Getting my Bion implanted 1 March 2005

[ICLori]

I'm so happy! I got a surgery date, 1 March 2005. I'm nervous and excited. I am hoping the implant will work, won't be too painful, and that I won't have any bad side effects from all of it.

This is very experimental, especially with IC patients, as it's been used mostly to treat urge incontinence up until now. So I'm really being a guinea pig but I am hoping it will work for me, and someday too for other IC patients.

Blessings, Lori

[Dixiefireball]

wishing you lots of luck sending you out many hugs and prayers
Rhonda

[Babs RN]

Yay Lori! :woohoo: I hope it helps you regain your life and will be praying for that. :) :grouphug: :smile tee :flower:

[kadi]

Will be praying for you & wishing you better days soon!!!

[ICLori]

Thank you, everyone! I'm hoping the Bion will turn out to have more positive results for IC'ers than the interstim.

Blessings, Lori

[vm]

Good luck!!! :) :) :)

[ICLori]

Thank you! I will have to wait 1-2 weeks for it to be turned on. Then...I don't know. I guess there is one group (half the patients) who don't get stimulation for the first 45 days. That wasn't in the paperwork I read...or maybe I'm getting senile...anyway...so I guess it will really be up in the air as to whether or not I'll be feeling better soon.

I just hope they can get the Bion in the right spot with me. They had a really terrible time of it during the test stimulation trial. It was a very small "sweet spot" that they had to hit - the nurse said that most of the time, they can move the needle lots and still be in the right spot, but with me, the slightest movement and they were in the wrong place. So I am very apprehensive about that - about them being able to get the Bion in the right place and it being able to help me as opposed to making my leg twitch (like during the trial), making me lose control of my bowels and bladder, or giving me more pain than I can cope with.

Blessings, Lori

[Tami Stambaugh]

Best wishes to you!!!!!!!!! I am sure you will do great!!!! Just keep a positive attitude and that will help tremendousley!!!! Hopefully they will hit your "sweet spot"!!!

Tami

[ads]

I wish you the best with the Bion. It seems like a neat concept. Can you tell us where are you getting it done and the doctor? A person on the pudendal board was asking me about it -- couldn't find any links or info.

Again, I hope this provide you with relief!

ads

[ICLori]

Thanks, everyone.

Ads, it's an experimental (non-FDA approved) device/treatment that is currently being tested on urge incontinence patients. Because it seems to be effective in treating urgency/frequency and that is my chief complaint, it is being used on me for testing and compassionate reasons. Although the trial is officially for urge incontinence, around the nation, there are several IC'ers who have taken part in the trials.

It is not a device that you can walk into a doctor's office or hospital and ask for yet. It is not like the Interstim, which is commercially available everywhere in the country now. It is still under investigation and under a trial, and there are only a few places in the U.S. (certain hospitals) where the principal investigators of this are holding trials.

I am fortunate in that the hospital I went to to inquire about Interstim, is one of those hospitals holding the trial for the Bion. This hospital can only be used by active duty military or their dependents (spouses, children, etc.) so it's not something that just anyone can sign up for.

There are a couple of other hospitals doing this throughout the country, though, that are civilian hospitals. For instance, there is one place in California where they are doing this trial too. I really don't know very much about it or where else they are doing these trials.

Anyway, unfortunately, it's not something that an IC patient can just say, "Oh, I want a Bion instead doctor" because it's still under trial - not FDA-approved - and not available to the general public. Anyway, that's probably why you can't find any links or info on this. It's still too new, and still not FDA-approved.

HTHS
Blessings, Lori

[ads]

Lori,

Thank you for taking the time to educate us! That was very kind. I hope to see you post this is an answer to your problem.

Take care,
ads

[Tami Stambaugh]

Lori,

Sounds like a great treatment for IC. Thanks for the information, I am sure that people with IC with find it very helpful with their treatment options. Sometimes patients are the first to learn about new medical technology and bring it to their doctor's attention. We just need more doctor's who understand IC and want learn all they can about it and new ways to treat it!!! I am very blessed to have a doctor who is like that and for those of you who don't my heart goes out to you!!!!!!!!! Keep everyone informed of your progress. Best wishes always!!!!!!!!!!!!

Tami

[ICLori]

Thank you both so much!

I have high hopes for this. I am hoping so much that it might be something that helps more IC'ers, with less bad results, than the interstim.

I felt that in at least one way it seems more promising, in that it targets the pudendal nerve directly instead of the sacral nerves. I might be misunderstanding things, but I'm under the impression that getting the pudendal nerve is even better than the sacral nerves, because the pudendal nerve feeds into the sacral nerves. So you sort of cut the "bad" signals off sooner and maybe fewer of the "bad" signals can climb up to the brain. (Well that's a really medical-sounding explanation, lol!)

