Urinary Artificial Sphincter in Children

Completed

• Conditions: Neurogenic Bladder; Bladder Dysfunction; Spina Bifida; Child, Only

• Registration Number: NCT05858840
• Lead Sponsor: University of Lorraine

Brief Summary

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.

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 Timeline

• Study Start: 2022-11-20
• Primary Completion: 2023-01-31
• Study Completion: 2023-04-10
• Study First Submitted: 2023-04-12
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-14
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with refractory urinary incontinence	Before surgery	Participants with urinary incontinence without response to medical treatment or catheterization
Impact of urinary artificial sphincter on the participants' incontinence	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.

Secondary Outcome Measures

Name	Time	Method
Operating time	Perioperatively	Operating time
Length of stay	From the day of hospitalization to the day of discharge home, up to 20 days	Length of stay
Impact of bladder augmentation on participants' incontinence	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.
Impact of bladder neck surgery on participants' incontinence	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.
Complications after urinary artificial sphincter	Through study completion, an average of 2 years	Medical and surgical complications after urinary artificial sphincter
Impact of Mitrofanoff procedure on participants' incontinence	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.
Last follow-up	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.

Trial Locations

Locations (1)

ULorraine; 🇫🇷 Vandœuvre-lès-Nancy, Grand-Est, France