Axonics SNM System for Overactive Bladder and Fecal Incontinence

Recruiting at 15 trial locations

Overseen By Gita Ghadimi, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Axonics, Inc.

Disqualifiers: Neurological conditions, Psychiatric disorders, SNM non-responder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Axonics SNM System (Axonics Sacral Neuromodulation System), to evaluate its effectiveness for individuals with overactive bladder (OAB) or fecal incontinence (FI). The goal is to determine if this system can improve symptoms for those who haven't found success with other treatments. Individuals experiencing constant urges to urinate or difficulty controlling bowel movements, despite past treatments, might find this trial suitable. Participants will need to visit a study site and complete follow-ups for a year. As an unphased trial, this study offers a unique opportunity to explore new solutions for managing OAB and FI symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Axonics SNM System is safe for treating overactive bladder and fecal incontinence?

Research has shown that the Axonics SNM System is a safe treatment for people with overactive bladder and fecal incontinence. In a previous study, 89% of participants experienced significant symptom improvement after using the system for one year. This indicates that the treatment is both effective and well-tolerated by most users.

The Axonics SNM System aids in controlling bladder and bowel functions, and studies have found it to be safe. The available data contains no major reports of negative side effects linked to the system. This information should reassure those considering participation in a trial with this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Axonics SNM System is unique because it uses sacral neuromodulation (SNM) to treat overactive bladder and fecal incontinence. Unlike traditional treatments such as medications or behavioral therapies that primarily aim to manage symptoms, SNM targets the communication between the nerves and the bladder or bowel, potentially addressing the root cause of these conditions. Researchers are excited about this system because it offers a minimally invasive solution that can provide long-term relief and improve quality of life without the side effects often associated with medications.

What evidence suggests that the Axonics SNM System is effective for overactive bladder and fecal incontinence?

Participants in this trial will receive the Axonics SNM System, which has effectively treated overactive bladder (OAB) and fecal incontinence (FI). In the ARTISAN-SNM study, 89% of participants noticed major improvements in urinary symptoms after one year. Another study found that 90% of participants experienced similar benefits in just six months. These findings suggest that the Axonics SNM System can help people regain control over bladder and bowel functions. Additionally, research has shown that the treatment is safe, with positive results in both short-term and long-term studies. ^{1 2 3 6 7}

Who Is on the Research Team?

Prof. Bertil Blok, MD, PhD

Principal Investigator

Erasmus Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with overactive bladder (OAB) or fecal incontinence (FI) who haven't had success with standard treatments. Participants must be able to give informed consent and commit to follow-up assessments for up to a year.

Inclusion Criteria

You are able to sign a consent form and agree to attend all required check-ups and evaluations for up to 1 year.

I have overactive bladder or fecal incontinence and treatments haven't worked for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Axonics recharge free SNM System for overactive bladder and/or fecal incontinence

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Axonics SNM System

Trial Overview The study is testing the Axonics SNM System, a device designed for people with OAB or FI. It's a single-arm evaluation, meaning all participants receive the same treatment without comparison to another group or placebo.

How Is the Trial Designed?

Group I: Single Arm - product does not have Communauté Européenne (CE) Mark in Europe Experimental Treatment 1 Intervention

Observational

Axonics SNM System is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Axonics SNM System for:

• Urinary retention
• Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
• Chronic fecal incontinence

Approved in Canada as Axonics SNM System for:

• Urinary retention
• Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
• Chronic fecal incontinence

Approved in European Union as Axonics SNM System for:

• Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
• Faecal incontinence

Who Is Running the Clinical Trial?

Axonics, Inc.

Lead Sponsor

Trials

7

Recruited

820+

Published Research Related to This Trial

In a study of 15 multiple sclerosis patients with urge urinary incontinence, implantation of the Axonics System led to significant improvements in urinary symptoms, with average UDI-6 scores dropping from 56.6 to 25.2 (p < 0.0001).

