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NCT Number: NCT06789406

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

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.

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Key information

Conditions

Urinary Urge Incontinence (UUI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder (OAB) Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Frequency (UF) Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bradford Royal Infirmary, Bradford, West Yorkshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
  • Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Axonics SNM System INS Model 5101 (R20)

Device

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.

Primary outcomes

  1. Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)

    Time frame: 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.

  2. Adverse event reporting (Safety)

    Time frame: 3 months

    Device related, procedure-related and all serious adverse events

Secondary outcomes

  1. Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)

    Time frame: 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.

  2. Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Beaudoint

CONTACT

[email protected]

+32479904163

Erum Shaikh

CONTACT

[email protected]

657-626-4310

Sponsors and collaborators

Lead sponsor

Axonics, Inc.

Industry

Registry information

Official study title

Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Jan 23, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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