continued.....Reporting Interstim Failures to FDA

[soccergirl]

Hi,

I noticed that this topic that started with ICN Mgr. Jill's post went on for two pages. I thought I would post my reply again in case someone may not realize it continues for two pages and that you have to click on page two to see more postings. Here is a copy of my post (by the way, I am not able to revise my postings once I have posted them. Anyone have a clue why?):

Hi Teri,

No, what I am talking about is Interstim, the same exact surgery that you had done. Please refer to Dr. Siegel's chat transcript. He has been doing interstim for about 11 years and was very important in getting Interstim FDA approved. I was first enrolled in his frequency/urgency study in 1994 so I know a lot of patients that have had the surgery. At that time, he was doing the study with Interstim for pain, and the study continued for many years. You can see a copy of published study results at the ICA website. The study is about Interstim for pain. It is included with the papers that were distributed at the National ICA Convention last October. I believe there are other published studies on Interstim for pain as well but I do not know off hand where you can find them. It is not FDA approved for pain at this point and I do not know if it will be.

I know everyone that posts on this topic is very passionate about helping others. I am just sharing my knowledge, in part, so people do not quit seeing their doctors if they tell them it may help their pain. This has been some advice posted. I mentioned two patients in my above post, they were CURED of all their IC symptoms (pain, urgency, frequency). They have not had any symptoms for years since having Interstim. I have know patients that have had partial success and I have known complete failures including awful outcomes requiring unsuccessful revisions as well. I decided to try the surgery despite the fact that I could not a long enough good trial because the wire kept moving on me. Of course, hind sight is 20/20 and I would not do that again or would I advise anyone else to. I was desperate as so many of us are.

Lisa

[Teri]

Lisa~I went back and I read the transcript with Dr Siegel.....dated Dec 16, 1999....I know that I've read it before but it was a good review for me. I hope others who have been involved in this discussion will go back and read it too
tons of hugs ~ teri

[soccergirl]

Hi Sandy,

I just read your post under the other topic, page 2. I am very glad for you and the results you've had. Once again, you are another person with positive results that had to cath. Yet another patient that posts with positive results is Rhonda who also cathed and I think still sometimes needs to even with her Interstim. I think that the clinical trials results say that Interstim works best for people retention problems. I am not going to go look at the study results again to verify this, so if someone looks it up and finds that I am wrong, please post. If I am correct on that, the posts on this message board would be evidence that is the case. One of the women that I know that was cured of IC (severe pain, frequency, urgency) from her Interstim surgery had a retention problem. When she had her trial put in, she told me that she went to the bathroom and peed a waterfall for the first time since having IC. I do not think she had to cath though. Cathing is not common among IC patients, and the majority of patients do not need to. I have freq/urg but I can often pee pretty large normal amounts with a fairly strong flow.

For some people with severe retention, the stimulator can work as well as "turning on a light switch" and now they can pee much larger amounts and get it out faster. If it works, the next thing, is to keep it working without needing a revision surgery, which about 30% of patients will need done from what I understand.

Again, if someone reads my posts and finds errors, please post. I never want to mislead anyone when they may be making such an important decision.

After talking to Jill and reading about SANS, I do not understand why people do not try that first. The success results are the same from my understanding and it is not a major surgery. Also, biofeedback when done consisently over a long period of time can also have good results as long as they are seeing a professional that understands IC. The problem is that patients are so desperate they want something to quickly provide relief and they do not want to try any more treatments that take time to work. This is understandable since so many of the IC treatments take FOREVER to work if they are going to. But, keep in mind, that Interstim can be somewhat of a quick fix (after the ajustments) but if it does not work, or stops working, you are left to pick up the pieces with many decisions to make about the equipment inside you. Your mind can be too tied up to diligently try another treatment. If that happens, it can hold you back from getting better for a very long time.

We all pray for those marvelous results we hear about I just wish that Interstim had more consistent, predicatable outcomes so it would not seem like such a gamble.

Just my two cents, from my own experience and from talking to other patients that have had the surgery. Best wishes to everyone.

Lisa

[Lorie]

SANS is something I have wanted to try for some time. Currently the co. that maks SANS supplies is not operational.There is supposed to be a new start up in a few months. Drs. do not seem to be very interested in doing SANS txs. There is no one in NJ who does SANS. My uro may be interested when co. starts mfg. supplies again. Much more money for Drs. in doing interstim I think that is a factor.

