Bladder Neck Surgery in Children With Neurogenic Bladder (CERPED)

May 15, 2023 updated by: Dr Christelle DESTINVAL, University of Lorraine

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

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

Consequences on bladder voiding.

Study Overview

Status

Completed

Conditions

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)

48

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

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: 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
Baseline (Before surgery)
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)
Baseline (Before surgery)

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
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.
Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
Operating time
Time Frame: Intraoperative
Operating time
Intraoperative

Collaborators and Investigators

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

Sponsor

University of Lorraine

Investigators

  • Principal Investigator: Christelle Destinval, MD, University of Lorraine

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)

February 28, 2023

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULora
  • 2023PI004 (Registry Identifier: DRCI)

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

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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