Neuromodulation for IC/BPS

The 2022 AUA Guidelines for the diagnosis and treatment of IC/BPS state that neuromodulation may be considered as a treatment for IC/BPS if other therapies have not provided adequate symptom relief.(1,2) It may be effective for reducing urinary frequency and urgency but is much less effective for the treatment of pain.

What is neuromodulation?

Neuromodulation uses a mild electrical impulse on various nerves to help maintain nerve function. Two different forms of neuromodulation are available, Urgent PC® (Uroplasty) and Interstim® (Medtronic). Both devices are approved for urinary frequency, urgency, incontinence and overactive bladder. Neither is approved for interstitial cystitis however they are frequently suggested for symptom management, hence their inclusion in the AUA Guidelines.

Post Tibial Nerve Stimulation

Marshall Stoller MD

Dr. Marshall Stoller, UCSF

In general, patients start with the least invasive form of neuromodulation known as post tibial nerve stimulation (PTNS). Invented by Dr. Marshall Stoller (UCSF) in the early 1990’s, it uses an acupuncture needle inserted carefully at the SP6 point above the ankle bone. A nerve stimulation device (aka TENS unit) is then attached to the needle where it delivers a mild, electronic pulse to the nerve. The original protocol required that it be done for just 30 minutes, one day per week for up to ten weeks. When Dr. Stoller’s device lost funding, Uroplasty (now Cogentix Medical) stepped forward with a similar device (Urgent PC) which is now available throughout the USA. Uroplasty offers a Find A Provider Service on their website.

The AUA Guidelines are lukewarm with respect to PTNS results, stating that the research shows minimal success. Yet, it had sufficient research to be approved for coverage by Medicare. In 2022, a new study from Stanford University was released during the AUA 2022 Annual meeting which found that urinary urgency improved the most, with 39% improvement, followed by frequency at 33%. Pain improved by 21%. (3)

Post tibial nerve stimulation offers several benefits:

  • No surgery is required.
  • Risk of adverse event is minimal with only two adverse events filed with the US FDA MAUDE database
  • The cost of Urgent PC is substantially less than the cost of a surgically implanted device.
  • If found ineffective, treatment can be terminated without requiring an additional surgery to remove the device.

Sacral or Pudendal Nerve Stimulation

If post tibial nerve stimulation is ineffective, a more aggressive, surgical approach can be considered. Known as Interstim®, many physicians around the country have been trained to do this procedure. It requires an initial trial procedure inwhich a lead is surgically implanted on either the sacral or pudendal nerve. A wire then extends through the skin where it is attached to a portable nerve stimulation device. For the following two weeks, patients keep a pain and voiding diary. If their symptoms improve during the trial, a permanent surgical implantation is then performed with the stimulator implanted near the hip or upper buttock.

This procedure requires careful consideration. We strongly urge patients to talk with other patients who have gone through this procedure. You’ll find many diverse opinions. Some love it and others regret having it done. You can find four discussion boards dedicated to neuromodulation in the ICN Support Forum where you will find plenty of discussions, both pro and con. Many of of the concerns raised include:

  • Requires multiple, costly surgeries: (1) the trial, (2) the implant, (3) replacement of the batteries and (4) eventual removal of the device at the end of its life cycle.
  • Many serious adverse events have been filed with the US FDA MAUDE database, including MRSA infection, shocking, movement of the device, heart palpitations, changes in heart rhythm and fatalities.
  • The long-term cost of multiple surgeries can be quite high, particularly if revision surgeries must be performed.
  • Requires frequent visits to the urologist for maintenance and monitoring.
  • Some patients who have lost their health insurance have found that their physicians suddenly dropped their care. They report that finding a physician to maintain their device far more difficult without health insurance.
  • Patients with implants are not allowed to have specific medical procedures, such as full body MRI, shortwave diathermy, microwave diathermy and therapeutic ultrasound diathermy treatments. If the patient is in a serious accident, for example, full body MRI cannot be performed without serious risk to the patient and the device.
  • If the device is found to be ineffective, the removal of leads can be challenging. Some doctors have chosen to clip the leads, leaving metal parts in the body, thus providing long-term concerns with using MRI, etc.

Questions to ask your physician about Interstim®

Finding an EXPERIENCED urologist who can perform this surgical procedure is vital. As you discuss this with them, we suggest that you ask the following questions.

  • How many implantation procedures have you done?
  • What training have you received for the care and maintenance of this device?
  • What complications have you experienced in patients during both trial and implant procedures?
  • Were those complications all resolved?
  • How often have your InterStim® patients required additional revision surgeries?
  • How often have your InterStim® patients required explantation (removal)?
  • When doing an explantation, have you encountered any difficulties in removing either the leads or the unit? If so, how did you resolve these?
  • Have any of your patients experienced side effects which persisted after explantation?
  • Have any of your patients developed infections at the surgery sites?
  • Who will I be working with if my device needs reprogramming?
  • Who will I see for care if you are not available?
  • Who should I contact if my device malfunctions?
  • Will you provide care for me if I lose my health insurance? If not, who would treat me?

Questions about costs & insurance coverage

We encourage patients to verify, in writing, that neuromodulation will be covered by their health insurance before surgery. One patient reported that despite her doctors office assuring her that it was covered, she received a bill for over $75,000 dollars a week later with a threat to garnish her wages. She shared that she would have never agreed to the surgery if she had known that it wasn’t covered.

It’s also important to verify if they will cover device removal. Some insurance companies have refused to pay for device removal unless it is malfunctioning, leaving patients angry and frustrated. In general, the longer the device is in the body, the more difficult it can be to remove. Thus, early removal is preferred.

  • Ask your doctors office staff if Interstim® is covered by your insurance and does it require a written pre-authorization? Get their answer in writing.
  • Call the hospital where the procedure will be performed and ask their billing office if Interstim® is covered by your insurance and does it require written pre-authorization. Get their answer in writing too.
  • Lastly, call your insurance company directly and ask them if Interstim® is covered by their insurance and is written pre-authorization required. ALWAYS get their answer in writing.
  • Ask your insurance company if they will cover revision surgeries and device removal. Again, get their answer in writing!

Meet Other Patients & Learn Their Stories With Neuromodulation

The ICN Support Forum has four message boards dedicated to nerve stimulation, including: “Success Stories,” “Failures,” “Considering It” and “Undergoing Trials.” Feel free to post any questions that you have. It’s a great place to read about sucess stories (and failures) and to reach out to other patients who have also undergone the procedure.

References:

  1. Clemens JQ et al. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome.  J Urol 2022. Jul;208(1):34-42
  2. Osborne J. New IC/BPS Guidelines Released in May 2022. ICN. May 23, 2022
  3. AUA 2022 Poster Session – Efficacy of percutaneous tibial nerve stimulation for IC/BPS related lower urinary tract and pelvic symptoms.

Author: Jill H. Osborne
Revised: 7/6/22