Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
East Coast Institute for Research
Jacksonville, Florida, United States
Change From Baseline for HRQL Total Score
The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is.
Time frame: 3 months
Change From Baseline in CCIS Score
The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is.
Time frame: 3 months
Change From Baseline in the Number of CISC/Day
Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline.
Time frame: 3 months
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Florida Urology Partners
Tampa, Florida, United States
First Urology
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Saint Elizabeth Healthcare
Edgewood, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, United States
Ochsner Medical Center
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Minnesota Urology (Woodbury)
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Montefiore Medical Center
The Bronx, New York, United States
The Christ Hospital
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