RecruitingOBSERVATIONAL

Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

This study is looking at a small, rechargeable device called Axonics R20, which is already available to help people who have problems with bowel leakage, also known as faecal incontinence. The main goal is to keep checking that the device is safe and works well for people using it in their daily lives. This is a follow-up study, meaning the device has already been approved for use, and researchers want to gather more information on how it performs over time in a real-world setting. If you're an adult over 18 with bowel leakage and your doctor thinks this device might help you, you could be eligible to take part in this study.

At a glance

Status

Recruiting

Sponsor

Axonics, Inc.

Enrolment target

Start

02 Jul 2026

Estimated completion

01 Jun 2028

Fecal Incontinence

What is this study about?

This study is about a medical device called Axonics R20. It's a small, rechargeable device that is designed to help people who experience bowel leakage, which is medically known as faecal incontinence. This condition means you have trouble controlling when you pass stools, which can be very difficult and upsetting to live with.

The Axonics R20 device is a type of 'neuromodulation' system. This means it works by sending gentle electrical signals to the nerves that control your bowel function. The aim is to help these nerves work better, giving you more control over your bowels and reducing leakage episodes. The device is already approved for use, and this study is a 'post-market clinical follow-up'. This simply means that researchers are continuing to watch how well it works and how safe it is for people using it in everyday situations, rather than during the initial testing phase.

Taking part would help gather important information about the device's long-term safety and how effective it is for patients like you. This information helps doctors and device manufacturers ensure that treatments continue to be the best they can be and that patients receive the most appropriate care for their condition.

Key takeaways

This study is for people in the UK with bowel leakage (faecal incontinence).
It checks the long-term safety and effectiveness of an existing device called Axonics R20.
The Axonics R20 is a small, rechargeable device designed to improve bowel control.
Participation means having the device implanted and attending follow-up appointments.
You must be 18 or older and not have certain other health conditions.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be 18 years old or older and have a main diagnosis of bowel leakage (faecal incontinence). You also need to be willing to understand and sign a consent form, which explains everything about the study, and agree to attend all the planned appointments at the study clinic.

There are some reasons why you might not be able to join. For example, if you have other serious health problems that could make it difficult to follow the study rules or affect how the device works. This includes certain brain or nerve conditions like multiple sclerosis. Also, if you have severe mental health conditions that might make it hard to understand or keep up with the study requirements, you might not be eligible.

You also can't take part if you're allergic to materials like titanium or silicone, which are used in the device. If you are a woman, you cannot be pregnant or breastfeeding to join this study. The study doctors will carefully check all these points to make sure the study is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a main diagnosis of bowel leakage (faecal incontinence)?
Are you able to understand and sign a consent form?
Are you willing to attend all study appointments?
Are you not pregnant or breastfeeding (if you are a woman)?
Do you not have any known allergies to materials like titanium or silicone?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Axonics R20 device as part of your treatment for bowel leakage. You will have regular visits to the clinic so the doctors can check how you are doing, how the device is working, and if you are experiencing any side effects. You won't need to take any specific study medication, as the focus is on the device itself. These visits will involve standard checks related to your bowel condition and device function. The total length of your participation will involve follow-up appointments over a period of time, ensuring ongoing checks of the device's safety and performance.

Potential risks and benefits

Taking part in this study could offer the potential benefit of improving your bowel control and quality of life through the use of the Axonics R20 device, which is already approved for use. However, like any medical treatment involving a device, there are potential risks, such as discomfort, infection, or issues with the device itself. The study doctors will explain all known risks to you in detail. You are always free to change your mind and leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

Common questions

What is 'bowel leakage'?

Bowel leakage, or faecal incontinence, means you have trouble controlling your bowel movements, leading to accidental leaks of stool.

What is the Axonics R20 device?

It's a small, rechargeable device that sends gentle electrical signals to nerves to help improve bladder and bowel control.

Is this a new, untested device?

No, the Axonics R20 device is already approved and available. This study is just checking how well it works for patients over time.

Will I have to pay to be in the study?

No, clinical trials usually cover the costs of study-related treatments and appointments, but you should always check with the study team.

What if I change my mind after joining?

You can leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Caroline Beaudoint

caroline.beaudoint@bsci.com +32 (0) 479 90.41.63 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.