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NCT05982444 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05982444
Other study ID # 30-2023
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 2023

Study information
Verified date August 2023
Source Helwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• water vapor thermal therapy (Rezum) for prostate
all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period

Locations
Country Name City State
Egypt Faculty of Medicine Helwan University Helwan Cairo

Sponsors (1)
Lead Sponsor Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary prostate assessment assess prostate volume and post voiding residual by pelvi-abdominal ultrasound 4 years
Primary symptoms assessment 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 4 years
Primary sexual function 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 4 years
Secondary durability of procedure incidence of prostate retreatment by the same or other procedure. 4 years
Secondary complication of procedure incidence of urological complications (e.g. urine retention, urethral stricture and hematuria) happen during follow up 4 years
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