[DebbieB]

Hi: Lorie:
How true that is about the company that makes the SANS..
I ask about the SANS before I made the decision on doing the InterStim..
My doctor told me that it was having problems and that there were more money giving to the doctors doing the InterStim..
I am very happy that I did do the InterStim and have no regrets in doing it at all !!

~~~~Debbie~~~~~

[rhonda]

Hi, yep, I'm one that the interstim worked well with. I did have total retention for almost a year before having the interstim implant. Now I am able to go on my own most of the time. The times I have to cath are when I have a kidney stone or a major infection. The doctor told me it's really anytime my body goes into stress and the pain gets greater than the sensation of the implant. It was not blindly that I went into it though and probably would not have thought about having it done except due to the cathing and number of infections associated with it. Also, it was found in the test studies that I had nerve damage to some of the nerves and that's probably why it works so well with me.

[Ruth N]

For those of you who have not read it, please see my lengthy post in the original thread of this topic. For those who did not see it, I am an interstim success story and I never had to cath or had retention.

Regarding the SANS it was not available at the time of my interstim implant but obviously if it is available where you are it is certainly worth a try.

As I tried to suggest in my previous post part of the difficulty in assessing success rates is in being sure similar criteria are being used by the different doctors.

With regard to biofeedback and electric stim-again, of course that should be tried first. In fact, the interstim guidelines for frequency/urgency state that interstim must not be tried unless several medicines AND biofeedback/electric stim have been adequately tried and were unsuccessful.No doctor should be offering an interstim trial for frequency/urgency unless these other methods have been tried and failed. My doctor felt I was a good interstim candidate but insisted that I first go through biofeedback/electrical stim. In short he was following the FDA and Medtronic guidelines for Interstim.I went through a lengthy course with no improvement and yes I was having it done by someone competent.

Again, I am not urging anyone to have this surgery. In fact I again urge people not to have it unless they are totally comfortable with the idea and have had a truely successful trial as defined by the guidelines.

But as someone with a backgound in medical research I know how important it is to be sure that your data is clean and that the same objective measures are used across settings and practitioners. What we have on this board is all anectdotal and that is what this board is for. To use anecdotes as solid evidence for or against any treatment is ill advised.

Once again, may you all find relief in the days ahead and may your own personal comfor levels guide whatever treatment decisions you make.

[Sandy]

Originally posted by LisaM:
Hi Sandy,

I just read your post under the other topic, page 2. I am very glad for you and the results you've had. Once again, you are another person with positive results that had to cath. Yet another patient that posts with positive results is Rhonda who also cathed and I think still sometimes needs to even with her Interstim. I think that the clinical trials results say that Interstim works best for people retention problems. I am not going to go look at the study results again to verify this, so if someone looks it up and finds that I am wrong, please post. If I am correct on that, the posts on this message board would be evidence that is the case. One of the women that I know that was cured of IC (severe pain, frequency, urgency) from her Interstim surgery had a retention problem. When she had her trial put in, she told me that she went to the bathroom and peed a waterfall for the first time since having IC. I do not think she had to cath though. Cathing is not common among IC patients, and the majority of patients do not need to. I have freq/urg but I can often pee pretty large normal amounts with a fairly strong flow.

For some people with severe retention, the stimulator can work as well as "turning on a light switch" and now they can pee much larger amounts and get it out faster. If it works, the next thing, is to keep it working without needing a revision surgery, which about 30% of patients will need done from what I understand.

Again, if someone reads my posts and finds errors, please post. I never want to mislead anyone when they may be making such an important decision.

After talking to Jill and reading about SANS, I do not understand why people do not try that first. The success results are the same from my understanding and it is not a major surgery. Also, biofeedback when done consisently over a long period of time can also have good results as long as they are seeing a professional that understands IC. The problem is that patients are so desperate they want something to quickly provide relief and they do not want to try any more treatments that take time to work. This is understandable since so many of the IC treatments take FOREVER to work if they are going to. But, keep in mind, that Interstim can be somewhat of a quick fix (after the ajustments) but if it does not work, or stops working, you are left to pick up the pieces with many decisions to make about the equipment inside you. Your mind can be too tied up to diligently try another treatment. If that happens, it can hold you back from getting better for a very long time.

We all pray for those marvelous results we hear about I just wish that Interstim had more consistent, predicatable outcomes so it would not seem like such a gamble.

Just my two cents, from my own experience and from talking to other patients that have had the surgery. Best wishes to everyone.

Lisa

Hi Lisa, Yes I still have to cath most of the times when I am in a flare or have an infection. I still think there will always be adjustments as the body it self changes. Stress I would say is my BIGGEST problem. I don't know what it does to the bladder but if I get stressed I seem to get retention and the feeling of the top of the urethra that it has not let the bladder finish peeing. It is very hard to describe. I am also very sure smoking plays a big factor with me to.. I can only hope this gadget keeps working and I hope I have tthe willpower now to stay away from all the srong things ie choc smoking etc. Seems like when you get those good days you feel like oh well I will just have a few of these things and then it starts all over again. Hard learner I am, one day it will sink in to smarten up. This last flare up was bad so I cut out everything I could think of that could possibly be an irratent (sp) and hopefully have enough of the ant bio this time to clear the infection. What do you figure are going to be your next steps. I have often thought about what is the next step if the unit quits and I have to have it removed. I always figured the interstim was the all end all of treatments when everything else failed.
Sandy