NCT05087537

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

October 8, 2021

Last Update Submit

October 20, 2021

Conditions

Pediatric DisorderHydronephrosis in ChildrenHydronephrosis, SecondaryHydronephrosis CongenitalBladder-Neck; Obstruction, CongenitalUrethral ValveRenal Function Disorder

Keywords

PUVBNIUrethral valveValve ablationBladder dysfunction

Outcome Measures

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

    1 year

Study Arms (2)

Valve ablation

ACTIVE COMPARATOR

Valve ablation

Procedure: Valve ablation

Valve ablation and bladder neck incision

ACTIVE COMPARATOR

Valve ablation and bladder neck incision

Procedure: Valve ablation and bladder neck incision

Interventions

Valve ablationPROCEDURE

Valve ablation

Valve ablation
Valve ablation and bladder neck incisionPROCEDURE

Valve ablation and bladder neck incision

Valve ablation and bladder neck incision

Eligibility Criteria

AgeUp to 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales less than 12 years old
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center, Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

HydronephrosisNeoplasm MetastasisBites and Stings

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 21, 2021

Study Start

October 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 25, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)