Axonics Sacral Nerve Stimulation

One of Two Sacral Nerve Stimulator Manufacturers (SNS)
Axonics has two models

The purpose of Sacral Nerve Stimulation (SNS) is for the Treatment of Urinary and Fecal Incontinence. However, it can help reduce pudendal neuralgia pain as well.

Pudendal neuromodulation is not a cure for pelvic pain, incontinence or bowel dysfunction, however; the procedure is successful about 85 percent of the time in achieving at least a 50 percent improvement in symptoms. Some experience an 80 to 90 percent improvement.

Beaumont urologist Kenneth M. Peters and his colleagues at Beaumont's Women's Urology and Pelvic Health Center have performed the procedure on greater than 200 patients – which is more than anyone else in the world. 1

Regarding Pudendal Neuralgia: A small 2022 study's data implied that SNS can have beneficial effects on patients with refractory PN.

Large-scale randomized clinical trials are warranted to evaluate the risk factors for prediction of refractory PN. 2

If you are going to have any medical device implanted, ask HOW MANY the doctor has done for pudendal neuralgia. Regrettably, many will say none, but will still want to do the implant. This is because PN is rare. Get a second opinion. Talk to others with PN to see if this is something you want to do because with will be the case with 95% of doctors

Axonic currently has two devices:
1. The Axonics R20™ System which has a rechargeable with a battery designed to last 15
years or more.

Implant size is just 5cc cubic centimeters.
2. The Axonics F15™ System which has a long life battery that does not require
recharging (15 -20 year battery life).

Implant size is just 10cc cubic centimeters. (InterStim X’s 12.5cc)

Batteries are Permanently Internally Surgincalyl Implanted.

Both devices use the same tined lead.

Axonics Battery Sizes: F15 is 5cc

R20 is 10cc

Axonics Sacral Nerve Stimulators (SNS) are conditional safe MR safe for:

1.5T and 3T full-body MRI scans
1.5T and 3T head coil MRI scans
1.5T and 3T upper and lower extremity MRI scans

It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications.

Is there a Trial Period? 7 Days

FDA labeling for trial leads is only approved for 7 days: Many providers test FI patients using a disposable basic evaluation lead. The FDA-approved manual states: “The lead is a temporary device intended to be implanted for no more than 7 days.” Trialing beyond 7 days would put the patient at risk for infection.
The primary objective of the trial is to achieve a 50% improvement. FDA labeling for Sacral Nerve Stimulation therapy during the trial phase for FI patients does not require a duration of more than 1 week.

Sacral nerve stimulation (SNS) works with a tined lead electrode that is placed through Sacral Plexus S3.

The Procedure

The surgical implant takes about an hour to complete and is done at an outpatient surgery center. Often only local anesthesia is used, though some doctors prefer to use general anesthesia. The device is inserted in the lower back, above the buttocks

Side effects are generally minimal, with some patients reporting mild discomfort or bruising at the implant site. Your doctor will also provide detailed post-procedure care instructions to ensure your healthy recovery and the best possible outcomes.

Medicare, work insurance companies and state Medicaids generally DO cover SNS for IC/Bladder pain and fecal incontinence because clinical studies conclude SNS successfully treats these conditions.

1 https://www.beaumont.org/treatments/pudendal-neuromodulation

2 https://pubmed.ncbi.nlm.nih.gov/35793186/ Sacral Nerve Stimulation in Patients With Refractory Pudendal Neuralgia - PubMed (nih.gov)

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Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

Paid for by volunteer until 501c3 status granted by IRS

Axonics Sacral Nerve Stimulation

​It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications.

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It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications.