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Urinary Artificial Sphincter in Children

Management of Patients Who Had an Artificial Urethral Sphincter by Laparotomy in Childhood

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06734429
Acronym
SUAPED
Enrollment
15
Registered
2024-12-16
Start date
2022-11-20
Completion date
2023-01-31
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Dysfunction, Child, Only, Neurogenic Bladder Disorder, Spina Bifida, Urinary Incontinence Due to Urethral Sphincter Incompetence

Keywords

Urinary Artificial Sphincter, Neurogenic Bladder, Child, Outcomes, Retrospective Study

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 wanted to analyze the participants' data, which led to the indication of a urinary artificial sphincter and its outcomes.

Interventions

OTHERUrinary Artificial Sphincter

Urinary Artificial Sphincter is a device used for patients with urethral sphincter incompetence

Sponsors

Central Hospital, Nancy, France
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with urinary sphincter incomptetenceBefore surgeryParticipants with urinary incontinence caused by urinary sphincter incomptetence
Impact of urinary artificial sphincter on the participants' incontinenceThrough study completion, an average of 2 yearsThree outcomes are possible: the participant is continent (with or without a few leaks), the participant is continent with catheterization, the patient is incontinent.

Secondary

MeasureTime frameDescription
Impact of bladder augmentation on participants' incontinenceThrough study completion, an average of 2 yearsAnalysing 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 Mitrofanoff procedure on participants' incontinenceThrough study completion, an average of 2 yearsAnalysing the presence of Mitrofanoff procedure 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' incontinenceThrough study completion, an average of 2 yearsAnalysing 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.
Last follow-upThrough 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026