Database for Rezum Water Vapor Therapy for Prostate Issues

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

This study is testing how well Rezum water vapor therapy works for men with prostate issues and urinary symptoms by collecting data from 1000 patients over five years.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 19 sites (Graz and 18 other locations)
• Trial ID: NCT05495633 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect and analyze clinical data on the efficacy, durability, and safety of Rezum water vapor therapy in treating benign prostate obstruction (BPO) and lower urinary tract symptoms (LUTS) in men. The study will involve a large cohort of 1000 patients across multiple centers, with a follow-up period of five years. Rezum therapy involves the injection of steam into the prostate to reduce tissue size and alleviate symptoms. The study will evaluate patient-reported outcomes and uroflowmetry data to assess treatment effectiveness in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates include male patients aged 18 and older who are undergoing Rezum treatment for prostate obstruction and LUTS.

Not a fit: Patients who are unable to provide informed consent or have significant cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of Rezum therapy, potentially improving treatment options for men with BPO.

How similar studies have performed: While Rezum therapy has been approved, this study aims to gather extensive real-life data, making it a novel approach to understanding its long-term outcomes.

Eligibility criteria

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

Where this trial is running

Graz and 18 other locations

• 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)

Study contacts

• Principal investigator: Jan Ebbing, PD Dr. med. — University Hospital Basel, Department of Urology
• Study coordinator: Niklas Simon, Study Coordinator

Conditions Benign Prostate Obstruction; Lower Urinary Tract Symptoms; Rezum water vapor therapy; prostate