F15 Recharge Free Axonics SNM System Clinical Study

NCT06186765 | Active Not Recruiting FDA Device

• 1 other identifier: 105-0108
• Study Type: interventional
• Target: 144
• Locations: 3 countries
• Sites: 16

Brief Summary

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.

Conditions

Fecal Incontinence (FI); Urinary Urge Incontinence (UUI); Urinary Frequency (UF)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Adverse event reporting (Safety)

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

  3 months

Secondary Outcomes (4)

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

  1 year

• Performance/Effectiveness - Improvement in Fecal Incontinence Survey

  1 year

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

  3 months, 6 months, 1 year

• Adverse event reporting (Safety)

  1 year

Study Arms (1)

Single Arm - product does not have Communauté Européenne (CE) Mark in Europe

OTHER

Observational

Device: Axonics SNM System (Model 4101)

Interventions

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).

Single Arm - product does not have Communauté Européenne (CE) Mark in Europe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Axonics, Inc.: lead

Study Sites (16)

Hartford Healthcare

Waterford, Connecticut, 06385, United States

Location

Florida Gulf Clinical Research

Bradenton, Florida, 34205, United States

Location

East Coast Institute of Research

Jacksonville, Florida, 32216, United States

Location

Florida Bladder Institute

Naples, Florida, 34109, United States

Location

Atrium Health

Macon, Georgia, 31201, United States

Location

Minnesota Urology

Coon Rapids, Minnesota, 55433, United States

Location

Adult Pediatric Urology & Urogynecology

Omaha, Nebraska, 68114, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The Oregon Clinic

Portland, Oregon, 97225, United States

Location

Southern Shores Urogynecology

Myrtle Beach, South Carolina, 29572, United States

Location

Houston Colon

Houston, Texas, 77030, United States

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Bristol Urological Institute

Bristol, BS105NB, United Kingdom

Location

University College London Hospital

London, W1G 8PH, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Fecal Incontinence

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Prof. Bertil Blok, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Gita Ghadimi, OD

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 2, 2024
• Study Start: December 8, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); NL (1); US (11)