Bladder Neck Surgery in Children with Neurogenic Bladder (CERPED)

December 11, 2024 updated by: Destinval Christelle, University Hospital, Clermont-Ferrand

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63003
        • University Hospital, Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with neurogenic bladder

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before surgery
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
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: From admission to discharge home, up to 20 days
Length of stay
From admission to discharge home, up to 20 days
Complications after bladder neck procedure
Time Frame: Through study completion, an average of 2 years
bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24DC1103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the name of anonymization, the investigators won't share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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