Bladder Neck Surgery in Children With Neurogenic Bladder

NCT05861011 | Completed DMC

• 2 other identifiers: ULora2023PI004
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Incontinence, Urinary; Bladder Dysfunction; Spina Bifida; Neurogenic Bladder

Keywords

Bladder Neck Surgery; Children; Surgical Outcomes; Retrospective Study

Outcome Measures

Primary Outcomes (2)

• Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow

  Cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck. delayed or incomplete opening of the bladder neck

  Baseline (Before surgery)

• Number of participants with muscular bladder

  The muscular bladder has thicker walls, bladder diverticula and trabecules (diagnosed during abdominal ultrasound, urethro-cystogram and cystoscopy)

  Baseline (Before surgery)

Secondary Outcomes (4)

• Length of stay

  From admission to discharge home, up to 20 days

• The time length between the surgery date and the postoperative consultation date

  Through study completion, an average of 2 years

• Surgical complications after bladder neck procedure

  Through study completion, an average of 2 years

• Operating time

  Intraoperative

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neurogenic bladder

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lorraine: lead

Study Sites (1)

ULorraine

Vandœuvre-lès-Nancy, Grand Est, 54500, France

Location

Related Publications (1)

• Stein R, Bogaert G, Dogan HS, Hoen L, Kocvara R, Nijman RJM, Quaedackers J, Rawashdeh YF, Silay MS, Tekgul S, Radmayr C. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part II operative management. Neurourol Urodyn. 2020 Feb;39(2):498-506. doi: 10.1002/nau.24248. Epub 2019 Dec 3.

  PMID: 31794087 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Spinal Dysraphism; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Urinary Bladder Diseases

Study Officials

• Christelle Destinval, MD

  University of Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 16, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)