Sacral Neuromodulation for Overactive Bladder

Recruiting at 13 trial locations

Overseen By Catherine Cabiling

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Axonics SNM System, a sacral neuromodulation therapy, for men with overactive bladder. The focus is on those who have undergone prostate surgery, radiation, or surgery for an enlarged prostate (BPH). Participants should experience symptoms like frequent or urgent urination. Candidates must not have had recent prostate treatments or certain nerve-related conditions. The trial seeks to gather data on the effectiveness of this treatment after its approval for use. As an unphased trial, it offers participants the chance to contribute to understanding the broader benefits of an already approved treatment.

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 prior data suggests that the Axonics SNM System is safe for treating overactive bladder in male patients?

Research has shown that the Axonics SNM System is safe for people. In one study, over 1,100 patients using this system experienced no serious harmful effects related to the device. Another study found that even after two years, patients continued to benefit from the system without major safety issues. These results suggest that the Axonics SNM System is well-tolerated by people with overactive bladder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Axonics Sacral Neuromodulation (SNM) System because it offers a new way to treat overactive bladder symptoms by targeting the sacral nerves directly. Unlike traditional treatments such as medications that often focus on relaxing bladder muscles or lifestyle changes to manage symptoms, the Axonics SNM System uses mild electrical pulses to modulate nerve activity, potentially offering relief for those who haven't found success with other options. This innovative approach promises long-term symptom reduction with a minimally invasive procedure, setting it apart from the typical pharmacological or surgical treatments.

What evidence suggests that the Axonics SNM System is effective for treating overactive bladder?

Research has shown that the Axonics SNM System effectively treats overactive bladder. In the ARTISAN-SNM trial, 89% of participants experienced significant symptom improvements after one year. Other studies found that 90% of users noticed major benefits within six months. The system is already approved for treating overactive bladder, urinary retention, and bowel control issues. The Axonics SNM System sends gentle electrical signals to the nerves controlling the bladder, helping improve control. Participants in this trial will be grouped based on their medical history, such as post-prostatectomy, radiation, or benign prostatic hyperplasia (BPH), to evaluate the system's effectiveness in these specific contexts. ^{1 3 6 7 8}

Who Is on the Research Team?

Gita Ghadimi, OD

Principal Investigator

Boston Scientific Corporation

Are You a Good Fit for This Trial?

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.

I agree to follow the study's procedures and visit the clinic for up to 1 year.

I had radiation therapy for prostate cancer more than 6 months ago.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Radiation Experimental Treatment 1 Intervention

History of radiation for cancer treatment at least 6 months prior to enrollment

Group II: Post-prostatectomy Experimental Treatment 1 Intervention

History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment

Group III: Benign Prostatic Hyperplasia (BPH) Experimental Treatment 1 Intervention

History of cytoreductive BPH surgery at least 6 months prior to enrollment

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

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 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]

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]

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 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]

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 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]

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

SNM has been approved for the treatment of overactive bladder (OAB), non-obstructive urinary retention (NOUR), and faecal incontinence (FI), while PTNS has only ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7217215/

Two‐year safety and efficacy outcomes for the treatment of ...

The Axonics System provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs.

7.

axonics.com

axonics.com/images/files/03-27-2023/110-0197-002_rC_Information_for_Prescribers_and_Patients.pdf

Information for Prescribers and Patients

Safety data were reported in a total of 1,111 patients that had SNM system implants, and effectiveness data were reported in a total of 1,075 implanted patients ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32243625/

Two-year safety and efficacy outcomes for the treatment of ...

The Axonics System provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device-related AEs.