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Researchers are evaluating Rezum, a water vapor therapy, for the treatment of benign prostate obstruction (BPO) and lower urinary tract symptoms (LUTS) in men. This prospective, multi-center study includes 1000 patients and aims to assess the therapy's effectiveness, durability, and safety over a follow-up period of five years. The study collects data from real-life patients to better understand the role of Rezum in managing BPO and male LUTS, including impacts on sexual function and quality of life. Rezum therapy involves injecting 103°C steam into the enlarged prostate through a transurethral approach using a disposable handpiece. The steam causes prostate tissue to shrink by about 30% over three months due to thermal energy damage. The procedure is minimally invasive, typically taking only seconds per injection, and can be done under local anesthesia or analgesia. Patients receive treatment based on individual prostate size, with about one injection per 10 ml of tissue. Participants will be followed using a web-based German-language database to collect clinical and patient-reported outcomes via validated questionnaires and home urine flow measurements. If patients have compatible smartphones, they can use a mobile app to record urine flow at home. Researchers will measure changes in symptom scores and quality of life at multiple time points including baseline, 6 weeks, 3 months, 6 months, 12 months, and annually up to five years. Safety, functional outcomes, recovery, patient satisfaction, and the need for additional treatments will also be monitored throughout the study.

Age: 18Years +MALE
19 locations
Reinbek Clinical Trials | DecenTrialz