Urinary Artificial Sphincter in Children

NCT06734429 | Completed

• 1 other identifier: M24DC1105
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with urinary sphincter incomptetence

  Participants with urinary incontinence caused by urinary sphincter incomptetence

  Before surgery

• Impact of urinary artificial sphincter on the participants' incontinence

  Three outcomes are possible: the participant is continent (with or without a few leaks), the participant is continent with catheterization, the patient is incontinent.

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• Impact of bladder augmentation on participants' incontinence

  Through study completion, an average of 2 years

• Impact of Mitrofanoff procedure on participants' incontinence

  Through study completion, an average of 2 years

• Impact of bladder neck surgery on participants' incontinence

  Through study completion, an average of 2 years

• Last follow-up

  Through study completion, an average of 2 years]

Study Arms (1)

Urinary Artificial Sphincter (UAS) in Children

Patients aged under 18 years old with UAS

Other: Urinary Artificial Sphincter

Interventions

Urinary Artificial Sphincter OTHER

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

Urinary Artificial Sphincter (UAS) in Children

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients younger than 18 years old who have neurogenic bladders

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Central Hospital, Nancy, France: collaborator

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 35340070 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Dysraphism

Interventions

Urinary Sphincter, Artificial

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: November 20, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)