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Reporting Interstim Failures to FDA

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  • KellyB
    replied
    Hi,
    I had the interstim surgery one year ago and it has been wonderful. I was going to the bathroom between 30 and 40 times a day and I never had to cath. I now only go around 7 or 8 times. It has changed my life immensely and I would do it again in a second. The surgery is a piece of cake. It has not done anything for my pain but as far as I am concerned half the battle has been won. I would rather only have to go to bathroom the few times that I do now and not get up at all during the night and be in pain than peeing every ten minutes and in pain. I hope this helps. Love, KellyB

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  • Sandy
    replied
    I just re read my post and I would like to clarify, although I still have SOME problems with urg/frg, it is not like it was a year ago and as far as retention it is not the same as before the implant either. Each adjustment I have had has changed some for me , but it is still new to the body yet. This time last year I was usually with a foley cath,becauseif I self cath (in and out) I would have to go again in 5 min and there was nothing in there.Now if I really control my diet and TRY to keep the stress level down I do pretty good. I can have a flareless day and eat the wrong thing or have something worry me and it flares or whatever it does and I get the pelvic burn and the urge to have to go to the bathroom again. Ex. Today, a friend was to be transferredfrom one hosp to another then it got cancelled, he got upset and was talking to me about it and thenabout an hour later my bladder started to bother me. That and the ribs and sauce I had for dinner I quess. Now it s lots of water time again. When I flare I still have to cath to empty the bladder completely or it is very aggrivating and "burns" in the bladder

    Hope I explained things ok here. The long and short of it everyone reacts differently.
    Sandy

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  • Sandy
    replied
    Hi, I had interstim done in June and stillhave probls with urg/frg, but that I think is mainly casused by stress. I still get retention and have to cathat times. There are many differrent settings for the implant and it is a trial and error until the right setting is found. Its not a cure,but personally for me it has helped with urg/frq, pain,constipation. Now when I fall off the "healthy wagon" by eating things like choc,juk food or smoking then I will usually go into a flre 1 o2 days later. I hve also faound when I go into a flarre and can't pee I have to drank the unit up, that is what the remote is for. You have to play around with this. Teri, I think you would agree on this one. I had a good day today, but had ribs with a sauce and that has bothered me tonight. I also drank water that was not Evian(I have proven to myself that Evian is the only water that does not irrate the bladder)If the bladder is irrated even 100 ml of urine will irrate it, so then I cath it out or be in pain. Best to get rid of it and dilute as well. More water more peeing. It has bonly been 7 months now and I still and having to go in for adjustments, I know there are good days out there cause I've lived them. Like I said for me foods,beverages I have to watch and smoking is a no no. and do not become constipated. I hate cranking the thing up but you have to withstand the buzzing for at least 24hours(me) and things seem to get back on an even keel, and also like I said, NERVES play a BIG part on my situation. The pain that it helped me with was the high bloating pain. I still get bladder burn and urethra burn,but I think that is foods and nerves again.
    Hope this gives some informtion to some people. At least I can go out now and not have to run to the john or have the constant feeling of having to go. If you have the implant and go to the bathroom and your bladdy does not feel comfortable after peeing and you have the feeling that you haave not finished best to cath to get it all out, and not let it sit there and "cook". Just causes more problems down the road.ANYWAY, this is my story and this is what works for me.
    Sandy

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  • soccergirl
    replied
    hi Debbie,

    Thanks for letting me know, I appreciate it. I already know Judy and am very familiar with the procedure that she had done. She is just an angel and I am so happy that her pain has been taken away with that procedure she had done. I am NOT interested in that for myself. That is far more experimental than Interstim and more invasive than Interstim. And, after my interstim failure, I am not up for that at this point in my life. The only nerve stim I would try now is SANS which Jill thinks very highly of and I am so suprised that more patients have not tried that before Interstim or any other nerve stim surgery.

    (((((((((((((((DEBBIE)))))))))))))))

    Lisa

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  • DebbieB
    replied
    ~Lisa:~
    There is a new procedure call Synergy EZ that is like the InterStim that is for pain,there is a girl name JudyK that had this done this year ..
    My Urology is one of the invendor of the InterStim Implant..
    He is well known and travel all over the world teaching this procedure to other Urologist too!!!!
    I just thought you would like to know ok Lisa!

    Debbie


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  • soccergirl
    replied
    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

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  • Teri
    replied
    Kara~since my surgery I am now able to go to hockey games, movies, car trips and to a shopping mall without an immediate potty We bought a cottage on a small lake in the fall and it's an hour and half ride. Without the surgery it wouldn't have been possible to do any of these things, especially the cottage.

