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 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. Below, you'll have the chance to read some of the serious adverse event reports filed with the FDA. On our site, also you'll find patients on this web site who have had terrible experiences. On the otherhand, 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 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.
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 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.
Medtronic - http://www.medtronic.com
ANS - http://www.ans-medical.com
Urosurge - http://www.urosurge.com
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
While some patients have experienced improvement in frequency and/or urgency, others have reported serious and unexpected complications, including:
Medtronic has reported a serious complication with diathermy.
http://www.medtronic.com/neuro/inter...m_warning.html
Also, a review of the FDA Manufacturer and User Device Experience (MAUDE) database (http://www.fda.gov/cdrh/maude.html) 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.
Take a moment and scan through those MAUDE database records. You can do a search based upon the company and product name.
http://www.fda.gov/cdrh/maude.html
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. 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.
Recommended Reading
Nerve Stimulation Check List & Orientation
http://www.ic-network.com/handbook/i...questions.html
Interstim Information website
http://www.interstim.com
Please review safety information, particularly that related to the use of diathermy
Medtronic's List of Risks & Contraindications
http://www.medtronic.com/neuro/inter...m_warning.html
FDA's Manufacturer and User Device Experience (MAUDE)
http://www.fda.gov/cdrh/maude.html
You can research adverse event reports filed with the FDA about this, and any other, medical device.
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. Below, you'll have the chance to read some of the serious adverse event reports filed with the FDA. On our site, also you'll find patients on this web site who have had terrible experiences. On the otherhand, 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 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.
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 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.
Medtronic - http://www.medtronic.com
ANS - http://www.ans-medical.com
Urosurge - http://www.urosurge.com
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:
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?
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:
pain at the implant sites
lead migration resulting in device failure and requiring additional revision surgeries
electrical shocks
uncomfortable sensations in the legs
infection or skin irritation
mechanical device failure
negative change in bowel or urinary habits
numbness
nerve injury
lead migration resulting in device failure and requiring additional revision surgeries
electrical shocks
uncomfortable sensations in the legs
infection or skin irritation
mechanical device failure
negative change in bowel or urinary habits
numbness
nerve injury
Medtronic has reported a serious complication with diathermy.
http://www.medtronic.com/neuro/inter...m_warning.html
Also, a review of the FDA Manufacturer and User Device Experience (MAUDE) database (http://www.fda.gov/cdrh/maude.html) 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.
Take a moment and scan through those MAUDE database records. You can do a search based upon the company and product name.
http://www.fda.gov/cdrh/maude.html
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. 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.
Recommended Reading
Nerve Stimulation Check List & Orientation
http://www.ic-network.com/handbook/i...questions.html
Interstim Information website
http://www.interstim.com
Please review safety information, particularly that related to the use of diathermy
Medtronic's List of Risks & Contraindications
http://www.medtronic.com/neuro/inter...m_warning.html
FDA's Manufacturer and User Device Experience (MAUDE)
http://www.fda.gov/cdrh/maude.html
You can research adverse event reports filed with the FDA about this, and any other, medical device.
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