They think it could work better for urge incontinence patients and urgency/frequency patients than the interstim does. If it does (earlier trials in Europe seem to support this conclusion) then that is a step in the right direction for sure.

It also seems much less invasive, it's such a small device, much smaller than the Interstim, tinier than a matchstick even. So it's much less trauma to the body to place it or take it out.

But, if things go horribly wrong, it's just as bad as the interstim. You could get permanent nerve damage, lose control of bladder and bowels, etc. It's not something they think will happen, but it could happen. So all I can do is hope that this very rare event will not happen to me. I get the impression that there are fewer adverse events associated with this than the Interstim, but...well, with such a new device, and only data out of Europe really, which is hard to chase down on the internet (I don't speak Dutch, which means I can't read half the reports out there on this...) there's no way I can get a really good feel for exactly what the odds are that something could go wrong.

I feel bad on the one hand that everyone can't run out and get this device. Then a thought pops into my head, "this isn't FDA-approved yet, what if there are risks that we don't know about, what if it goes horribly wrong for many patients..." and I think, it's best that only a few of us are guinea pigs for now.

One thing that's kind of interesting is that the trials for these devices seem to be much more painful for IC patients than for non-IC patients, in general. I guess it's because our nerves are so up-regulated, neurogenic inflammation, something like that.

I'm the first one to admit, I'm scared to death of the surgery. Really looking forward to it becase I think the Bion will give me my life back, but really scared of the pain at the same time, and worried they won't get it in the right spot or that something will go wrong.

I guess everyone is nervous before surgery, it's normal.

Blessings, Lori

[ICLori]

P.S. Here's some more info about it. The device they describe in this article is the older prototype - the newer one is battery-powered and you don't have to wear the coil or anything.

Blessings, Lori

Pudendal nerve stimulation for overactive bladder - Experimental Device
OB/GYN News, Feb 1, 2002 by Miriam E. Tucker
Save a personal copy of this article and quickly find it again with Furl.net. Get started now. (It's free.)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]

More information at this link...kind of similar to the article above but in more depth.

I found it interesting that the article stated that reoperation rates remain high for the interstim - mostly due to lead wires migrating and pain. !!! Let's hope the Bion works better...

Blessings, Lori

http://64.233.161.104/search?q=cache:bXOK_Iw91JYJ:www.vard.org/jour/01/38/6/pdf/grill.pdf+side+effects+of+chronic+pudendal+nerve+stimulation&hl=en

[ICLori]

Well, now my surgery date is tomorrow, and I'm kind of nervous about it. I hope it won't be horribly painful. I hope they give me enough Versed that I won't remember any of it.

I had to call the Patient Representative to make sure that the pain management doc I had a run-in with last summer will not be doing my anesthesia. The patient rep tried to tell me I should talk with the doc directly, and I said that wasn't possible, that things ended with the doctor walking out on me after chewing me out and there wasn't any way I could speak with her now. I said, too, that that doctor would probably perversely make sure she was my anesthesiologist, if I asked her not to be - just to make me uncomfortable.

Anyway, I could tell the patient rep was ****** about having to go to pain management to speak with them, but he agreed to go try to make sure she wouldn't be doing my anesthesia.

I'm waiting now for a call back from the patient rep.

I will be undergoing the procedure at 8:00 A.M. (I'm lucky, first on the schedule!) and so I will have to be there at Walter Reed at 5:30 A.M.

Did anyone else have to take a laxative kit to clean themselves out prior to implant surgery? I guess they are worried about hitting the wrong nerve and me having a bm on the table maybe...or hitting a nerve and damaging it and me losing control forever of my bladder and bowel function. Sheesh I hope that particular possible side effect won't happen to me.

This is the way I am thinking about this operation - if it works, great. If it doesn't work, at least I've really shown the doctors that I've tried everything, so they will be more willing to consider cystectomy for me. If it leaves me worse off than before...I will be very sad and will wish I hadn't taken such a chance, but I will be glad it happened to me and not to my other IC sisters and brothers.

Blessings, Lori

[Babs RN]

Lori,
I hope things go well for you, as I'm sure they will. Will keep you in my prayers for a speedy recovery.

Hugs,
Barb :kissing:

[ICLori]

Thank you so much. It's nice to know I won't be "alone" in this. Thank God for this site.

I'll probably feel really relieved once the thing is in me. I'm just kind of a coward about the pain. I hope I won't cry and make a fool out of myself like I did for the nerve stimulation test. I heard the surgery hurts a lot worse than the test, so I'm kind of bracing myself for it.

Thanks for the support...I really appreciate it. The resident I saw the other day for my pre-op was really great - he listened to me and asked lots of questions about IC...I told him about these message boards. I have hopes that soon good doctors like him will be the norm and we won't have to deal with doctors who do us more harm than good.

