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NCT05087537 Clinical Trial

Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve

Pediatric Disorder Clinical Trial

Official title:
Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve : A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05087537
Other study ID # PUV , BNI
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date January 1, 2023

Study information
Verified date October 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 62
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender Male
Age group N/A to 12 Years
Eligibility Inclusion Criteria: - Patients who are less than 12 years of age with presenting to the Mansoura University Urology and Nephrology Center with the diagnosis of PUV will be s creended for eligibility Exclusion Criteria: - Patients with other conditions that can potentially affect lower and upper urinary tract functions - Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy. - Patients who had primary treatment of posterior urethral valve ablation at other hospitals.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Valve ablation
Valve ablation
• Valve ablation and bladder neck incision
Valve ablation and bladder neck incision

Locations
Country Name City State
Egypt Urology and nephrology center, Mansoura university Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary compare numbers of reintervention between groups assessed by calculating the number of patients needed surgical reintervention per total number of patients in both groups 1 year
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