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

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05087537
Collaborator
(none)
62
1
2
15
4.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Valve ablation
  • Procedure: Valve ablation and bladder neck incision
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Valve ablation

Valve ablation

Procedure: Valve ablation
Valve ablation

Active Comparator: Valve ablation and bladder neck incision

Valve ablation and bladder neck incision

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

Outcome Measures

Primary Outcome Measures

  1. compare numbers of reintervention between groups [1 year]

    assessed by calculating the number of patients needed surgical reintervention per total number of patients in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology and nephrology center, Mansoura university Mansoura Dakahlia Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05087537
Other Study ID Numbers:
  • PUV , BNI
First Posted:
Oct 21, 2021
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mansoura University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021