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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Device: Rezum Water Vapor Thermal Therapy

Detailed Description

Benign prostatic hyperplasia (BPH) is a common condition in aging men and is a major cause of lower urinary tract symptoms (LUTS), including urinary frequency, urgency, nocturia, weak urinary stream, intermittency, hesitancy, and incomplete bladder emptying. Although transurethral resection of the prostate (TURP) has historically been considered the standard surgical treatment, it may be associated with bleeding, retrograde ejaculation, erectile dysfunction, incontinence, and the need for spinal or general anesthesia. Minimally invasive surgical therapies such as Rezūm water vapor thermal therapy (WVTT) have emerged as alternatives for selected patients.

This retrospective observational study was conducted at the Department of Urology, Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq, between September 3, 2025, and March 12, 2026. The study includes 129 consecutive male patients aged 45 years or older with moderate-to-severe LUTS secondary to BPH, including patients with prostate volumes between 30 and 120 grams, those who failed or were intolerant to medical therapy, and selected patients with catheter-dependent urinary retention related to BPH.

All patients underwent preoperative evaluation including medical history, physical examination, digital rectal examination, International Prostate Symptom Score (IPSS), quality of life assessment, International Index of Erectile Function (IIEF), prostate-specific antigen testing, renal function tests, urinalysis, urine culture, uroflowmetry, post-void residual measurement, prostate imaging, and cystoscopic assessment. Selected patients with possible neurogenic bladder dysfunction underwent urodynamic testing when indicated.

All procedures were performed using the Rezūm System under local anesthesia with intravenous sedation. Treatment details, including number and location of injections, were determined according to prostate anatomy and size. Postoperatively, all patients received urethral catheterization for a duration based on prostate size, antibiotic prophylaxis, and alpha-blocker therapy.

Primary outcome measures include changes in IPSS, maximum urinary flow rate (Qmax), post-void residual volume (PVR), quality of life score, erectile function, and prostate volume reduction at follow-up. Secondary outcome measures include intraoperative and postoperative complications, catheter duration, discharge time, urinary retention after catheter removal, urinary tract infection, hematuria, sexual side effects, and need for retreatment or alternative surgical intervention.

The purpose of this study is to assess the safety, feasibility, and short-term effectiveness of Rezūm therapy performed under local anesthesia with intravenous sedation in a real-world clinical setting, including patients with significant comorbidities and larger prostate volumes.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region of Iraq (kri)
    • Sulaymaniyah, Kurdistan Region of Iraq (kri), Iraq, 46001
      • Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Male patients aged 45 years or older.
2. Moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia (IPSS ≥8).
3. Maximum urinary flow rate (Qmax) less than 15 mL/s on uroflowmetry.
4. Prostate volume 30 to 120 g on transrectal or transabdominal ultrasonography.
5. Failure of medical therapy or intolerance to medical therapy.
6. Catheter-dependent urinary retention secondary to benign prostatic hyperplasia in patients who were not candidates for or declined conventional surgical intervention.
7. Consecutive patients who underwent Rezūm water vapor thermal therapy during the study period.

Exclusion Criteria:

1. Pre-existing erectile dysfunction not attributable to benign prostatic hyperplasia medication side effects.
2. Retrograde ejaculation not caused by alpha-blocker therapy.
3. Lower urinary tract symptoms attributable to causes other than benign prostatic hyperplasia, including neurogenic bladder or bladder overactivity unrelated to benign prostatic hyperplasia.
4. History of previous bladder surgery, prostate surgery, or urethral stricture surgery.
5. Presence of vesical calculi.
6. Confirmed neurogenic bladder.
7. Suspected or confirmed prostate malignancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Transurethral convective water vapor thermal therapy used for the treatment of benign prostatic hyperplasia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative and Postoperative Complications	Assessment of complications including hematuria, urinary tract infection, urinary retention, urgency, frequency, nocturia, urge incontinence, and other treatment-related adverse events.	From procedure date to 3 months
Catheterization Duration	Duration of postoperative urethral catheterization following Rezūm treatment.	From procedure date until catheter removal, up to 12 days
Hospital Discharge Time	Time from completion of the procedure to discharge from hospital.	Day of procedure to next day
Retreatment or Conversion to Alternative Surgery	Need for repeat Rezūm treatment or conversion to alternative surgical procedures such as laser ablation or bipolar transurethral resection of the prostate.	Up to 3 months
Incidence of Retrograde Ejaculation	Number of patients reporting retrograde ejaculation after Rezūm treatment.	From procedure date to 3 months
Incidence of De Novo Erectile Dysfunction	Number of patients with new-onset erectile dysfunction after treatment.	From procedure date to 3 months

Collaborators and Investigators

• Sponsor: ALI KAMAL M. SAMI
• Investigators: Principal Investigator: Ali K M.Sami, M.B.Ch.B., F.I.B.M.S.( PhD), College of Medicine, University of Sulaimani

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Actual): March 12, 2026
• Study Completion (Actual): March 12, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; LUTS; BPH; Urinary Retention; Local Anesthesia; Rezum; Prostate Enlargement; Intravenous Sedation; Minimally Invasive Therapy; Water Vapor Thermal Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Retention
• Other Study ID Numbers: 21022023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data will not be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No