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Urinary Artificial Sphincter in Children

NCT ID: NCT06734429

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-20

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Urinary Artificial Sphincter Neurogenic Bladder Child Outcomes Retrospective Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Urinary Artificial Sphincter (UAS) in Children

Patients aged under 18 years old with UAS

Urinary Artificial Sphincter

Intervention Type OTHER

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

Interventions

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Urinary Artificial Sphincter

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Destinval Christelle

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

References

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Delgado-Miguel C, Munoz-Serrano A, Amesty V, Rivas S, Lobato R, Martinez-Urrutia MJ, Lopez-Pereira P. Artificial urinary sphincter in congenital neuropathic bladder: Very long-term outcomes. Int J Urol. 2022 Jul;29(7):692-697. doi: 10.1111/iju.14874. Epub 2022 Mar 26.

Reference Type BACKGROUND
PMID: 35340070 (View on PubMed)

Other Identifiers

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M24DC1105

Identifier Type: -

Identifier Source: org_study_id