Clinical trial NCT05858840: Urinary Artificial Sphincter in Children
Official title: Place of Urinary Artificial Sphincter in Children With Neurogenic Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder
Bladder Dysfunction
Spina Bifida
Child, Only
Keywords: Urinary Artificial Sphincter
Neurogenic Bladder
Children
Outcomes
Retrospective Study
Lead sponsor: University of Lorraine
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 17
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients younger than 18 years old who have neurogenic bladders.

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 want to analyse the participants data, that led to indication of an urinary artificial sphincter, and its outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with refractory urinary incontinence
timeFrame: Before surgery
measure: Impact of urinary artificial sphincter on the participants' incontinence
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Impact of bladder augmentation on participants' incontinence
timeFrame: Through study completion, an average of 2 years
measure: Impact of Mitrofanoff procedure on participants' incontinence
timeFrame: Through study completion, an average of 2 years
measure: Impact of bladder neck surgery on participants' incontinence
timeFrame: Through study completion, an average of 2 years
measure: Complications after urinary artificial sphincter
timeFrame: Through study completion, an average of 2 years
measure: Operating time
timeFrame: Perioperatively
measure: Length of stay
timeFrame: From the day of hospitalization to the day of discharge home, up to 20 days
measure: Last follow-up
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: ULorraine
state: Grand-Est
Study officials:
affiliation: University of Lorraine
name: Christelle Destinval, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.