Sacral Neuromodulation for Overactive Bladder

Recruiting at 6 trial locations

Overseen By Gita Ghadimi, OD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Axonics, Inc.

Disqualifiers: Neurological conditions, Uncontrolled diabetes, 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: 6 months

150 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Axonics SNM System treatment for overactive bladder?

The Axonics SNM System has been shown to be a safe and effective treatment for overactive bladder, with studies indicating positive outcomes for patients with urinary urgency incontinence. The system is designed to last for at least 15 years, reducing the need for frequent replacements. ^{1 2 3 4 5}

Is the Axonics Sacral Neuromodulation System safe for humans?

The Axonics Sacral Neuromodulation System is considered safe for treating overactive bladder and urinary urgency incontinence, with studies showing long-term safety and effectiveness. It is a rechargeable device approved by the FDA, designed to last at least 15 years, reducing the need for frequent replacement surgeries. ^{2 3 5 6 7}

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

The Axonics SNM System is unique because it is the first rechargeable sacral neuromodulation device, designed to last at least 15 years, reducing the need for frequent replacement surgeries compared to non-rechargeable systems. ^{2 3 4 6 8}

Research Team

Karen Noblett, MD

Principal Investigator

Axonics, Inc.

Eligibility Criteria

This trial is for men over 18 with an overactive bladder due to conditions like prostate cancer, benign prostatic hyperplasia, or after treatments like prostatectomy. Participants must have urinary urgency incontinence and be willing to attend follow-up assessments for a year.

Inclusion Criteria

I had surgery to reduce prostate size over 6 months ago.

Key

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 SNM System for treatment of overactive bladder

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants continue to be monitored for long-term outcomes and adverse events

1 year

Treatment Details

Interventions

• Axonics SNM System

Trial Overview The Axonics SNM System, a device designed to treat overactive bladder symptoms in men, is being tested. The study will monitor the effectiveness of this system post-market in real-world clinical settings.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Clinical outcomes with use of Axonics SNM system for the male OAB population.

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

Sacral neuromodulation, specifically the rechargeable Axonics device, is a safe and effective treatment option for patients with overactive bladder who do not respond to first- and second-line therapies.

Untreated overactive bladder can significantly impair quality of life, highlighting the importance of effective management options like sacral neuromodulation for those with refractory symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the rechargeable sacral neuromodulation system to treat refractory overactive bladder. Albabtain, M., Chughtai, B., Cho, A., et al.[2021]

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]

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]

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]

The Axonics rechargeable sacral neuromodulation (SNM) system demonstrated long-term efficacy for overactive bladder (OAB), with 90% of subjects still responding to therapy after 2 years and 28% achieving complete dryness.

The study reported no serious device-related adverse events, indicating a strong safety profile, and high satisfaction rates among subjects, with 93% expressing contentment with the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Blok, B., Van Kerrebroeck, P., de Wachter, S., et al.[2020]

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]

Sacral neuromodulation (SNM) is a minimally invasive treatment for overactive bladder (OAB) and other pelvic disorders, using a pacemaker to deliver electrical pulses that help regulate nerve signals from pelvic organs.

The article reviews the effectiveness and safety of SNM for patients with refractory OAB, detailing its mechanism of action, implantation techniques, and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation for refractory overactive bladder]. van Ophoven, A.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Review of the rechargeable sacral neuromodulation system to treat refractory overactive bladder. [2021]

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

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

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

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

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

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

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

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. [2020]

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation for refractory overactive bladder]. [2019]