, Dr

Role: primary

Sabine Nuding

Role: backup

+49 711 991-3517

Lukas Prause, Dr.med.univ.

Role: primary

lukas.prause@ksa.ch

+41 62 838 47 59

Felix Moltzahn, Dr. med.

Role: primary

felix.moltzahn@hin.ch

+41 41 410 4170

Jan Ebbing, PD Dr. med.

Role: primary

SteamOne.urologie@usb.ch

+41 61 328 56 59

Karl-Georg Sommer, Dr. med

Role: primary

Anselm Lafita

Role: backup

+41 31 632 23 32

Nico Grossmann, MD

Role: primary

nico.grossmann@luks.ch

+41 41 205 66 83

Andrej Panic, Dr

Role: primary

+41 41 934 00 73

Olivia Köhle, MD

Role: primary

+41 71 494 14 16

Etienne Xavier Keller, Dr. med

Role: primary

Alexandra Uster

Role: backup

+41 44 255 54 26

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.unispital-basel.ch/urologie/forschung-urologie/steamone

SteamOne Homepage (German Language)

Other Identifiers

2022-00544; bb21Ebbing

Identifier Type: -

Identifier Source: org_study_id