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 range
45 Years – 96 Years
Sex
MALE
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. Pre-existing erectile dysfunction not attributable to benign prostatic hyperplasia medication side effects.
. Retrograde ejaculation not caused by alpha-blocker therapy.
. 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.