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 | Completed DMC

• 1 other identifier: 21022023
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Intravenous Sedation; Local Anesthesia; Prostate Enlargement; Urinary Retention; Minimally Invasive Therapy; Water Vapor Thermal Therapy; Rezum; LUTS; BPH

Outcome Measures

Primary Outcomes (6)

• Change in International Prostate Symptom Score (IPSS)

  Change in IPSS from baseline to follow-up after Rezūm water vapor thermal therapy.

  Baseline, 1 month, and 3 months

• Change in Maximum Urinary Flow Rate (Qmax)

  Change in maximum urinary flow rate from baseline to follow-up after treatment.

  Baseline, 1 month, and 3 months

• Change in Post-Void Residual Volume (PVR)

  Change in post-void residual urine volume from baseline to follow-up after treatment.

  Baseline, 1 month, and 3 months

• Change in Quality of Life (QoL) Score

  Change in disease-specific quality of life score from baseline to follow-up after treatment.

  Baseline, 1 month, and 3 months

• Change in International Index of Erectile Function (IIEF)

  Change in erectile function as assessed by IIEF from baseline to follow-up after treatment.

  Baseline, 1 month, and 3 months

• Change in Prostate Volume

  Change in prostate volume from baseline to follow-up after treatment.

  Baseline, 1 month, and 3 months

Secondary Outcomes (6)

• Perioperative and Postoperative Complications

  From procedure date to 3 months

• Catheterization Duration

  From procedure date until catheter removal, up to 12 days

• Hospital Discharge Time

  Day of procedure to next day

• Retreatment or Conversion to Alternative Surgery

  Up to 3 months

• Incidence of Retrograde Ejaculation

  From procedure date to 3 months

Study Arms (1)

Patients with BPH treated with Rezum

Consecutive patients with benign prostatic hyperplasia who underwent Rezūm water vapor thermal therapy at a single center under local anesthesia with intravenous sedation.

Device: Rezum Water Vapor Thermal Therapy

Interventions

Rezum Water Vapor Thermal Therapy DEVICE

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

Patients with BPH treated with Rezum

Eligibility Criteria

• Age: 45 Years - 96 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia who underwent Rezūm water vapor thermal therapy at Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq.

You may qualify if:

• Male patients aged 45 years or older.
• Moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia (IPSS ≥8).
• 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.

You may not qualify if:

• 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.
• Presence of vesical calculi.
• Confirmed neurogenic bladder.
• Suspected or confirmed prostate malignancy.

Sponsors & Collaborators

• ALI KAMAL M. SAMI: lead

Study Sites (1)

Royal Hospital

Sulaymaniyah, Kurdistan Region of Iraq (kri), 46001, Iraq

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Retention

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Ali K M.Sami, M.B.Ch.B., F.I.B.M.S.( PhD)

  College of Medicine, University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Urologist,

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: September 3, 2025
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)