PMCF Study of the Axonics SNM System Model 5101 (R20)

Not Applicable

Not yet recruiting

• Conditions: Urinary Urge Incontinence (UUI); Urinary Frequency (UF); Overactive Bladder (OAB)

• Registration Number: NCT06789406
• Lead Sponsor: Axonics, Inc.

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.

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-12
• Study Start: 2025-09-01
• Primary Completion: 2026-03
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse event reporting (Safety)	3 months	Device related, procedure-related and all serious adverse events
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.