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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

NCT07507591 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Benign Prostate Hyperplasia

Interventions

DEVICE

Rezum Water Vapor Thermal Therapy

Transurethral convective water vapor thermal therapy used for the treatment of benign prostatic hyperplasia.

Sponsors & Collaborators

  • ALI KAMAL M. SAMI

    lead OTHER

Principal Investigators

  • Ali K M.Sami, M.B.Ch.B., F.I.B.M.S.( PhD) · College of Medicine, University of Sulaimani

Eligibility

Min Age
45 Years
Max Age
96 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2026-03-12
Completion
2026-03-12

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507591 on ClinicalTrials.gov