Active not recruitingNAINTERVENTIONAL

F15 Recharge Free Axonics SNM System Clinical Study

This study is for adults experiencing problems with bladder control, such as leaking urine (urinary urge incontinence) or needing to go to the toilet very often (urinary frequency). It's also for those with bowel control problems (fecal incontinence). It's testing a new version of a device called the Axonics sacral neuromodulation (SNM) system. This system is a small implant that helps to regulate the nerves that control your bladder and bowels. The main difference with this new device is that it doesn't need to be recharged. The study aims to understand how safe and effective this implanted device is for people who haven't found relief with other usual treatments. It's an important step to ensure medical devices meet new safety standards.

At a glance

Status

Active not recruiting

Phase

Sponsor

Axonics, Inc.

Enrolment target

144

Start

08 Dec 2023

Estimated completion

01 Dec 2027

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

What is this study about?

This study is carefully looking at a new medical device designed to help people who have trouble controlling their bladder or bowels. These conditions, like suddenly needing to go to the toilet urgently, leaking urine, going to the toilet very often, or having trouble controlling bowel movements, can really affect daily life.

The device being tested is called the Axonics recharge-free sacral neuromodulation (SNM) system. Think of it as a small, smart implant that sends gentle electrical pulses to the nerves that control your bladder and bowels. These nerves can sometimes not work as well as they should, leading to these control problems. The unique thing about this version of the device is that, once implanted, it doesn't need to be recharged, which can be very convenient for patients.

The main goal of this study is to check how well this device works and if it's safe for people to use. It's part of an ongoing process to make sure all medical devices meet the highest safety and performance standards, especially with new regulations coming into effect. This research is important because it could offer another option for people who haven't found relief with other common treatments for their bladder or bowel control issues.

Key takeaways

Tests a new, non-rechargeable device for bladder and bowel control.
Aimed at adults where other treatments haven't worked.
Focuses on safety and effectiveness.
Involves a small implant procedure and follow-up appointments.
Voluntary participation with the right to withdraw.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must also have trouble with bladder control (leaking urine or needing to go very often) or bowel control (fecal incontinence). Importantly, you should have tried other standard treatments for these conditions that haven't worked well for you, or your doctor feels these treatments aren't suitable for you.

There are also some reasons why you might not be able to join. For example, if you have a serious medical condition that could interfere with the device or the study results, you might not be eligible. This includes certain brain or nerve conditions like multiple sclerosis. Also, if you've previously tried a similar nerve stimulation treatment and it didn't help you, this study might not be suitable.

Other reasons for not being able to join include having certain psychological conditions that might make it hard to follow the study's requirements, or if you're allergic to materials used in the device (like titanium). If you are a woman who is breastfeeding or pregnant, you also wouldn't be able to take part in this study.

Quick self-check

Are you 18 years or older?
Do you have problems with bladder or bowel control that haven't improved with other treatments?
Are you willing and able to attend all clinic visits for up to one year?
Are you able to understand and sign consent forms?
Are you *not* pregnant or breastfeeding (if female)?
Have you *not* had a similar nerve stimulation device that didn't work for you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a full discussion with the study team to understand everything involved and give your written consent. Once enrolled, the study involves having the small Axonics device implanted. You would then attend several follow-up appointments at the clinic for up to one year after the device is put in. These appointments are important for the medical team to check how you are doing, how the device is working, and to assess any changes in your bladder or bowel control. The exact number and timing of visits would be explained in detail by the study team, but generally, they involve regular check-ups to monitor your progress.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the device might help improve your bladder or bowel control, offering relief where other treatments have not. However, there's no guarantee the device will work for everyone, and like any medical procedure, there are potential risks associated with the implant surgery, such as infection or pain. The study team will explain all known risks and discomforts to you fully. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Hartford Healthcare
Waterford, United States
Florida Gulf Clinical Research
Bradenton, United States
East Coast Institute of Research
Jacksonville, United States
Florida Bladder Institute
Naples, United States
Atrium Health
Macon, United States
Minnesota Urology
Coon Rapids, United States
Adult Pediatric Urology & Urogynecology
Omaha, United States
Columbia University Medical Center
New York, United States
The Oregon Clinic
Portland, United States
Southern Shores Urogynecology
Myrtle Beach, United States
Houston Colon
Houston, United States
Erasmus Medical Center
Rotterdam, Netherlands

+4 more sites — see the official record for the full list.

Common questions

What is sacral neuromodulation (SNM)?

SNM is a treatment that uses gentle electrical pulses to stimulate nerves near your tailbone (sacrum) that help control bladder and bowel function.

What does 'recharge-free' mean for this device?

It means that once the device is implanted, you don't need to regularly charge it with an external charger, making it very convenient.

Will I feel the electricity from the device?

The stimulation is usually set to be a comfortable sensation, not painful. Your doctor will adjust it to what feels right for you.

How long does the study last?

If you join the study, you'll be followed up for up to one year after the device is implanted.

Can I still take my regular medicines if I join?

You will discuss all your current medications with the study team, and they will advise if any changes are needed during the study.