Overactive Bladder (OAB), Urinary Frequency (UF), Urinary Urge Incontinence (UUI)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Axonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment 3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Exclusion criteria
1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis) 2. 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 3. 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) 4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 5. A female who is breastfeeding 6. A female with a positive urine pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB) | 3 months | 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. |
| Adverse event reporting (Safety) | 3 months | Device related, procedure-related and all serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB) | 12 months | 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. |
| Performance/Effectiveness - Improvement in Qualify of Life scoring (FI) | 12 months | 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. |
Countries
United Kingdom, United States
Contacts
CONTACTCaroline Beaudoint
CONTACTErum Shaikh
PRINCIPAL_INVESTIGATORMahreen Pakzad, MD
University College London Hospitals
STUDY_DIRECTORGita Ghadimi, OD
Boston Scientific Corporation
Outcome results
None listed