Urinary Artificial Sphincter in Children

Child, Only Clinical Trial

— SUA  

Official title:

Place of Urinary Artificial Sphincter in Children With Neurogenic Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858840
• Other study ID #: ULorr
• Secondary ID: 2023PI008
• Status: Completed
• Start date: November 20, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: May 2023
• Source: University of Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 10, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Dysfunction
• Child, Only
• Neurogenic Bladder
• Spina Bifida
• Spinal Dysraphism
• Urinary Bladder, Neurogenic

Intervention

Other:
• Urinary Artificial Sphincter (UAS) in Children
Patients aged under 18 years old with UAS

Locations

Country	Name	City	State
France	ULorraine	Vandœuvre-lès-Nancy	Grand-Est

Sponsors (1)

Lead Sponsor	Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with refractory urinary incontinence	Participants with urinary incontinence without response to medical treatment or catheterization	Before surgery
Primary	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	Impact of bladder augmentation on participants' incontinence	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.	Through study completion, an average of 2 years
Secondary	Impact of Mitrofanoff procedure on participants' incontinence	Analysing the presence of Mitrofanoff procedure 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.	Through study completion, an average of 2 years
Secondary	Impact of bladder neck surgery on participants' incontinence	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.	Through study completion, an average of 2 years
Secondary	Complications after urinary artificial sphincter	Medical and surgical complications after urinary artificial sphincter	Through study completion, an average of 2 years
Secondary	Operating time	Operating time	Perioperatively
Secondary	Length of stay	Length of stay	From the day of hospitalization to the day of discharge home, up to 20 days
Secondary	Last follow-up	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.	Through study completion, an average of 2 years