THERAPY OVERVIEW Percutaneous Tibial Neuromodulation (PTNM)

Office-based Treatment for Overactive Bladder

The Medtronic NURO™ system delivers electrical pulses through a needle to stimulate the afferent fibers of the tibial nerve that runs posterior to the medial malleolus and extends to the sacral nerve plexus. This treatment, called Percutaneous Tibial Neuromodulation (PTNM) or Percutaneous Tibial Neurostimulation (PTNS), can restore* bladder function and quality of life for your OAB patients — without the side effects of medications or potential self-catheterization.1,2


NURO PTNM Procedure Animation

Animation of percutaneous tibial neuromodulation (PTNM) procedure using the NURO system.
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PTNM Procedure with the NURO System

PTNM involves placing the needle electrode into the lower, inner aspect of either leg, slightly cephalad to the medial malleolus. A ground pad is snapped to a fitting on the underside of the NURO device, and then adhered to a clean, smooth area of skin within reach of the needle insertion site. Typical areas of application include the instep of the foot or the medical aspect of the calcaneus on the same leg as the needle insertion.

The NURO device produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. Among other functions, the sacral nerve plexus regulates bladder and pelvic floor function.


PTNM Treatment duration and sequence

The patient is typically treated once per week for 30 minutes for a period of 12 weeks. No decision regarding therapy effectiveness should be made until the patient completes the 12 therapy sessions. Improvement tends to increase over time throughout the 12 weeks of therapy. Finishing all 12 weeks gives your patients the best opportunity to see the results they want.3

For patients responding to treatment, the time between therapy sessions may be slowly increased after the initial 12 therapy sessions, with the patient closely monitored for the return of symptoms. If symptoms reappear or increase in severity, the patient’s treatment schedule should revert to the last previously effective treatment schedule.


How to administer a PTNM session: step by step

Before you begin, make sure the NURO device is charged. (Device will not deliver a session without sufficient battery power.) Ensure at least one therapy session kit is available.

Nuro Therapy Overview Step 1

Firmly insert device cable to needle holder.

Nuro Therapy Overview Step 3

Remove ground pad and attach to a clean, smooth area of skin within reach of the needle insertion site.

Nuro Therapy Overview Step 5

Insert needle at 60-degree angle. Gently tap needle to pierce skin. Remove guide tube. Advance approximately 2cm using rotating motion.

Nuro Therapy Overview Step 7

Hold power button to turn on device. Press the power button again to get to the Stimulation Level Adjust Mode. Increase stimulation level and observe for patient response. Stimulation setting may be reduced by one level for patient comfort and then press “Start” to begin session.

Nuro Therapy Overview Step 2

Snap ground pad to back of NURO device.

Nuro Therapy Overview Step 4

Clean skin with alcohol pad. Locate needle insertion site on inner portion of lower leg.

Nuro Therapy Overview Step 6

Connect J hook of needle holder to needle.

Nuro Therapy Overview Step 8

If stimulation level needs to be modified during the therapy session, increase or decrease the stimulation level by using the + and - buttons located on the side of the device. Once 30 minutes have elapsed, Therapy Mode will automatically end. Remove needle. Unsnap and remove ground pad. Turn off device.


*

Restored bladder function is defined as a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment.

The most common side effects are temporary and include mild pain or skin inflammation at or near the stimulation site.

While the NURO device was not used in the studies cited here, since it delivers equivalent stimulation therapy as the device used in the studies, a user can expect similar performance.


1

Peters, K. M., S. A. Macdiarmid, et al. (2009). "Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial." J Urol 182(3): 1055-1061.

2

Kobashi K, Margolis E, Sand P, et al. Prospective Study to Evaluate Quality of Life with Percutaneous Tibial Neuromodulation in Drug-Naïve Patients with Overactive Bladder Syndrome. Presented at the 2018 Annual Meeting of the International Continence Society.

3

Kobashi K, Khandwala S, MacDiarmid S, et al. A Prospective Study to Evaluate Efficacy with the NURO Percutaneous Tibial Neuromodulation System in Drug Naïve Patients with overactive bladder syndrome (OAB). Presented at the American Urological Association 2018 Annual Meeting. Journal of Urology. 2018;199(4) Supplement, Page e987.