Blessings, Lori

[mallenajolie]

Hi Lori:

Good luck tommorow! I know someone who had this done, and had great results. Just think positive! Kudos to you for being in a research project! I don't have the guts. But I have this continous black cloud over my head, and it probably wouldn't work. I have severe retention, and I see it is contriindicated (spelling??). Enough about me, I will be thinking of you tomorow..my cats send kitty hugs!!

[vm]

Lori - Good luck, good luck, good luck and TONS of good vibes and prayers headed your way!!!!!!!!!!!!!!!!! :kissing: :kissing: :kissing: We're all behind you here! :) (Is that 8am eastern time or are you somewhere else?)

[ICLori]

Thank you all so much, you guys are the greatest! It sure cheers me up to see you guys wishing me good luck. I'm hoping so much that this device will work better for IC patients than other devices, will have fewer side effects and more success I hope.

I'm in the Eastern time zone....lots of snow here today, hope they don't cancel the surgery or anything because of snow.

Thank you all again so much. I'm sure I'll be just fine, I'll just try to be a little tougher and get through it when it hurts.

Blessings, Lori

[ICLori]

Thank you Jane!

I never heard back from the patient rep (who acted like it was a huge favor to be doing his job) so I assume he never worked anything out regarding the anesthesiologist I wish to avoid. I'll bet that if anything, Dr. S. will insist on being the one to give me anesthesia just to make me uncomfortable....

You know what's ironic? I tried one of my hubby's Flexeril pills today - totally got rid of all the symptoms like magic (my bladder has been acting up badly lately).

If I had known that Flexeril could work so well for my IC symptoms, I would have just taken that and not gone looking for the Bion. But now I'm pretty much committed and it's too late to back out now.

I will ask the doctor tomorrow if he'll prescribe Flexeril for me, though - tell him that I found it to be very effective for my symptoms . He did say that except for when I'm doing the voiding diary, I can stay on any meds that help me...so I will ask him to prescribe Flexeril.

Blessings, Lori

[ads]

Lori,

You always have the right to say no at anytime, even 5 min. before surgery. That is patient's right. Doctors have rights and so do patients. If Flexeril (sp?) works for you perhaps you have pelvic floor dysfunction, which Dr. Robert Moldwin's book covers in detail.

I wish you the best and relief soon!

ads

[ICLori]

I don't really trust Flexeril to keep working for me...maybe it's just placebo effect. Anyway I've come this far, I'm going to go through with this....

Man I'm so scared though. I heard the operation for this is even more painful than the testing was and the testing was brutal.

I don't have pelvic floor dysfunction - was tested by a PT for that - flexeril's main action is as a muscle relaxer, but it has a side effect and composition very similar to the tricyclic antidepressants, in that it stops the nerve endings from sending the pain signals so loudly. So it's that benefit, not the muscle-relaxing part, that is helping me.

Oh I wish I had something like pelvic floor dysfunction that could be easily fixed - but I don't, the physical therapist hooked me up to all kinds of machines and tested for that. I have plain old IC, with a bladder that's become nothing but a bag of scar tissue that hurts all the time.

I'm really really not looking forward to this operation, I woke up an hour early this morning than I meant to (it's about 2:30 est now) and I've been just crying thinking about how much this is going to hurt and wishing that I could just be knocked out for this.

Oh, well, maybe it will be worth it in the long run, maybe this will work for me.

Blessings, Lori

[ads]

Lori,

It sounds like you have to be awake during the surgery and feel pain so they can adjust the device, but afterwards, they should provide you with ample pain relief. If they do not, report it to higher ranking doc or call patient relations in. You have a right to adequate pain control. I guess there isn't much that can be done during the instillation.

I will be thinking about you and hope the surgery is done quickly.

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[rubjen]

lori, good luck today.i'll be praying for you.an GOD WILL BE WITH YOU.
RUBY JEAN

[SharonA]

Lori... :kissing:

I hope things are going well this morning and you have a quick recovery. I hope this device works for you. :) :) :)

[Babs RN]

Lori,
I know today is the big day and just wanted to let you know I am thinking of you and praying for you.

Hugs and healing thoughts,
Barb :grouphug:

[ICLori]

Thank you all so much for the prayers and support, I appreciate them so very much!

Just wanted to let you guys know, the procedure went very smoothly, they gave me lots of Versed and what-not so that I'd be very relaxed. I did feel a few brief moments of pain while they were trying to find the right spot with the stimulation, but it wasn't anywhere near as bad as the testing phase and I was very relaxed so it was all just 100% easier. I am very relieved and happy that it wasn't at all difficult or traumatic for me.

The best news is, the doctor is very pleased with the placement of the device, what he was seeing on the screen and what I was reporting sensation-wise was exactly what he was hoping for, and we can be confident that the placement was correct and the response is very good so far.

