R20 Sacral Neuromodulation for Fecal Incontinence: Post‑Market Follow‑Up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multi-center, prospective, open-label registry of the Axonics SNM System Model 5101 (R20). It follows patients who receive the rechargeable R20 device to monitor safety and performance in real-world use. Eligible participants are adults with fecal incontinence who meet the device’s indications and consent to the evaluations at participating clinical centers. Data collected will describe device operation, adverse events, and outcomes related to continence and quality of life. The study is observational and does not include a randomized comparison to other therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years or older
2. Primary indication of Fecal Incontinence (FI)
3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers

Exclusion Criteria:

1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements
3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test

Where it's running

• The Christ Hospital
  Cincinnati, Ohio, United States Recruiting
• Female Urology of Nashville Research Partnership
  Nashville, Tennessee, United States Recruiting
• Houston Colon
  Houston, Texas, United States Recruiting
• Northern General Hospital
  Sheffield, United Kingdom Recruiting
• Columbia University Medical Center
  New York, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Keith Chapple, MD — Sheffield Teaching Hospitals NHS Foundation Trust
• Study coordinator: Caroline Beaudoint
• Email: caroline.beaudoint@bsci.com
• Phone: +32 (0) 479 90.41.63

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.