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Rev: July 16, 2004
Jill Osborne

Created: Jan. 1995
Bev Laumann

You are here: IC Network > Patient Handbook > Treatments > Nerve Stimulation

TENS & Nerve Stimulation

TENS Stimulation

With TENS, mild electric pulses enter the body for minutes to hours two or more times a day either through wires (in pad form) placed on the lower back or the suprapubic region, between the navel and the pubic hair, or through special devices inserted into the vagina in women or into the rectum in men. Although scientists don't know exactly how it works, it has been suggested that the electric pulses may increase blood flow to the bladder, strengthen pelvic muscles that help control the bladder, and trigger the release of hormones that block pain.

TENS is relatively inexpensive and allows the patient to take an active part in treatment. Within some guidelines, the patient decides when, how long, and at what intensity TENS will be used. TENS has been helpful in relieving pain and decreasing frequency for some IC patients. If TENS is going to help, change usually occurs in 3 to 4 months. There are several manufacturers of TENS units, and the price can vary considerably. All of the units are relatively small and easily concealable under loose clothing.

TENS units are available from a number of suppliers around the country. One reliable source is Rajala Rehabilitation. They sell a number of TENS units, as well as pads and supplies.

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Surgical Electrical Nerve Stimulation Techniques

(Revised July 2004 - Jill Osborne)

This invasive and difficult treatment is a variation of TENS, described previously. Some doctors and medical equipment companies (Medtronic, ANS) advocate surgery to permanently implant electrodes and a unit that emits continuous electrical pulses. While it is NOT approved for the treatment of interstitial cystitis, it is approved for the treatment of frequency and urgency. It is being aggressively marketed around the world despite the lack of published studies that verify its LONG TERM effectiveness.

How does it work? Neuromodulation uses mild electrical stimulation of the sacral nerve. For patients with extreme frequency/urgency and who have failed other therapies, this surgical therapy is a new option. Patients with urinary and/or fecal incontinence have also had positive results. However, the US FDA is very clear in stating that this treatment should ONLY be considered after all other conventional therapies have been tried and failed. Why? Because surgery of any type is risky AND other treatments (oral medications) have consistently and effectively reduced the symptoms in many patients. So, for the IC patient, this means that you should not consider this surgery until you have tried both oral (i.e. Elmiron, Hydroxyzine, Elavil & various alternatives) and intravesical (DMSO, Heparin, etc.) therapies.

What does it involve? Patients are first required to undergo a test stimulation, which is a three to five day trial period of stimulation. If the results are favorable, doctors may then recommend a permanent implant. Trials are usually done in outpatient surgery and the patient is awake during the procedure. While using local anesthetic, the urologist will attempt to insert the device into the proper location. Please note that some patients have reported extreme pain during the trial procedure. We recommend that patients discuss pain care, both during and after this procedure, with their physicians well in advance of having the trial. The use of a "safe" word that will inform physicians that they have reached your pain threshold may be useful.

During the trial, patients will be asked to keep a voiding diary to track their symptoms. If, after that period, your diary indicates that it significantly helped your symptoms, you may be recommended to have the permanent implant.

Knowing the risks - Before diving into a major surgical procedure, we recommend that you educate your self about the specific device. Ask for the introductory materials and video provided by the company which are available at no cost. Review the manufacturers web site. Talk with other patients, both pro and con, to learn what their experiences were after surgery. The ICN Message Boards may be a place where you can talk with patients who have had both good and bad experiences. Read any research studies available that talk about the overall success rates of the procedure.

Verify the experience of your physician - Don't forget, as well, to ask your physician about his experience with this treatment. Surgeons new to the procedure are far less experienced. Here are a few suggested questions:

  • How many implants has he or she done?
  • Who trained the doctor in the procedure? When?
  • What have the patient responses been?
  • What adverse events, if any, has he encountered?
  • Have any of the patients needed revision surgery? If so, how many times have patients (on average) required revision?
  • Have any of the devices required removal?
  • Did he remove the device successfully?
  • Will he be available for consultation after the surgery?
  • Will he be able to program the device, or will he require a representative of the company to do so?
  • How often will that representative be available?
  • How often will you be expected to visit your doctors office?
  • Who will cover for your doctor if you are having a problem and that doctor is not available?
  • What post surgical pain care plans are available?

We ask you to be extremely cautious if any doctor recommends this as a first line therapy for IC or OAB. Sadly, some patients have been advised that this was a first line therapy, only to discover after the fact that there were oral medications that could AND SHOULD have been used first.

Known complications - While some patients have experienced improvement in frequency and/or urgency, others have reported serious and unexpected complications, including:

  1. pain at the implant sites
  2. lead migration resulting in device failure and requiring additional revision surgeries
  3. electrical shocks
  4. uncomfortable sensations in the legs
  5. infection or skin irritation
  6. mechanical device failure
  7. negative change in bowel or urinary habits
  8. numbness
  9. nerve injury

A review of the FDA Manufacturer and User Device Experience (MAUDE) database currently reports more than 50 serious adverse events resulting in injury, hospitalization and/or including malfunction of the device, including: bowel perforations resulting in the lead migrating out of the rectum during bowel movements, jolting, shocks, violent shocks, burning" while going through various security systems at airports or stores. Two experienced severe reactions as a result of diathermy, which should not be performed on patients who have the implant.

Conclusion - This is a serious procedure, not to be taken lightly. It is not approved for IC by the US FDA. It is not approved for the treatment of pain. Patients have reported serious complications requiring hospitalization. We urge you to exhaust other, more conservative, treatment strategies before considering this procedure.

Recommended Reading:

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Non-Surgical Electrical Nerve Stimulation Techniques

A non-surgical and much less stressful form of nerve stimulation is currently being tested by Dr. Marshall Stoller, of the UCSF Medical Center in San Francisco, California. In essence, they stimulate the post-tibial nerve in the lower leg with the expectation that the nerve impulses will extend back through the nerve and into the pelvis. Dr. Stoller's research has clearly demonstrated that nerve stimulation dramatically increases blood flow, and hence healing oxygen, to the pelvis and bladder.

Unfortunately, the company that was originally developing this stimulator has gone out of business. A new company Cystomedix has developed a similiar stimulator that is currently in Europe and going through the FDA approval process in the USA.

Read more about this in Dr. Stoller's ICN Guest Lecture transcript.

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