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Neuromodulation

While neuromodulation (aka Interstim) is NOT approved for the treatment of interstitial cystitis, it is approved for the treatment of incontinence, frequency and urgency. It is being aggressively marketed around the world despite the lack of published studies that verify its LONG TERM effectiveness.

It's very easy for patients to get excited about this procedure as "the" long awaited answer to their symptoms. It's VERY important that you take time to thoroughly research this before agreeing to have the procedure done. In our support forum, you'll find patients on this web site who have had disappointing and, in some cases, terrible experiences with the procedure. You will also find patients who have found great results... usually in reducing their frequency.

You HAVE to do the work to learn about this procedure and how it works, to ask tough questions about successes and failures, and to review the experience level of your doctor. We urge caution when approaching this, the most controversial treatment approach, for IC.

How does neuromodation work in the bladder?

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 fairly new treatment option. Patients with urinary and/or fecal incontinence have also had positive results.

Many doctors around the country, as well as the US FDA, are very clear in stating that this treatment should ONLY be considered after all other conventional therapies have been tried and failed. Why? Because other, less risky and life changing 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. 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. You can talk with patients who have had both good and bad experiences here in our message boards

Go the National Library of Medicine and do a search for any new research studies available that talk about the overall success rates of the procedure. Unfortunately, we've found very few studies. You can find a direct link there at: http://www.ic-network.com/library/

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:

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 for neuromodulation

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

Medtronic has also reported a serious complication with diathermy. Because diathermy uses heat, it has been shown to heat the electrodes found in various medical devices to the point of causing tissue death. Under no circumstance should an medical device patient use any diathermy procedure. Please review the company website for any additional warnings.

A review of the FDA Manufacturer and User Device Experience (MAUDE) database currently reports 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. Take a moment and scan through those MAUDE database records. You can do a search based upon the company and product name.

Conclusion

Neuromodulation 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. And remember, if you're still drinking coffees, teas or sodas (i.e. irritating your bladder on a daily basis), there's a chance that no therapy will be as effective as it could be.

 

Checklist of questions to discuss with your doctor

1. Have you considered and tried other conservative treatments (not necessarily in this order):

2. Have you watched the InterStim patient video? (Available from Medtronic) Do you understand what the difference is between a trial and the surgical implant?

Interstim is a life changing procedure that requires long term maintenance and care. In addition to the initial trial and implant, it may also require multiple programmings, revision surgeries and/or battery replacement. Given the cost and time and it takes to maintain, it's very important that you understand exactly what the procedures are, how the device should be maintained and what future needs, if any, you will have.

2007 Consumer Alert - Please note that in some states (i.e. Floria) medicaid patients may not be able to find physicians who can maintain their device. Please ask your doctor if they will continue to treat you if you lose your insurance or change your health insurance. If they will not continue to provide care for you, please ask if other physicians in your area will. If they won't, this is a good argument for not having the procedure done.

3. Have you talked with other patients who have experience with InterStim (both successes and failures)?

While company videos tend to be extremely encouraging, patients have had a wide variety of experiences with Interstim from glowing successes to agonizing failures. It's important that you talk with others about their experience with the device. The ICN Support Forum is a good way to meet others who are undergoing trials or surgeries. Their experience may be very helpful to you.

4. Have you discussed any concerns with your physician?

Make a list of questions before your final appointment and review them with your physician. Don't be silent.

5. Have you discussed pain care both during and after the trial?

Do you know how to treat any pain you may experience? If so, what will you do or use? Make a list and keep it handy. Keep copies of any prescriptions with you and have them filled before you leave the facility.

6. Are you aware of what you should and should not do during the 3-5 day test stimulation period? (See Patient Guide to Test Stimulation)

7. Have you agreed a “safe word” with your physician to have the test stimulation procedure stopped if the pain is no longer bearable?

8. Do you know how to operate the test stimulator?

9. Do you know how to complete your voiding diaries?

Don't forget to fill them in before and during test stimulation! These will help you determine if the implant is working.

10. Has your physician discussed the complications that can occur with this therapy?

This procedure is certainly not risk free. A review of the MAUDE database at the FDA reveals hundreds of severe complications to implant surgery including deep infections, movement of leads, difficultly walking, shocking sensations and, in one case, apparently a death occurred. Ask your physician what types of complications they've seen?? How they are treated and so forth.

11. Has your physician discussed the long term care required for this therapy??

What is his or her experience with Interstim over the long term? How many programmings are required on average each year?? How many revision surgeries?? Ask for the projected cost over, say, a five year period. Is it affordable for you?

12. If your doctor becomes incapacitated, is there another physician in your area who can provide care for your device?

If a physician relocates, is terminated or simply retires, it's important that you know that there are other medical care providers in your city that can and will provide support for your implant. If there are no other physicians qualified to maintain your device, this may be a reason to consider other therapies first.

13. Ask your physician if they will continue to provide care for your implant if you lose your health insurance or take a different health insurance plan (i.e. Medicaid)

This issue came up in Fall 2007 when a patient relocated to Florida, was placed on Medicaid, and was unable to find a physician who would provide ANY care for her Interstim. Why?? Medicaid was not reimbursing doctors in a timely manner. This is worth asking about, particularly for future procedures that may also be required, such as device removal.