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

Primary Purpose

Pediatric Disorder, Hydronephrosis in Children, Hydronephrosis, Secondary

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Valve ablation

Valve ablation and bladder neck incision

About this trial

This is an interventional treatment trial for Pediatric Disorder focused on measuring PUV, BNI, Urethral valve, Valve ablation, Bladder dysfunction

Eligibility Criteria

undefined - 12 Years (Child)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Urology and nephrology center, Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Valve ablation

Valve ablation and bladder neck incision

Arm Description

Valve ablation

Valve ablation and bladder neck incision

Outcomes

Primary Outcome Measures

compare numbers of reintervention between groups

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05087537

First Posted

October 8, 2021

Last Updated

October 20, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05087537

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Disorder, Hydronephrosis in Children, Hydronephrosis, Secondary, Hydronephrosis Congenital, Bladder-Neck; Obstruction, Congenital, Urethral Valve, Renal Function Disorder

Keywords

PUV, BNI, Urethral valve, Valve ablation, Bladder dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Valve ablation

Arm Type

Active Comparator

Arm Description

Valve ablation

Arm Title

Valve ablation and bladder neck incision

Arm Type

Active Comparator

Arm Description

Valve ablation and bladder neck incision

Intervention Type

Procedure

Intervention Name(s)

Valve ablation

Intervention Description

Valve ablation

Intervention Type

Procedure

Intervention Name(s)

Valve ablation and bladder neck incision

Intervention Description

Valve ablation and bladder neck incision

Primary Outcome Measure Information:

Title

compare numbers of reintervention between groups

Description

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

Time Frame

1 year

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

males less than 12 years old

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Urology and nephrology center, Mansoura university

City

Mansoura

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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