SUA: Urinary Artificial Sphincter in Children

• Sponsor: University of Lorraine (Other)
• Overall Status: Completed
• CT.gov ID: NCT05858840
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder; Bladder Dysfunction; Spina Bifida; Child, Only	Other: Urinary Artificial Sphincter (UAS) in Children

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Place of Urinary Artificial Sphincter in Children With Neurogenic Bladder
• Actual Study Start Date: Nov 20, 2022
• Actual Primary Completion Date: Jan 31, 2023
• Actual Study Completion Date: Apr 10, 2023

Outcome Measures

Primary Outcome Measures

1. Number of participants with refractory urinary incontinence [Before surgery]

   Participants with urinary incontinence without response to medical treatment or catheterization

2. Impact of urinary artificial sphincter on the participants' incontinence [Through study completion, an average of 2 years]

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

Secondary Outcome Measures

1. Impact of bladder augmentation on participants' incontinence [Through study completion, an average of 2 years]

   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.

2. Impact of Mitrofanoff procedure on participants' incontinence [Through study completion, an average of 2 years]

   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.

3. Impact of bladder neck surgery on participants' incontinence [Through study completion, an average of 2 years]

   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.

4. Complications after urinary artificial sphincter [Through study completion, an average of 2 years]

   Medical and surgical complications after urinary artificial sphincter

5. Operating time [Perioperatively]

   Operating time

6. Length of stay [From the day of hospitalization to the day of discharge home, up to 20 days]

   Length of stay

7. Last follow-up [Through study completion, an average of 2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ULorraine	Vandœuvre-lès-Nancy	Grand-Est	France	54500

Sponsors and Collaborators

• University of Lorraine

Investigators

• Principal Investigator: Christelle Destinval, MD, University of Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine
• ClinicalTrials.gov Identifier: NCT05858840
• Other Study ID Numbers: ULorr; 2023PI008
• First Posted: May 15, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine: Urinary Artificial Sphincter; Neurogenic Bladder; Children; Outcomes; Retrospective Study
• Additional relevant MeSH terms: Urinary Bladder, Neurogenic; Spinal Dysraphism

Study Results

No Results Posted as of May 16, 2023