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

NCT ID: NCT05982444

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2025-05-01

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patient treated by rezum procedure

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

Group Type: OTHER

water vapor thermal therapy (Rezum) for prostate

Intervention Type: PROCEDURE

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

Interventions

water vapor thermal therapy (Rezum) for prostate

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

Intervention Type: PROCEDURE

Other Intervention Names

Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mohammed Elsaid Ali Elshahawy

Principal Investigator, Faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Helwan University

Helwan, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

30-2023

Identifier Type: -

Identifier Source: org_study_id