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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Function Disorder; Pediatric Disorder; Hydronephrosis, Secondary; Hydronephrosis in Children; Hydronephrosis Congenital; Bladder-Neck; Obstruction, Congenital; Urethral Valve
• Intervention / Treatment: Procedure: Valve ablation; Procedure: Valve ablation and bladder neck incision

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Urology and nephrology center, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Valve ablation	Procedure: Valve ablation; Valve ablation
Active Comparator: Valve ablation and bladder neck incision	Procedure: Valve ablation and bladder neck incision; Valve ablation and bladder neck incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Bladder dysfunction; BNI; PUV; Urethral valve; Valve ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Disease; Urinary Bladder Neck Obstruction; Hydronephrosis
• Other Study ID Numbers: PUV , BNI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No