Interesting snippet about the failure rate of Interstim in long-term users...

[ICLori]

This (I'm sure) doesn't tell the whole story, but the numbers are still (IMO) sobering. I would have expected (or hoped for) better performance from such an invasive, expensive bit of machinery.

Blessings, Lori

During the 1990s, sacral neuromodulation began to develop as a new therapy. The exact mechanism of action is not known, but activation of the spinal interneurons or beta-adrenergic neurons, which inhibit bladder activity, has been postulated. All patients must undergo a test of stimulation of the S3 sacral nerve before they can be offered chronic sacral nerve stimulation with an implanted system. Approximately half of the patients respond favorably to the test. Unfortunately, treatment fails in 20-33% within 1-1.5 years of a permanent implant.58 However, there is durable success in 60% of patients at 5 years.59 Use of chronic sacral nerve stimulation may be associated with surgical morbidity, such as pain at the site of the electrodes or neurostimulator, electrode migration, and implant infections. Hardware problems include broken electrodes, isolation defects, and battery exhaustion.

[ICNJess]

Lori,

Can you link me to where you found that article? When was it published? When was the study made? When the InterStim first became available, there were some horrible results. Now, with physicians who are trained more intensly and who are made to specialize in this surgery, I am sure the rates are somewhat different.

And those scenarios don't always happen. They have to list that as a formality, because it does happen sometimes.

Anyone considering the InterStim should do their research thoroughly, on up-to-date facts and data. The only problem I have had with mine is that weight loss affects the way the unit functions. I would highly advise people who get the stimulator to maintain the same weight, or do your weight loss first.

I figure a revisional surgery & the cost of the stim is a very small price to pay for getting some of my life back. It's not for everyone though, so people, if you are considering this know that it's not for pain, and it's not for everyone!

Health and hugs,
Jess

[ICLori]

No problem, here's the link...it was from a journal published in January 2005 so it's pretty recent, not old.

http://www.hmpcommunications.com/cg/displayArticle.cfm?articleID=article3578

Blessings, Lori

[ICNJess]

Hi Lori,

I went over the study in the link you sent (thanks) and when I got to the bottom I read all the studies this was from, and all of them are from the late 80's to late 90's. The article may have been published recently, but from what I can see, all the information is outdated.

I so wish that the doctors and Medtronics, and 3rd parties would put out there some updated research. The statistics need to be put out there, and I know that they are dragging their feet, which really sucks. We have a right to know. :(

[DebbieB]

Hi Jess,

I agree with you a hundred percent where is the updated visions ??

I know of a lady in Canada that had the first procedure done by my doctor in 1985 and she is doing great with her InterStim Implant..
I really think it has to do with the doctor and knowledge of the procedure to be a success..


Debbie

[codyryonwoodward]

Hello everyone. I just wanted to input my 2 cents, they may not be worth anything or not but anyways here goes:

Yes I agree they need to update there figures and yes the scenarios dont always happen to everyone that has the Interstim. But yes there are failure rates and also sucessful rates and I think both need to be mention. Yes I also agree that you should have a doctor should be very experienced in implanting and more than that I feel he must be just as experienced in follow up care and judging whats normal and what's not. All that was mentioned in the article are things that can happen. And lead migration can occur from anything as simple as a fall to car accidents. Even the slightest lead movement from where it was first put in can make the whole unit not work anymore. Now with that said there are great sucess rates also with helping with urgency and freq. Although most times it does not help with pain, although there are doctors out stating this and not wanting to prescribe any kind of pain therapy after the Interstim has been placed.

No one is wanting to put a bad mark on the Interstim I believe we just wanted all avenues explored before getting this form of treatment. When I got mine it was rather new as far as a form of therapy goes and there was not alot of pros and cons concerning the Interstim. This is not something that can be taken lightly and a person needs to know everything good or bad about the Interstim. Also with the Interstim costing so much money I want people to think about the future what happens if you lose your job and lose insurance what then. What if someting happens and you have no insurance or no doctor to fix it what would you do. Is this something they want to risk?? I spent 8 months walking in those shoes with NO HELP from no one not even the doctor who did it. He got his money and that was all he was conerned with.

Now I am very proud for the people that it has helped, and I am glad it can almost give back there life before IC cause I know it can make a big difference when you almost get rid of the urgency and freq and I know I much of a relief that can be....But then there are those of us who now years after having the Interstim that have problems and we want those considering the Interstim to be fully informed. Knowing before hand what they are getting into good and bad. Thats all.

