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

NCT05982444 | Completed

• 1 other identifier: 30-2023
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms

Keywords

water vapor thermal therapy

Outcome Measures

Primary Outcomes (4)

• change in prostate volume

  Prostate volume will be measured via transrectal ultrasound.

  4 years

• hange in International Prostate Symptom Score (IPSS)

  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.

  4 years

• international index of erectile function (IIEF)

  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

  4 years

• Change in Post-Void Residual Urine

  Residual urine volume measured after urination using pelvic ultrasound.

  4 years

Secondary Outcomes (2)

• Retreatment Rate Following Rezūm Therapy

  4 years

• complication rate

  4 years

Study Arms (1)

patient treated by rezum procedure

OTHER

patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study

Procedure: water vapor thermal therapy (Rezum) for prostate

Interventions

water vapor thermal therapy (Rezum) for prostate PROCEDURE

all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period

Also known as: Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)

patient treated by rezum procedure

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: the disease is conclusive for men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Faculty of Medicine Helwan University

Helwan, Cairo Governorate, 11795, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Faculty of medicine

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 8, 2023
• Study Start: March 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)