F15 Recharge Free Axonics SNM System Clinical Study

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

F15 Recharge Free Axonics SNM System Clinical Study

Condition
Urinary Urge Incontinence (UUI)
Intervention / Treatment

-

Contacts and Locations

Bradenton

Manatee Medical Research Institute, Bradenton, Florida, United States, 34205

Jacksonville

East Coast Institute of Research, Jacksonville, Florida, United States, 32216

Naples

Florida Bladder Institute, Naples, Florida, United States, 34109

Macon

Atrium Health, Macon, Georgia, United States, 31201

Coon Rapids

Minnesota Urology, Coon Rapids, Minnesota, United States, 55433

Omaha

Adult Pediatric Urology & Urogynecology, Omaha, Nebraska, United States, 68114

Portland

The Oregon Clinic, Portland, Oregon, United States, 97225

Houston

Houston Colon, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Axonics, Inc.,

Prof. Bertil Blok, MD, PhD, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center

Study Record Dates

2026-06