Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms

• Registration Number: NCT05982444
• Lead Sponsor: Helwan University

Brief Summary

This study aims to assess the effectiveness and morbidity of water vapor thermal therapy (Rezūm therapy) for benign prostatic hyperplasia (BPH). Data will be collected and analyzed from patients treated by Rezūm and followed up for 4 years prior to evaluating clinical outcomes.

Detailed Description

The investigators will conduct a retrospective study evaluating patients treated with water vapor thermal therapy (Rezūm therapy) for BPH and followed up for4 years. The primary objectives are to assess the long-term effectiveness and morbidity rates associated with the procedure. Data collected will include urinary symptom scores, sexual function, and any treatment-related complications.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-08
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

Inclusion Criteria

• patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years

Exclusion Criteria

• previous prostatic intervention
• concurrent urological morbidity like urethral stricture
• neurological disease like parkinson's disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in prostate volume	4 years	Prostate volume will be measured via transrectal ultrasound.
hange in International Prostate Symptom Score (IPSS)	4 years	IPSS is a questionnaire evaluating urinary symptoms. Scores ranging from 0 to 7 indicate mild symptoms, from 8 to 19 moderate symptoms, and from 20 to 35 severe symptoms.
international index of erectile function (IIEF)	4 years	IIEF is a questionnaire evaluating sexual function. Scores ranging from 5 to 7 indicate severe symptoms, 8 to 11 moderate symptoms, 12 to 16 mild to moderate symptoms, 17 to 21 mild symptoms, and 22 to 25 no erectile dysfunction
Change in Post-Void Residual Urine	4 years	Residual urine volume measured after urination using pelvic ultrasound.

Secondary Outcome Measures

Name	Time	Method
Retreatment Rate Following Rezūm Therapy	4 years	Number of participants requiring additional treatment for BPH after Rezūm therapy.
complication rate	4 years	incidence of complications post procedure during follow-up

Trial Locations

Locations (1)

Faculty of Medicine Helwan University; 🇪🇬 Helwan, Cairo, Egypt