Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
University of Chicago
Chicago, Illinois, United States
RECRUITINGBradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
RECRUITINGPinderfields Hospital
Wakefield, West Yorkshire, United Kingdom
RECRUITINGPerformance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify 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
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame: 3 months
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify 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: 12 months
Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence. Assessed if participant had a score of ≥6 at baseline.
Time frame: 12 months
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University College London Hospital
London, United Kingdom
RECRUITING