InterStim™ Medronic SNS

One of Two Sacral Nerve Stimulator Manufacturers (SNS)

The main 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.

New Micro SureScan: At 2.8cm3, the InterStim MRI neurostimulator is the smallest (1,2) Sacral Nerve Stimulation device (SNS) on the market. It is designed to deliver the same effective results as the trusted InterStim II system for people with bladder and bowel control problems.

.

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.

Are the Interstim II and Micro SureScan Sacral Nerve Stimulators (SNS) MR safe?

The InterStim™ Micro system, including the InterStim™ SureScan MRI lead, has CE-mark approved labelling for full-body§ 1.5 and 3 Tesla MRI scans. Refer to the MRI Guidelines for a complete list of conditions and instructions for use (available in the Medtronic Manuals Library).

Proprietary SureScan™ MRI technology expands eligibility and allows patients with either InterStim™ system to get full-body§ MRI scans.

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

Sacral Plexus S3.

The Procedure

The procedure to implant an SNS device can be quickly and safely performed at an outpatient surgery center through a minimally invasive surgery. This can often be done under local anesthesia, though some doctors will prefer to use general anesthesia. The device is inserted in the lower back, above the buttocks. The procedure itself typically takes between 20-30 minutes to complete.

VIDEO of complete imlant procecure from Interstim site:

https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/urology/sacral-neuromodulation/education-training/videos.html

Surgery: If the trial produces positive results, the device is implanted in a patient’s lower back near the sacral nerves.

Post-surgery: After surgery, the doctor will program the device’s electrical signals based on the results from the trial period.

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.

Battery is Permanently Internally Surgically Implanted and must be surgically replaced every 4 to 7 years.

Competitor Axonics sizes: F15 is 5cc

R20 is 10cc

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)

____

Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

Paid for by founder until 501c3 status granted by IRS