Clinical Trial

Safety, Efficacy, and Short-Term Outcomes of Rezūm Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia Under Local Anesthesia With Intravenous Sedation: A Single-Center Retrospective Study of 129 Patients in the Kurdistan Region of Iraq

Completed
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Summary
This single-center retrospective study evaluates the safety, feasibility, and short-term clinical outcomes of Rezūm water vapor thermal therapy (WVTT) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in patients treated under local anesthesia with intravenous sedation. The study was conducted at Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq, and includes 129 consecutive patients aged 45 to 96 years with prostate volumes ranging from 30 to 120 grams. Outcomes assessed include symptom improvement, urinary flow, post-void residual volume, quality of life, erectile function, prostate volume reduction, catheter-related outcomes, perioperative complications, and retreatment rates. This study aims to provide real-world evidence regarding the use of Rezūm therapy in a high-comorbidity population and in a Middle Eastern clinical setting.
Trial Details
NCT Number NCT07507591
Lead Sponsor ALI KAMAL M. SAMI
Conditions Benign Prostate Hyperplasia
Enrollment 129 participants
Start Date 2025-09-03
Primary Completion 2026-03-12 (estimated)
Study Completion 2026-03-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-02