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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

NCT ID: NCT05087537

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-01-01

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Valve ablation

Valve ablation

Group Type ACTIVE_COMPARATOR

Valve ablation

Intervention Type PROCEDURE

Valve ablation

Valve ablation and bladder neck incision

Valve ablation and bladder neck incision

Group Type ACTIVE_COMPARATOR

Valve ablation and bladder neck incision

Intervention Type PROCEDURE

Valve ablation and bladder neck incision

Interventions

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Valve ablation

Valve ablation

Intervention Type PROCEDURE

Valve ablation and bladder neck incision

Valve ablation and bladder neck incision

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology and nephrology center, Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PUV , BNI

Identifier Type: -

Identifier Source: org_study_id