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Active, Not Recruiting

NCT Number: NCT06186765

F15 Recharge Free Axonics SNM System Clinical Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Urinary Urge Incontinence (UUI) Digestive System Diseases Fecal Incontinence Fecal Incontinence (FI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms 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

Erasmus Medical Center, Rotterdam, Netherlands

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About this study

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, INS Model 4101. The product is currently marketed under the name F15.

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 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.

Exclusion criteria

  • 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

Treatment and study plan

Axonics SNM System (Model 4101)

Device

Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

Primary outcomes

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

    Time frame: 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.

  2. Performance/Effectiveness - Improvement in Fecal Incontinence Survey

    Time frame: 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.

  3. Adverse event reporting (Safety)

    Time frame: 3 months

    Device-related, procedure-related and all serious adverse events

Secondary outcomes

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

    Time frame: 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.

  2. Performance/Effectiveness - Improvement in Fecal Incontinence Survey

    Time frame: 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.

  3. Performance/Effectiveness - Improvement in Quality of Life Survey (FI)

    Time frame: 3 months, 6 months, 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.

  4. Adverse event reporting (Safety)

    Time frame: 1 year

    Device-related, procedure-related and all serious adverse events

Sponsors and collaborators

Lead sponsor

Axonics, Inc.

Industry

Registry information

Official study title

Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 2, 2024
Registry last updated
Jul 13, 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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