Safety, Efficacy, and Short-Term Outcomes of Rezūm Water Vapor Thermal Therapy for Benign Prostat… (NCT07507591) | Clinical Trial Compass
CompletedNot Applicable
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
Iraq129 participantsStarted 2025-09-03
Plain-language 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.
Who can participate
Age range45 Years – 96 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Maximum urinary flow rate (Qmax) less than 15 mL/s on uroflowmetry.
✓. Prostate volume 30 to 120 g on transrectal or transabdominal ultrasonography.
✓. Failure of medical therapy or intolerance to medical therapy.
✓. Catheter-dependent urinary retention secondary to benign prostatic hyperplasia in patients who were not candidates for or declined conventional surgical intervention.
✓. Consecutive patients who underwent Rezūm water vapor thermal therapy during the study period.
Exclusion criteria
✕. Pre-existing erectile dysfunction not attributable to benign prostatic hyperplasia medication side effects.
✕. Retrograde ejaculation not caused by alpha-blocker therapy.
What they're measuring
1
Change in International Prostate Symptom Score (IPSS)
Timeframe: Baseline, 1 month, and 3 months
2
Change in Maximum Urinary Flow Rate (Qmax)
Timeframe: Baseline, 1 month, and 3 months
3
Change in Post-Void Residual Volume (PVR)
Timeframe: Baseline, 1 month, and 3 months
4
Change in Quality of Life (QoL) Score
Timeframe: Baseline, 1 month, and 3 months
5
Change in International Index of Erectile Function (IIEF)
✕. Lower urinary tract symptoms attributable to causes other than benign prostatic hyperplasia, including neurogenic bladder or bladder overactivity unrelated to benign prostatic hyperplasia.
✕. History of previous bladder surgery, prostate surgery, or urethral stricture surgery.