Axonics SNM System for Overactive Bladder and Fecal Incontinence

Recruiting at 13 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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

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 data supports the effectiveness of the Axonics SNM System treatment for overactive bladder and fecal incontinence?

The Axonics SNM System has shown effectiveness in treating urinary urgency incontinence, a condition related to overactive bladder, with positive outcomes reported in studies over one and two years. This system is designed to last at least 15 years, reducing the need for frequent surgeries, and is considered safe and effective for improving bladder function by stimulating the sacral nerves. ^{1 2 3 4 5}

How is the Axonics SNM System treatment different from other treatments for overactive bladder and fecal incontinence?

The Axonics SNM System is unique because it is a rechargeable sacral neuromodulation device designed to last at least 15 years, reducing the need for frequent replacements compared to non-rechargeable systems. It is also the first FDA-approved SNM device that is MRI-safe, making it suitable for patients who require regular MRI scans. ^{1 2 3 4 6}

Research Team

Prof. Bertil Blok, MD, PhD

Principal Investigator

Erasmus Medical Center

Eligibility Criteria

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.

I am 18 years old or older.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence. [2020]

2. United States 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Satisfaction with a rechargeable sacral neuromodulation system-A secondary analysis of the ARTISAN-SNM study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Initial experience using the Axonics sacral neuromodulation system in patients with multiple sclerosis. [2022]