Most patients also reported enhanced quality of life, as indicated by IIQ-7 scores improving from 59.0 to 22.2 (p < 0.001), particularly in areas related to travel, social interactions, and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience using the Axonics sacral neuromodulation system in patients with multiple sclerosis. Chen, A., Kapur, A., Mossack, S., et al.[2022]

In the ARTISAN-SNM study involving 129 patients with urinary urgency incontinence, the Axonics® System demonstrated a high efficacy rate, with 89% of participants achieving a significant reduction in UUI episodes after one year.

The system is safe, with no serious device-related adverse events reported, and all participants were able to recharge their devices, indicating good user satisfaction with the recharging process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence. Benson, K., McCrery, R., Taylor, C., et al.[2020]

In a study of 129 participants with urinary urgency incontinence treated with the Axonics® System, 93% were therapy responders after 2 years, with 82% experiencing a 75% or greater reduction in UUI episodes, and 37% achieving complete dryness.

The Axonics System demonstrated sustained safety and efficacy over the 2-year period, with no serious device-related adverse events reported, and high participant satisfaction regarding the device's recharging process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. Pezzella, A., McCrery, R., Lane, F., et al.[2021]

The Axonics® System is an FDA-approved continuous sacral neuromodulation therapy that has been shown to be a safe and effective treatment for overactive bladder and urge urinary incontinence, providing significant patient satisfaction.

This device features a rechargeable, compact design that is MRI safe and offers a long battery life of approximately 15 years, although patients may face challenges related to the need for regular recharging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence. Wang, A., Rourke, E., Sebesta, E., et al.[2021]

A year after receiving the Axonics sacral neuromodulation (SNM) System, 94.3% of participants reported satisfaction, with 68.5% being 'very satisfied', indicating high efficacy and acceptance of the treatment for urgency urinary incontinence.

Satisfaction was closely linked to symptom improvement; those who were 'very satisfied' experienced significantly greater reductions in daily voids and leaks, suggesting that better treatment outcomes lead to higher patient satisfaction over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with a rechargeable sacral neuromodulation system-A secondary analysis of the ARTISAN-SNM study. Geynisman-Tan, J., Mueller, MG., Kenton, KS.[2021]

Sacral neuromodulation (SNM) is a safe and effective therapy for improving bladder function in patients with overactive bladder (OAB), utilizing electrical stimulation of sacral nerves to enhance communication between the bladder and brain.

The recently introduced Axonics SNM System® offers a rechargeable option that lasts at least 15 years, potentially reducing the need for repeat surgeries and providing cost advantages for healthcare systems, while also giving patients more choices in their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation system for treating refractory overactive bladder. Phillips, A.[2021]

Citations

1. axonics.com axonics.com/hcp/clinical-outcomes/

Axonics® System Clinical Outcomes Backed by the pivotal ARTISAN-SNM trial study and RELAX-OAB study, Axonics® is clinically proven to help people regain urinary and bowel control.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7384085/

One‐year outcomes of the ARTISAN‐SNM study with ... The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06186765

NCT06186765 | F15 Recharge Free Axonics SNM System ... Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal ...

4. axonics.com axonics.com/wp-content/uploads/2023/08/AxonicsArtisan6MmanuscriptPDFLicensed.pdf

6-Month Results of the ARTISAN-SNM Study Conclusions: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724006271

The future of neuromodulation for functional pelvic problems Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Neurourol ...

6. isrctn.com isrctn.com/editorial/retrieveFile/a33c0aac-2874-40aa-9c90-26d8b5d719d2/45523

Safety and Effectiveness of the Recharge-Free Axonics ... effectiveness of the F15 SNM System in patients with urinary urgency incontinence (UUI) and fecal incontinence (FI) who have a minimum of one-year follow-up.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10972000/

Sacral Neuromodulation: Device Improvement and Current ... Sacral neuromodulation (SNM) offers a therapeutic approach to urological patients suffering from idiopathic overactive bladder (OAB) syndrome.