Management of Patients Who Had an Artificial Urethral Sphincter by Laparotomy in Childhood
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of participants with urinary sphincter incomptetence
Study Overview
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 wanted to analyze the participants' data, which led to the indication of a urinary artificial sphincter and its outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 0 Years to 17 Years (Child)
- Sex
- 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
Outcomes
Primary Outcomes
Number of participants with urinary sphincter incomptetence
Time Frame: Before surgery
Participants with urinary incontinence caused by urinary sphincter incomptetence
Impact of urinary artificial sphincter on the participants' incontinence
Time Frame: Through study completion, an average of 2 years
Three outcomes are possible: the participant is continent (with or without a few leaks), the participant is continent with catheterization, the patient is incontinent.
Secondary Outcomes
- 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)
- Last follow-up(Through study completion, an average of 2 years])
Investigators
Destinval Christelle
Dr.
University Hospital, Clermont-Ferrand