Saying all of this I hope I have not offended anyone reading this I just wanted to show support my support.

[ICLori]

I just posted that snippet because, at least from my end, doctors push the Interstim like it's the greatest thing since sliced bread for IC and act like there are no failures, no problems afterwards, it just works forever for everyone, no nerve damage, etc.

I don't know if everyone else's urologists or uro-gyns are so gung-ho about Interstim, but mine are. And it's not about making money, for them, because they are Army docs and don't get money for pushing Interstim. They just honestly believe it's a 100% cure for all cases of IC, and once you get it in, you are fixed forever, no problems.

When I asked about the reprogramming that often has to be done, I'm told it's because patients do something different - add back "no-no" foods, stop taking meds that helped them before, etc.

I think there is just massive denial in the medical community about the problems with Interstim, and the failure rates.

This snippet was the first thing I've ever seen or heard of, where it talked about problems like having to go through a revision, etc.

So I put it up because I think that those of us who are getting sunshiney stories about Interstim from our doctors, need to see things like this.

Blessings, Lori

[ICNJess]

I'm not trying to start anything here. :( I just am saying that YES there are failures and YES there are successes, but we have nothing to compare ANYTHING to because there are no updated figures out there :( I think they should be made available, and I think it should happen soon.

For every great success, there is a painful disappointing failure. It's like that with every treatment out there but with implanted devices, the risks are greater. I am hoping that some figures are available this year.

[ICLori]

Dusty - thank you so much for your post. I chose to use a completely new, untested device - the Bion - over the Interstim because of the horror stories I read about Interstim. I was glad to have another choice.

It's really hard when you are faced with either bladder removal or a device like this - hard to know what choice to make. You just make a choice and hope you made the best one and wait to see what happens.

I told my urogyn, who is one of the leading experts in the country on Interstim and the Bion, about stories about people being in wheelchairs because of the Interstim. He said first that he'd never heard of any bad results like that, and secondly it was impossible. So you can see that doctors are not sharing information about this, or else they are seeing it but refusing to tell their patients about it. I don't know which. I'd like to believe my doc was telling the truth when he said he'd never heard of any of this.

I don't know. I get the feeling doctors think that this is a disease that strikes mostly women over the age of 40, and we are just old women anyway and ought to go jump off a cliff, society doesn't want us anymore, so why bother investing any time and energy into helping us when we don't even really have a "right" to live anyway because we are not men, we are not young and cute women...whatever.

All I know is that the doctors I've talked to make it seem as if failure rates are close to zero, this device works great for all IC'ers, stuff only goes wrong in one in a million cases, etc.

And I read an article like this one I posted, and it seems a lot more in line with what I am actually seeing on these boards - people having one problem after another with their interstims, it stops working, has to be reprogrammed a bunch of time, has to go back in for more operations, then there are stories like Dusty when the revision operations go horribly wrong. And that seems to be the NORM, at least for what I am reading on these boards.

And I'm thinking - why is there such a huge disconnect between what my doctors are telling me, and what I am actually hearing from patients who have had the interstim???

Doesn't make sense to me...something seems very fishy.

Anyway I am going in for my Bion to be implanted near my pudendal nerve. The device will become encased in scar tissue, they count on that in fact to keep the device in place.

The battery only lasts 5 years. What happens then? What happens when they have to go in and cut it out, cut through the scar tissue, right near the pudendal nerve like that?

I don't know. I don't think they know. I guess I will find out.

Anyway, I just posted that snippet because it was the first "official" thing I'd ever read that seemed to admit that there are some problems with the interstim in many cases.

Blessings, Lori

[ICLori]

Hi, Dusty. I'm so sorry for what you have gone through and what you are still going through.

Thank you so much for posting because these stories need so badly to be heard.

Oh, boy, the Bion.

Okay, before you start thinking I'm totally nuts, I want to explain what I've gone through with this horrible IC disease. How I've reached the point that I would willingly be a guinea pig for medical science.

I was diagnosed with this disease five years ago, following a bad UTI/kidney infection that somehow just never went away even though the bacteria stopped showing up. I still had the feeling that my bladder was full all the time, even right after I'd void. I was going sometimes every fifteen minutes, day and night. Couldn't sleep, you know the deal. No fun. Couldn't work, had to stop my job, couldn't have intimacy with my husband, hurt too bad. Couldn't enjoy life, have friends, anything, because I couldn't sleep, couldn't stop my bladder from feeling full constantly.

