An observational study in Neurogenic Bladder Disorder, Bladder Dysfunction and Spina Bifida, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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?
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 wanted to analyze the participants' data, which led to the indication of a urinary artificial sphincter and its outcomes.
189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's enrollment of 15 is below the median of 71 across 57 observational studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients younger than 18 years old who have neurogenic bladders
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients aged under 18 years old with UAS
Other: Urinary Artificial Sphincter
Urinary Artificial Sphincter is a device used for patients with urethral sphincter incompetence
Number of participants with urinary sphincter incomptetence
Participants with urinary incontinence caused by urinary sphincter incomptetence
Time frame: 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.
Time frame: Through study completion, an average of 2 years
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.
Time frame: Through study completion, an average of 2 years
Impact of Mitrofanoff procedure on participants' incontinence
Analysing the presence of Mitrofanoff procedure 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.
Time frame: Through study completion, an average of 2 years
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.
Time frame: Through study completion, an average of 2 years
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.
Time frame: Through study completion, an average of 2 years]
Plan to share: No — In the name of anonymization the investigators won't share individual participant data
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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