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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Disease
• Hydronephrosis
• Hydronephrosis in Children
• Hydronephrosis, Secondary
• Pediatric Disorder
• Renal Function Disorder
• Urinary Bladder Neck Obstruction

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