Tried every drug available, tried every OTC thing that anyone had said helped them. Tried homeopathic medicine, herbal remedies, pelvic floor therapy, TENS unit, narcotics, everything. Everything (except the TENS of course) seemed to either not work for me or in most cases make my urgency/frequency/irritable bladder worse. My bladder appears to be incredibly hypersensitive to medications.

So here I am with a bladder that only has a 450CC capacity under anesthesia, and a working capacity of only about 100cc or less before I have an intense urge to void. I do have some days that are somewhat better, and some days that are somewhat worse, but even my best days, I'm voiding 20-25 times per day/night, and spend hours each day with the horrible feeling that my bladder is always full. The worst part about all of this is how hard it is to fall asleep with that full bladder feeling. I don't fall asleep so much as I pass out briefly from exhaustion.

So after five years of this torture, you can see why I'd be pretty desperate to try anything to get better.

So my docs tell me, Interstim or bladder removal or live with it. And we don't like bladder removal, (and I can't live with this), so go for an interstim.

So I'm reading all the stories I can find on these boards. Not much useful information on the internet or the Medtronics site. But these boards (ICN) are very useful. So I'm reading, and I notice that the horror stories are a lot more frequent than the success stories. And that the success stories often turn into "it's not working for me anymore" very quickly. Then there are numerous reprogrammings, revisions, you name it. And sometimes people have the device removed completely, sometimes it ends up with horrible after-effects. And I'm only seeing one or two "good" stories where it helped people and continued helping them for years.

So I'm thinking - well, this is probably not a true representation of the proportion of failures/successes, because people tend to post more when something is bothering them, but even so...this doesn't look good.

But my docs are all saying, nothing bad like this ever happens, never heard of a horror story, yeah sometimes reprogrammings have to be done but that's not so bad, etc.

So I'm totally confused because what the docs are telling me, and what I'm reading on the boards, doesn't match at all. And the five-year adverse impact report isn't out, so how are any of us to know the real story?

Anyway, I'm sitting there talking to two uros about this. They mention a new device that's undergoing a trial, but at the time they mention it, it wasn't approved yet (through military channels) to be tested on IC patients.

This new device sounds a whole lot less invasive than the Interstim. The surgery to implant it is only done with iv sedation and local anesthetic, and the incision is only 3-4mm long. Very little trauma to the body going in, short healing time. That sounded good to me so far, sounded like a less difficult procedure than the one used to put the interstim in.

The device is very tiny. About the same size as a matchstick, only not as long as a matchstick, maybe 1/2 the length. Really small. I liked that too. Sounded better than a big interstim sticking out of me.

Then they told me it would be targeting only one of the branches of the pudendal nerve, and not the nerves in the spine. And that appealed to me, for several reasons. One was that I learned there wasn't any chance of the unpleasant legs/buttocks sensations that sometimes happen with interstim, because of the nerve it targets.

Another is that it kind of "covers" all of the sacral nerves instead of just one or two, meaning they've had success with the Bion where the Interstim has failed. That sounded good - sounded like they are targeting the nerve with the highest success rate.

This has been used in Europe for several years successfully, with no bad reports (that I'm hearing about anyway).

This study is really for urge incontinence patients, but they are allowing me to participate I guess for compassionate reasons.

It does send out electric shocks. I know what you are saying about jolts that hurt so bad because when they were doing the nerve stimulation test on me, when they had it in the wrong area with the power turned on, it hurt worse than anything I'd ever felt before in my life.

Anyway, I'm doing a lousy job explaining about the Bion I think, so let me go get a study to copy and paste here...

Blessings, Lori
P.S. I'm hoping everything turns out okay. I get it implanted March 1st. God help me.

Pudendal nerve stimulation for overactive bladder - Experimental Device

OB/GYN News, Feb 1, 2002 by Miriam E. Tucker

CHICAGO -- An experimental implanted device that delivers pudendal nerve stimulation holds promise for the treatment of refractory overactive bladder, Dr. Jerome L. Buller said at the annual meeting of the American Urogynecologic Society.

Afferent pudendal nerve stimulation has been shown to inhibit the micturition reflex, abolish uninhibited detrusor contractions, and increase bladder capacity; said Dr. Buller, chief of urogynecology at Walter Reed Army Medical Center, Washington.

Pudendal stimulation offers several advantages over currently available sacral neuromodulation: The device can be placed under local, rather than general, anesthesia.

