Urinary Artificial Sphincter in Children

NCT05858840 | Completed

• 2 other identifiers: ULorr2023PI008
• Study Type: observational
• Target: 17
• 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; Bladder Dysfunction; Spina Bifida; Child, Only

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with refractory urinary incontinence

  Participants with urinary incontinence without response to medical treatment or catheterization

  Before surgery

• Impact of urinary artificial sphincter on the participants' incontinence

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

  Through study completion, an average of 2 years

Secondary Outcomes (7)

• 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

• Complications after urinary artificial sphincter

  Through study completion, an average of 2 years

• Operating time

  Perioperatively

Interventions

Urinary Artificial Sphincter (UAS) in Children OTHER

Patients aged under 18 years old with UAS

Eligibility Criteria

• Age: Up to 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 of Lorraine: lead

Study Sites (1)

ULorraine

Vandœuvre-lès-Nancy, Grand Est, 54500, France

Location

Related Publications (2)

• 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

• Sheppard KE, Roberts JL, Blum M. Adrenocorticotropin-releasing factor down-regulates glucocorticoid receptor expression in mouse corticotrope tumor cells via an adenylate cyclase-dependent mechanism. Endocrinology. 1991 Aug;129(2):663-70. doi: 10.1210/endo-129-2-663.

  PMID: 1855464 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 Officials

• Christelle Destinval, MD

  University of Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 15, 2023
• Study Start: November 20, 2022
• Primary Completion: January 31, 2023
• Study Completion: April 10, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)