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

Not Applicable

Active, not recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: water vapor thermal therapy (Rezum) for prostate

• Registration Number: NCT05982444
• Lead Sponsor: Helwan University

Brief Summary

in this study the investigators are assessing the effectiveness and morbidity of rezum therapy for benign prostatic hyperplasia by collect data and assess all patient who treated by rezum from 2 to 4 years and report these results.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-07-24
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 50

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

Arm && Interventions

Group	Intervention	Description
patient treated by rezum procedure	water vapor thermal therapy (Rezum) for prostate	patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study

Primary Outcome Measures

Name	Time	Method
prostate assessment	4 years	assess prostate volume and post voiding residual by pelvi-abdominal ultrasound
symptoms assessment	4 years	assess International Prostate Symptom Score (IPSS) from 0 to 7 mild symptoms - from 8 to 19 moderate symptoms and from 20 to 35 sever symptoms
sexual function	4 years	assess international index of erectile function ( IIEF-5) score (5-7) severe - (8-11) moderate - (12-16) mild to moderate - (17-21) mild - (22-25) no erectile dysfunction

Secondary Outcome Measures

Name	Time	Method
durability of procedure	4 years	incidence of prostate retreatment by the same or other procedure.
complication of procedure	4 years	incidence of urological complications (e.g. urine retention, urethral stricture and hematuria) happen during follow up

Trial Locations

Locations (1)

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