RecruitingNAINTERVENTIONAL

PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

This study is a follow-up assessment of a device called the Axonics SNM System (Model 5101), which is used to treat problems like overactive bladder, frequent urination, and bladder leakage (urinary urgency incontinence). This particular system, known as the R20, has already been approved for use. The main goal of this study is to continue checking its long-term safety and how well it performs in real-world use. Researchers want to make sure it keeps helping patients as expected and that any risks are well understood. It's about gathering more information on people who are already using the device to confirm its benefits over time.

At a glance

Status

Recruiting

Phase

Sponsor

Axonics, Inc.

Enrolment target

Start

18 Sep 2025

Estimated completion

01 Oct 2031

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Overactive Bladder (OAB)

What is this study about?

This research is focused on a medical device called the Axonics SNM System, specifically Model 5101 (also known as R20). This system is designed to help people who experience issues with their bladder, such as needing to go to the toilet very often (urinary frequency), having sudden, strong urges to urinate that are hard to control (overactive bladder), or accidentally leaking urine because they can't make it to the toilet in time (urinary urge incontinence).

This isn't a study to test a brand-new treatment. Instead, it's a 'post-market clinical follow-up.' This means the Axonics SNM System Model 5101 has already been approved for use, and it's now widely available. The purpose of this study is to gather more information on how well it works and how safe it is over a longer period in people's everyday lives. It helps ensure that the device continues to provide the expected benefits and remains safe as more people use it.

By carefully observing patients who have this device, doctors and researchers can confirm its long-term performance and benefit. This ongoing assessment helps healthcare professionals understand the device even better and ensures that patients continue to receive effective and safe treatment for their bladder conditions.

Key takeaways

This study is observing an already-approved bladder control device.
It aims to confirm the device's long-term safety and effectiveness.
It's for people with overactive bladder, frequent urination, or bladder leakage.
Participation involves follow-up appointments to check the device and your symptoms.
You must be 18 years or older and meet specific health criteria.
You have the right to leave the study at any time.

Who may be eligible?

To take part in this study, you must be 18 years old or older. You should have been diagnosed with an overactive bladder, frequent urination, or bladder leakage that has not improved with other treatments, or if those treatments are not suitable for you. You also need to be willing and able to give your informed consent, which means you understand what the study involves and agree to participate. You must also be prepared to attend all required follow-up appointments at the clinical centres.

There are some reasons why you might not be able to join. For example, if you have other serious medical conditions, especially certain nerve conditions like multiple sclerosis, or certain mental health conditions, these might prevent you from participating if they could interfere with how the device works or make it difficult to follow the study requirements. If you've previously tried a similar nerve stimulation treatment for your bladder and it didn't help, or if you had a similar device implanted but didn't get any benefit from it, you wouldn't be eligible.

Additionally, if you have known allergies to certain materials found in the device (like titanium or silicone), or if you are a woman who is breastfeeding or pregnant, you would not be able to take part.

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.

I am 18 years old or older.
I have been diagnosed with overactive bladder, frequent urination, or bladder leakage that hasn't responded to other treatments.
I have not had a similar nerve stimulation treatment that failed to provide benefit.
I am not pregnant or breastfeeding (for women).
I do not have certain serious medical conditions or allergies to device materials that might exclude me.
I am willing to attend follow-up appointments and provide informed consent.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be part of a group of people whose progress with the Axonics SNM System will be carefully monitored. This study is designed to assess the device's ongoing performance, not to test new medications. You will need to attend scheduled appointments at the clinical centre for various assessments. These visits will involve checks to see how the device is working and how your bladder symptoms are responding. The total duration of your participation will depend on the study design and your individual follow-up schedule, which will be explained in full detail before you agree to join.

Potential risks and benefits

The potential benefit of participating is contributing to a better understanding of a treatment already available for overactive bladder, which may ultimately help improve care for others. You would be receiving a treatment that is already approved. Like all medical procedures and devices, there are potential risks, which will be fully explained by the medical team. These could include risks associated with the device implantation or potential side effects, which will be detailed in the consent form. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Chicago
Verified postcode
Chicago, United States· Recruiting
University of Missouri
Verified postcode
Columbia, United States· Recruiting
Bradford Royal Infirmary
Verified postcode
Bradford, United Kingdom· Recruiting
Pinderfields Hospital
Verified postcode
Wakefield, United Kingdom· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the Axonics SNM System?

It's a small device implanted under the skin that sends gentle electrical pulses to nerves controlling the bladder, helping to improve bladder function and reduce symptoms like frequent urination or leakage.

Is this a new treatment being tested?

No, this study is a 'post-market' follow-up. The Axonics SNM System has already been approved for use. This study is checking its long-term safety and effectiveness in people already using it.

What kind of bladder problems does this study look at?

It focuses on overactive bladder, which includes symptoms like needing to urinate often (urinary frequency) and having sudden, uncontrollable urges to urinate that can lead to leakage (urinary urgency incontinence).

Will I have to take new medications?

No, this study is about the device itself, not new medications. Your current medication plan will be discussed with the study team.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Anna Selverian

anna.selverian@bsci.com 714-262-1787 Official trial record

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