    I have had many many different types of surgeries and this one was a piece of cake. Just make sure they give you something before surgery to keep you from getting sick to your tummy~that was the only complaint that I had. And, I only needed 1 pain shot, and 2 pain pills for discomfort during my hospital stay.

    hugs teri

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  • Teri
    replied
    Lisa~I heard on the news over the week-end that medtronics has a device they are testing for pain, it's implanted like the interstim is....I'm hoping that they will beable to 'add a wire' to those of us with the interstim if this proves to be helpful. The device is planted in the cheek of your butt and you are wired at the end of your spine, just like the interstim. Is this the same one that you are talking about?????
    teri

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  • soccergirl
    replied
    Interstim DOES and CAN help pain for some patients and there have been people that have posted that it has relieved their pain. So, I do not understand why a few people keep posting that it does not help pain and that their doctors are incorrect it they tell them that it can. My main problem is pain and that was a big deciding factor in my decision to try the interstim surgery. Dr. Siegel, a leading expert on Interstim, mentioned in his "ICN Meet The Expert" chat that it CAN help pain. Please refer to a copy of that transcript on this site. He also has published study results showing that Interstim has helped patients with pain. I know a patient that was in severe pain and now is pain free from her surgery, she was an inspiration to me to try the surgery. Dr. Siegel told me that she is not the only with those outstanding pain results. I know another patient that also had the same results. Unfortunatly we don't all get so lucky.

    From my understanding there has not been clinical trials, only studies, on Interstim for pain but I heard from an Interstim rep. that there were going to be I guess because the study results showed promise. Please post if someone out there knows differently and I am not correct on this.

    For those that have had ANY kind of success with Interstim, pain or urinary dysfunction, I am very happy for you!!!!!!!

    Lisa

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  • Ruth N
    replied
    I am an IC patient who never had to cath and for whom interstim has been a success. My frequency is cut in half, I can sleep through the night and I have a life again. I still flare at times but even in a flare I can sleep at night and frequency is still pretty good. Interstim does not help pain and any doctor who tells you otherwise should not be your doctor.

    I too would not suggest that this surgery is for everyone, but it has dramatically changed my life for the better.

    I think it would be important to know how much improvement people who have had unsuccessful implants really had on the test stim. Are the protocols being carefully followed? Also, how much experience does the surgeon have with the implant and what is his success rate.

    I certainly have been surprised at times by posts which describe less than 50% improvement with the trial and yet the person is reccomended for permanent implant.

    Obviously there will always be treatment failures, and maybe interstim is not as good as some of us think it is. I would like to see a more careful analysis of treatment failures to help guide patients and physicians in knowing more about who should really have the implant.

    To those for whom the interstim has not worked I am so sorry and hope something will soon be found to make your life better.

    To those who are scared to have the surgery-don't do it unless and until you are comfortable with doing it.

    That said, I must also add that as surgeries go (and I have had many) it is pretty easy and not very painful. I think it takes more courage to live with IC every day than to try the interstim surgery-but only if you want to and understand the risks and that it might not work.

    May you all find relief and better days ahead. Ruth

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  • Guest's Avatar
    Guest replied
    Thank you Terri for the encouraging side of Interstim. I too am out of options, I go every hour and with my period every 10 minutes or less. I have tried it all except BCG, which I did not want to do. My symptoms of IC are livable but I am only 23 and I want to be able to make love to my fiance, soon to be husband with out peeing every 3 minutes. I'd like to be able to sit through a movie, ride in the car for more than 30 minutes with out having to find a rest stop, watch TV with out having to miss something, and work at least 2 hours with out having to run to the bathroom and interrupt what I am doing. I do have pain but it's not constant and I know that Interstim is not for that. My doc thought I would be a perfect for the Interstim becasue my main complaint is frequncy and urgerncy. I can live with the pain once in awhile, yeah it sucks but it's better than being in pain all of the time and part of my pain is the urgency which was relieved during the trial.

    I'm just scared of the surgery. Being put to sleep for a long time and such....all of the other nerves that go along with surgery.

    But I am goint through with this and I am trying to keep positive as my doctor is.


