F15 Recharge Free Axonics SNM System Clinical Study
- Conditions
- Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Fecal Incontinence (FI)
- Interventions
- Device: Axonics SNM System (Model 4101)
- Registration Number
- NCT06186765
- Lead Sponsor
- Axonics, Inc.
- Brief Summary
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.
- Detailed Description
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, model 4101. The product is currently marketed under the name F15 in the United States.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 18 years or older
- Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
- Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
- Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
- Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
- Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm - product does not have Communauté Européenne (CE) Mark in Europe Axonics SNM System (Model 4101) Observational
- Primary Outcome Measures
Name Time Method Performance/Effectiveness - Improvement in Quality of Life scoring (OAB) 3 months 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.
Performance/Effectiveness - Improvement in Fecal Incontinence Survey 3 months 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.
Performance/Effectiveness - Improvement in Quality of Life scoring (FI) 3 months 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.
Adverse event reporting (Safety) 3 months Device-related, procedure-related and all serious adverse events
- Secondary Outcome Measures
Name Time Method Performance/Effectiveness - Improvement in Quality of Life scoring (OAB) 1 year 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.
Performance/Effectiveness - Improvement in Fecal Incontinence Survey 1 year 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.
Performance/Effectiveness - Improvement in Quality of Life Survey (FI) 1 year 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.
Adverse event reporting (Safety) 1 year Device-related, procedure-related and all serious adverse events
Trial Locations
- Locations (14)
Bristol Urological Institute
🇬🇧Bristol, United Kingdom
Hartford Healthcare
🇺🇸Waterford, Connecticut, United States
Manatee Medical Research Institute
🇺🇸Bradenton, Florida, United States
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
Houston Colon
🇺🇸Houston, Texas, United States
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Northern General Hospital
🇬🇧Sheffield, United Kingdom