Prospective Study of Rezum Water Vapor Therapy for Benign Prostate Obstruction and Male Urinary Symptoms with 5-Year Follow-Up

What this Trial Is About

Researchers are evaluating Rezum water vapor therapy as a treatment for men with benign prostate obstruction BPO and lower urinary tract symptoms LUTS. This large, prospective study involves 1000 patients and aims to assess the therapys effectiveness, durability, and safety over a follow-up period of five years. The study also seeks to gather real-life data on outcomes and patient experiences with this minimally invasive procedure. Rezum therapy involves injecting steam at 1036C transurethrally into the enlarged prostate tissue using a disposable device with a retractable needle. Each injection takes 9 seconds, with about one injection per 10 ml of prostate tissue. The steam causes the prostate tissue to shrink gradually over three months, helping relieve obstruction. The procedure is short, can be done under local anesthesia, and aims to preserve sexual function. Patients are enrolled in a multicenter German-language web-based database to track clinical and patient-reported outcomes. Participants will complete various validated questionnaires and clinical tests such as uroflowmetry, quality of life assessments, sexual health measures, pain scales, and prostate imaging. Outcomes will be recorded at baseline, early post-treatment, and then regularly up to five years after therapy. Data on side effects, medication use, retreatment rates, and surgical safety are also collected. The study employs a home uroflowmetry app for some patients to monitor urine flow conveniently from home, supporting long-term evaluation and patient satisfaction.

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