It stimulates three sacral segments instead of one, thereby providing increased afferent input, which is believed to be important for neuromodulation.

Also, stimulating a peripheral nerve rather than a nerve root eliminates unpleasant stimulation of nerves in the buttocks and lower extremities, he said.

"Chronic pudendal nerve stimulation may provide a more precise and less invasive form of neuromodulation. ... I believe this thing has a lot of promise," Dr. Buller said of the device, which is known as the BION and is manufactured by Advanced Bionics Corp., Sylmar, Calif.

In a study sponsored by the company, a percutaneous stimulation test-using a stimulating electrode placed through the perineum to the pudendal nerve--was performed in seven women who had refractory overactive bladder.

Six had a positive response, with a mean 39% increase in maximum cystometric capacity.

Five of those six potential candidates underwent placement of the BION under local anesthesia. The device was inserted transperineally through a small introducing trocar, using a vaginal finger to guide it into place near the pudendal nerve at the ischial spine.

There were no perioperative complications, Dr. Buller reported at the meeting, which was cosponsored by Loyola University.

Patients received stimulation an average of 11.5 hours per day.

At 45 days, volume at first urge had increased by 31% and maximum cystometric capacity by 60%.

Voiding diaries revealed decreases of 57% in incontinent episodes, 23% in daytime voids, and 47% in nighttime voids, he said.

Pad use dropped from an average of 3.4 to 1.1 per day.

These clinical responses, though dramatic, did not reach statistical significance because of the small sample size. Study parameters returned to baseline after the stimulation was stopped, Dr. Buller noted.

The prototype microstimulator that was used in this trial had an external coil worn around the patient's hips and a controller worn around the shoulder or waist.

Future studies will be done using an entirely self-contained, implantable version of the device.

The company hopes to begin the final phase of testing in 2002.

COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group

[ICLori]

P.S. Jess, I didn't mean to make it sound like Interstim is all bad - they did report a 60% rate of it working, and even if the new figures aren't any better than that (and maybe they will be better) that's still a better success rate than some of the meds they are using now to treat IC.

The thing that scares me most about Interstim though to be honest is some of the stories I've read like Dusty's story and some others. I feel like when something goes wrong with these devices, it really goes wrong. And I would be lying if I said I wasn't scared to death of my own upcoming surgery, but I'm hoping and praying that things will work out somehow.

And - is it just me? - I just feel so confused because I've got doctors on the one hand making the interstim sound like it's so great, no problems, but then I come here on the boards and - wow.

Is it just me, or are other people having a hard time reconciling what they are told by doctors, with what they read here?

So I posted that because I thought - gosh, these revision rates are pretty high, almost 1/3 of patients have to have revisions, that's not what my doctors were making it sound like. And it was the first time I'd ever seen anything "official" where it seemed they were admitting that there were some problems sometimes.

And I thought, this is something interesting, maybe others would like to read this too.

Like you, I'm frustrated that we all can't get more studies, more percentages, current statistics. I feel like we are all just having to make these huge decisions without as much information as we really need.

Blessings, Lori

[ICNJess]

Dusty,

I am sorry if I came across as insensitive or rude. That was not my intention at all. I am very sorry that you were bombarded with nasty comments when you were having such troubles. That never should have occurred.

All I was meaning to say is that this is such a radical treatment, and there are such strong feelings on both sides. As Jill says with the InterStim, people either love it or hate it, there is no in between. Well, I am kind of in between right now, but that's another story.

Please accept my deepest apologies...I truly hope Medtronics puts updated numbers out there--that's really all I was trying to say. You can't learn anything from outdated numbers. Maybe with the updates the people whose InterStims have failed might be able to get some kind of acknowledgement? Again, I am very sorry if I offended you.

I also have multiple diseases and now with my stim on the fritz, I have constant lower back pain. (I have IC, IBS, Fibro, V.V., hormonal problems, depression...just to name a few, and I am 22 going on 90)

All I was really trying to say, and this was NOT a jab at anyone, is that I hope accurate figures are soon made available. When Jill and I talked some time ago, she said they were overdue--and there just isn't any excuse for that that I can see. That's all I meant.

[ICLori]

Another link I found interesting. Seems to draw on more recent studies. Interesting that they admit that the resurgery/revision rate is very high on this...that's something the docs don't seem to want to tell us...but is apparently well known...

Blessings, Lori

http://www.surgeons.org/asernip-s/net-s/procedures/SNS%20Urge%20Incontinence.pdf