    Kara

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  • DebbieB
    replied
    Lisa, yes you are right I do not have IC but I do have Pelvic floor dysfunction and been ill with bladder problems over 18 years.
    I had 14 cystoscopic and 2 hydrodistention..
    Done instillation of DMSO and Heparin and been on Elmiron and all sort of medication that lead up to being misdiagnosed with IC .. Then the bladder muscle went, which I am refering to the urethra tube too!!!
    I ask to be the moderator on this board, was
    to give SUPPORT ,and to let them know what the surgery was about and to answer questions and to let them know I am here for them , I am in no WAY pushing anyone on here to do the InterStim at all !!!
    I know is does not help some ,but also there are some with great results and it is no means a cure for IC at all..
    Thanks Teri, and I sure did not want this to start any kind of problem on this board at all !!!!!!
    I am sorry Jill that this has started something !!
    It is most important to report any kind of problem for sure !!!!
    Debbie




    [This message has been edited by DebbieB (edited 02-12-2001).]

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  • soccergirl
    replied
    Thanks Maureen for your post, I agree because the majority of IC patients do not have to cath. I've had severe IC for about 10 years and am on disability for it and have never had to cath.

    Lisa

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  • Maureen
    replied
    I think that the success stories here on the board tend to be more from people who had to use a catheter on a regular basis before the implant. Maybe we need to here from more success that were not in that situation.
    I still believe that you also have to determine what is your goal and what is sucess for you. My bladder went from holding 35-50 ml to holding 110m ml. This is still barely normal. It depends on the individual if they feel that is a sucess. If it is complete recovery and you have IC, I do not think you will get it from the interstim.

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  • Teri
    replied
    Boy Jill, looks like an interstim debate coming up

    I am a complete interstim sucess. I had my surgery done in Sept 1999. My symptoms were urgency, frequency, retention, and pain. I had been thru all the oral meds available but they caused retention, therefore, meds for me are ruled out, even to this day. I had so many different combos of DMSO that I can't remember. I was having cysto's and hydrodilations every 6-9 months. I had tried everything except the BCG. My uro said that the lining of my bladder was bad enough and he didn't want to even try it. I had an 'x' uro who cauterized my bladder lining 'in hopes' that it would regrow healthy.....dropped that guy, to this day I blame him for the pain I've been in since 1994.

    I was house bound from the time I had my bladder suspension in 1994 until my surgery in 1999 because I was going to the bathroom every 15=20 minutes. I was also cathing 3 to 4 times a day. My life was a living hell.

    When the interstim was offered to me, I was out of options and had nothing to loose. I was totally shocked when I learned that a 'normal' person pees 5-7 times a day. I didn't have a clue that I was "THAT" different. My hubby and I thought long and hard before we took the step and made the decision to have something so permanent done. I was scared to death but honestly, I felt that I had nothing to loose because I wasn't really living anyway.

    The surgery for me has changed my life 100%. I am one of the lucky ones and my heart breaks for the people who don't get the relief that I have gotten from the surgery. I still have bad days.....the surgery hasn't given me a 'normal' bladder. I still have IC. I still have some nights where I get up 5 times to pee (last night was one). There are still days when I have to self cath. I am NOT CURED. But, my symptoms are sooooooo much easier to live with now.

    I still can't let a baby sit on my tummy. I still can't wear jeans unless they are loose fitting (found that buying tall sizes helps me there) and there are days that I can't even stand to have the feel of underware on, but my syptoms are still 100% better and my quality of life is 100% better than before my surgery.

    Today I am a pain patient. No more pills for this or that. Praying for the miracle drug that will help me with my IC ~ the interstim has been my miracle. I still pray for the cure, but the interstim HAS been a great sucess for me and I DEFINATELY have IC.

    This implant was never even intended to treat IC. I think that that point has been made here time and time again. This is such a personal decision and it should be made with your family and dr, not by any of us posting here. Our posts are to share our story of what this implant has or HAS NOT done for each person.......NO ONE here is or ever has suggested that anyone should or shouldn't have this surgery, WE ARE SHARING 'OUR OWN STORY', NOT GIVING MEDICAL ADVICE and I think it's so important for every one on the board to remember that.

    Jill is so right. It's important that ALL the results of the interstim in regard to IC be reported. Nothing should be held back, good, bad or indifferent. It's important for the FDA to know. We ALL want a cure. It's thru trial and error that someday there will be a cure.

    Sorry to have gotten up on a soap box here. I am passionate about IC and all who suffer with this stinkin' disease, with ANY disease. Debbie has done a wonderful job on this board. She has been totally open and honest. She has given her story from a different bladder problem.....I am giving mine as an interstitial cystitis patient. We are ALL sisters with a bladder disease, doesn't really matter what name we have infront of it. What matters is that we are here for each other........

    Hugs to ALL teri

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