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Status unknownNCT05087537Updated Oct 25, 2021

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

An interventional study of Valve ablation and Valve ablation and bladder neck incision in Pediatric Disorder, Hydronephrosis in Children and Hydronephrosis, Secondary, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to male participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
Up to 12 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • 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
03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

This study's planned enrollment of 62 is below the median of 100 across 23 interventional studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Mansoura University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Active comparator
    Valve ablation

    Valve ablation

    Procedure: Valve ablation

  • Active comparator
    Valve ablation and bladder neck incision

    Valve ablation and bladder neck incision

    Procedure: Valve ablation and bladder neck incision

Interventions

  • ProcedureValve ablation

    Valve ablation

  • ProcedureValve ablation and bladder neck incision

    Valve ablation and bladder neck incision

06

What researchers measure

Primary outcomes

  1. compare numbers of reintervention between groups

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

    Time frame: 1 year

07

Study locations

1 site
  • Urology and nephrology center, Mansoura university
    Mansoura, Dakahlia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05087537
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Oct 21, 2021
Start date
Oct 1, 2021
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Oct 25, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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