Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, INS Model 4101. The product is currently marketed under the name F15.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).
Hartford Healthcare
Waterford, Connecticut, United States
Florida Gulf Clinical Research
Bradenton, Florida, United States
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Time frame: 3 months
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Time frame: 3 months
Adverse event reporting (Safety)
Device-related, procedure-related and all serious adverse events
Time frame: 3 months
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Time frame: 1 year
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
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East Coast Institute of Research
Jacksonville, Florida, United States
Florida Bladder Institute
Naples, Florida, United States
Atrium Health
Macon, Georgia, United States
Minnesota Urology
Coon Rapids, Minnesota, United States
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
The Oregon Clinic
Portland, Oregon, United States
Southern Shores Urogynecology
Myrtle Beach, South Carolina, United States
...and 6 more locations
Time frame: 1 year
Performance/Effectiveness - Improvement in Quality of Life Survey (FI)
Fecal Incontinence Quality of Life (FIQoL): includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
Time frame: 3 months, 6 months, 1 year
Adverse event reporting (Safety)
Device-related, procedure-related and all serious adverse events
Time frame: 1 year