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Completed

NCT Number: NCT05861011

Bladder Neck Surgery in Children With Neurogenic Bladder

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

Consequences on bladder voiding.

Completed

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Key information

Conditions

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

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ULorraine

Vandœuvre-lès-Nancy, Grand Est, 54500, 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

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: 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

  2. Number of participants with muscular bladder

    Time frame: Baseline (Before surgery)

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

Secondary outcomes

  1. Length of stay

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

    Length of stay

  2. The time length between the surgery date and the postoperative consultation date

    Time frame: 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.

  3. Surgical complications after bladder neck procedure

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

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

  4. Operating time

    Time frame: Intraoperative

    Operating time

Sponsors and collaborators

Lead sponsor

University of Lorraine

Other

Registry information

Official study title

Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study

Acronym: CERPED

Important dates

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

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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