Urinary Artificial Sphincter in Children (SUA)

May 14, 2023 updated by: Dr Christelle DESTINVAL, University of Lorraine

Place of Urinary Artificial Sphincter in Children With Neurogenic Bladder

Retrospective monocentric study of the outcomes of patients with neurogenic bladder, who had a urinary artificial sphincter before the age of 18 years old.

Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The management of patients with neurogenic bladder is complex. Several patients have been operated multiple times. Surgical procedures such as Mitrofanoff's, bladder neck surgery, bladder augmentation and urinary artificial sphincter, are common.

The investigators want to analyse the participants data, that led to indication of an urinary artificial sphincter, and its outcomes.

Study Type

Observational

Enrollment (Actual)

17

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 younger than 18 years old who have neurogenic bladders.

Description

Inclusion Criteria:

  • Patients who were younger than 18 years old when they had an urinary artificial sphincter

Exclusion Criteria:

  • Patients who were 18 years old or older when they had an urinary artificial sphincter

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 refractory urinary incontinence
Time Frame: Before surgery
Participants with urinary incontinence without response to medical treatment or catheterization
Before surgery
Impact of urinary artificial sphincter on the participants' incontinence
Time Frame: Through study completion, an average of 2 years
Three outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of bladder augmentation on participants' incontinence
Time Frame: Through study completion, an average of 2 years
Analysing the presence of bladder augmentation in participants with urinary artificial sphincter. Three outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.
Through study completion, an average of 2 years
Impact of Mitrofanoff procedure on participants' incontinence
Time Frame: Through study completion, an average of 2 years
Analysing the presence of Mitrofanoff procedure in participants with urinary artificial sphincter. hree outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.
Through study completion, an average of 2 years
Impact of bladder neck surgery on participants' incontinence
Time Frame: Through study completion, an average of 2 years
Analysing the presence of bladder neck surgery in participants with urinary artificial sphincter. hree outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.
Through study completion, an average of 2 years
Complications after urinary artificial sphincter
Time Frame: Through study completion, an average of 2 years
Medical and surgical complications after urinary artificial sphincter
Through study completion, an average of 2 years
Operating time
Time Frame: Perioperatively
Operating time
Perioperatively
Length of stay
Time Frame: From the day of hospitalization to the day of discharge home, up to 20 days
Length of stay
From the day of hospitalization to the day of discharge home, up to 20 days
Last follow-up
Time Frame: Through study completion, an average of 2 years
Follow-up represents the time between the surgery and postoperative consultation dates 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

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)

November 20, 2022

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULorr
  • 2023PI008 (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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