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 |
|---|---|---|
|
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
- 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: