F15 Recharge Free Axonics SNM System Clinical Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Urge Incontinence (UUI); Fecal Incontinence (FI); Urinary Frequency (UF)
• Intervention / Treatment: Device: Axonics SNM System (Model 4101)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Bristol, United Kingdom, BS105NB
    • Bristol Urological Institute
  • London, United Kingdom, W1G 8PH
    • University College London Hospital
  • Sheffield, United Kingdom, S5 7AU
    • Northern General Hospital
• United States
  • Connecticut
    • Waterford, Connecticut, United States, 06385
      • Hartford HealthCare
  • Florida
    • Bradenton, Florida, United States, 34205
      • Florida Gulf Clinical Research
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute of Research
    • Naples, Florida, United States, 34109
      • Florida Bladder Institute
  • Georgia
    • Macon, Georgia, United States, 31201
      • Atrium Health
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult Pediatric Urology & Urogynecology
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • The Oregon Clinic
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Southern Shores Urogynecology
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Colon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years or older
2. 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
3. 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:

1. 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)
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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm - product does not have Communauté Européenne (CE) Mark in Europe; Observational	Device: Axonics SNM System (Model 4101); Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)	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.	3 months
Adverse event reporting (Safety)	Device-related, procedure-related and all serious adverse events	3 months
Performance/Effectiveness - Improvement in Fecal Incontinence Survey	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 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)	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.	1 year
Adverse event reporting (Safety)	Device-related, procedure-related and all serious adverse events	1 year
Performance/Effectiveness - Improvement in Fecal Incontinence Survey	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.	1 year
Performance/Effectiveness - Improvement in Quality of Life Survey (FI)	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.	3 months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Axonics, Inc.
• Investigators: Principal Investigator: Prof. Bertil Blok, MD, PhD, Erasmus Medical Center; Study Director: Gita Ghadimi, OD, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fecal Incontinence; Urinary Incontinence, Urge
• Other Study ID Numbers: 105-0108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes