Bladder Neck Surgery in Children With Neurogenic Bladder

Completed

• Conditions: Neurogenic Bladder; Incontinence, Urinary; Bladder Dysfunction; Spina Bifida

• Registration Number: NCT05861011
• Lead Sponsor: University of Lorraine

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: 2023-02-28
• Study First Submitted: 2023-04-13
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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	Baseline (Before surgery)	Cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck.; delayed or incomplete opening of the bladder neck
Number of participants with muscular bladder	Baseline (Before surgery)	The muscular bladder has thicker walls, bladder diverticula and trabecules (diagnosed during abdominal ultrasound, urethro-cystogram and cystoscopy)

Secondary Outcome Measures

Name	Time	Method
Length of stay	From admission to discharge home, up to 20 days	Length of stay
The time length between the surgery date and the postoperative consultation date	Through study completion, an average of 2 years	Follow_up represents the time length between the surgery date and the postoperative consultation date in days, months, or years. Generally, there are a-month-follow-up, a three month-follow-up, a six month-follow-up, and a year-follow-up. The surgeon can see the patient if there is any problem between these consultations. After a year of follow-up, it is up to the surgeon to decide if the patient needs to be seen yearly or not. The last follow-up date is crucial because it indicates how the patient is and if other follow-up dates need to be applied.
Surgical complications after bladder neck procedure	Through study completion, an average of 2 years	bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection
Operating time	Intraoperative	Operating time

Trial Locations

Locations (1)

ULorraine; 🇫🇷 Vandœuvre-lès-Nancy, Grand-Est, France