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Completed

NCT Number: NCT06734390

Bladder Neck Surgery in Children with Neurogenic Bladder

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

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Key information

Conditions

Incontinence Bladder Dysfunction Child, Only Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurogenic Bladder Disorder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spina Bifida Spinal Dysraphism Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder Neck Surgery

Other

Bladder Neck Surgery regroups many surgical procedures to cure urinary incontinence.

Primary outcomes

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

    Time frame: Before surgery

    Abdominal ultrasound, cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck.

  2. Long-term urinary continence

    Time frame: Through study completion, an average of 2 years

    Reporting if the patients are dry or need catheterizations or protections

Secondary outcomes

  1. Length of stay

    Time frame: From admission to discharge home, up to 20 days

    Length of stay

  2. Complications after bladder neck procedure

    Time frame: Through study completion, an average of 2 years

    bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection

  3. Follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Management of Patients Under 18 Years of Age Who Have Had Bladder Neck Procedures

Acronym: CERPED

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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