So overall it went extremely well, I'm laughing at myself now for having been so worried. I'm a little bit sleepy from the anesthesia, I always find myself wanting to nap after I've had IV sedation, but I'm not feeling any pain at all. Although they did give me some pain meds to take in case I need them, I haven't needed them yet, I'm not in any pain at all (except the usual bladder discomfort that I always have, which I hope might be banished soon when my Bion is turned on.)

Thank you all so much for your kindness and prayers :)

Blessings, Lori

[Babs RN]

Yipee-I'm so glad you're ok, Lori! Please let me know if there is anything I can do for you.

Hugs,
Barb

[vm]

SOoooooo glad to hear it all went well and that you are feeling OK today. I truly hope this is the answer for you. :kissing:

[rubjen]

how's it going lori? i hope it is all you hoped for. lets us know please. ruby

[ICLori]

Hi, Rubjen, I'm healing up just fine (actually never had even a minute of discomfort from the surgery.)

I should explain, my device is not turned on right now. What they do with the Bion is, they implant it, then wait two weeks for the site to heal, before they turn the device on and set the parameters, etc.

And of course, to receive any benefit from the device, it has to be turned on - otherwise it's just this small lump of metal and circuitry sitting in your pelvis.

I think that I will have an appointment in another week or two to have it turned on.

But - depending on which group I am in - I may not receive stimulation for the first 45 days.

I am part of a study, to see if this device should be FDA-approved or not. So what they do, is half the group that receives the Bion gets it turned on but set to zero (no stimulation, no help) for the first 45 days after the two week healing period. The other half does get real stimulation after the first two weeks. Then the two groups switch, and the people who had stimulation, don't have it for 45 days. That is necesssary to prevent the placebo effect from happening. They want to really see if this device helps people or not.

Anyway, I have a 50-50 chance of getting the actual stimulation in about two weeks, and I will let you guys know then how it's going.

For now, my bladder symptoms are the same, because my device has not been turned on, and therefore is not working.

Blessings, Lori

[rubjen]

Thanks For The Update Keep Us Posted. It Is Soon Exciting That It Could Be What I C Ers Need. I Realize That Every Thing Does Not Work For Everyone.iwill Be Looking Forward To Your Turn On Date.good Luck An May You Find Blessed Relief From Ic.
Ruby Jean

The Task Ahead Of Us
Are Never As Great As
The Power Behind Us

[ICLori]

Just an update...

The Bion has had a tremendous effect on my urgency/frequency. I haven't started a voiding diary yet, but I think I'm not voiding any more often than normal women do.

It also seems to have at least a slight helpful effect on my pain - I spend fewer hours per day in pain, which is nice - but I am still struggling with pain at night that interferes with my sleep. I've been given Ambien, which works very well to shut the nerves up and to make me go to sleep, and I've been told that I shouldn't have a problem getting doctors in the future to continue to prescribe me Ambien.

I may see further reduction in my pain, the longer the device is in and on. It's probably not something that will happen overnight, so I'll try to be patient and hopeful.

If my experiences are anything to go by, the Bion might prove to be a whole lot better for IC patients than the Interstim. The implant surgery was a breeze, I've never even once had any painful leg sensations or shocks or anything like that, and so far it really has made a big improvement in my life, and hopefully will continue to get me better as more time passes.

Blessings, Lori

[rubjen]

hi lori,this is great news!!! i sure hope it helps with the pain ,I am getting the interstim soon,I can't wait for the Bion as I have to go about 80 times 24/7 day an night.i have become a prisoner in my own home. my family doctor told me to wear the thicker pads an go when i an out but i cannot wet myself,so it is pain time to try to hold it.i need to be out side an to work my garden an flowers.I can hardly wait for the inter stim I KNOW IT WILL HELP. I know it willnot help with the pain. keep on posting news about the Bion it is realy great news an there are others who will try it when it is aviable.
Ruby Jean

[green_the_fish]

Lori, this is so awesome for you! Now you're the Bionic woman :lmao:
I hope that your frequency/urgency symptoms stay down, and that your pain gets better bit by bit until nothing hurts anymore :)

[ICLori]

Thanks so much you guys - I hope so much too that the Bion proves to be very helpful for IC and, if so, that it becomes available on a widespread basis for IC patients.

It breaks my heart to read stories of patients who are suffering so much and haven't found anything yet that really helps. I can't help but hope that the Bion will make a difference for these people.

Ruby Jean, I hope the interstim works great for you. I think you will probably find that even just a big reduction in your frequency, will mean a better quality of life for you. And even though we know these devices aren't for pain, whenever I hear of anyone getting one of these, I always say a quick prayer that it might work for pain anyhow.

Blessings, Lori

P.S. Bionic woman - argh!!!! LOL!