Bladder Neck Surgery in Children with Neurogenic Bladder

Completed

• Conditions: Incontinence; Bladder Dysfunction; Spina Bifida; Neurogenic Bladder Disorder; Child, Only

• Registration Number: NCT06734390
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.

Detailed Description

Surgical outcomes of bladder neck surgery in children with neurogenic bladder:

Quality of voiding: spontaneous, need for catheterization, or incontinence. Other surgical complications.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2023-01-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Patients with neurogenic bladder and younger than 18 years old , who underwent a bladder neck procedure

Exclusion Criteria

• Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow	Before surgery	Abdominal ultrasound, cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck.
Long-term urinary continence	Through study completion, an average of 2 years	Reporting if the patients are dry or need catheterizations or protections

Secondary Outcome Measures

Name	Time	Method
Length of stay	From admission to discharge home, up to 20 days	Length of stay
Complications after bladder neck procedure	Through study completion, an average of 2 years	bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection
Follow-up	Through study completion, an average of 2 years	The time length between the surgery date and the postoperative consultation date.; Follow-up represents the time between the surgery and postoperative consultation dates in days, months, or years.

Trial Locations

Locations (1)

University Hospital, Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France