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Completed

NCT Number: NCT06734429

Urinary Artificial Sphincter in Children

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?

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Key information

Conditions

Neurogenic Bladder Disorder Bladder Dysfunction Child, Only Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spina Bifida Spinal Dysraphism Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Incontinence Due to Urethral Sphincter Incompetence Urogenital Diseases Urologic Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urinary Artificial Sphincter

Other

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

Primary outcomes

  1. Number of participants with urinary sphincter incomptetence

    Time frame: Before surgery

    Participants with urinary incontinence caused by urinary sphincter incomptetence

  2. 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 (with or without a few leaks), the participant is continent with catheterization, the patient is incontinent.

Secondary outcomes

  1. 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.

  2. 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. Three outcomes are possible: the participant is continent, the participant is continent with catheterization, or the patient is incontinent.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Central Hospital, Nancy, France

Registry information

Official study title

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

Acronym: SUAPED

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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