Anyone know about the bion?

[AmandaRN]

My doctor is going to do a clinical trial of the bion. he wants me to consider having the bion implanted instead of the interstim that is typically done. From his description of the bion, I'm all for it. It sounds great. Does anyone have one or know of someone who does. Does it help with pain. Pain is my major symptom and the interstim isn't for pain. My uro said the bion is already being used overseas. I would love to hear from someone who has it, because I am planning to get it. Thanks

[ICNJess]

I know nothing about it, but--ICLori, a gal around here, just had her's put in--try PMing her, she'd probably love to help, she's so sweet.

Hugs,
Jess

[ICLori]

Hi, guys! Here I am, LOL. I actually haven't had it implanted yet - I only did the test phase of it.

You know how Interstim has the trial to see if the device will help you, and then if it helps enough, you get the real device implanted in you?

They do something like that with the Bion, too, only it's not as big a deal as what you go through with Interstim, I think, because you don't have any wires hanging out of you for weeks or anything like that.

Here's my understanding so far of the process.

1. They take a medical history/do a quick exam to see if you have a problem with urgency/frequency and/or incontinence. (The studies they are doing right now are geared toward OAB/incontinence patients, we IC'ers are allowed in the testing process just as an afterthought or for compassionate reasons I guess. )

It was explained to me that the Bion claims only to be effective for urgency/frequency and the pain that comes as the bladder fills, not for other pain related to IC. In fact my doctor, who is really the greatest doctor on the planet, was adamant about me understanding that the Bion is NOT for pain but rather for urgency/frequency.

In my case, a quick vaginal exam was done by the doctor who would be working with me, to see if he could easily palpate my ischeal spine (where the pudendal nerve comes out of.) That's the physical marker they use to help guide the Bion in, and also to guide them when they place the needle for percutaneous nerve stimulation (testing phase.)

2. They have you read and sign the consent forms and educate you on the Bion and answer any questions you have about the procedure, the device, anything in general. They literally spend a good couple of hours with you doing this. Because you are part of an official study, the consent process is a little different than the normal process for other surgeries, etc. You have to agree to come back for a bunch of physical exams, for the first year, and then after the first year, they phone you regularly to get the info they need. So this is a 5-year process, where you jump when they say "jump." You don't just do the surgery then go home happy.

3. After completing a 5-day voiding diary, you come in for the testing phase of the Bion. During this procedure, the device is NOT implanted in you. It's simply a procedure to see whether or not the Bion might possibly help you. You need to budget approximately 3-4 hours for this testing phase. It's not surgery, you are not given anything but a local anesthetic, and you can drive yourself home after the procedure.

First they have you void, then they catheterize you to make sure you are not retaining (retention is another problem the Bion does not help with.)

Then they slowly fill your bladder with water, and you indicate when you first begin to feel a sensation of your bladder filling; when you first have an urge to void; and when you can't stand it anymore and are in pain from needing to void.

This establishes the baseline bladder capacity, without any stimulation. This tells the doctors exactly what shape your bladder is in, as far as being able to store urine.

Next, they straight-cath around the smaller catheter, in order to drain your bladder. They measure the total amount of fluid that was held in your bladder.

At this point, an anal catheter is inserted and several electrodes are attached to the perineal region, and one to your leg. A local anesthetic is administered to the perineal region, which feels about like any local anesthetic does - brief stinging sensation then it's over quickly.

Once you are numbed up, a needle attached to an electrical stimulator is passed through the perineal region (the left side of it is where they usually do it , unless there is some reason to use the right side, because most doctors are right-handed and it's easier to do the left side). When they did this to me, I didn't feel the needle going in or anything. No big deal at all.

Then they turn on the electrical stimulation, and you report what you feel. For me, this is where it got really ugly. They had told me that the local anesthetic would be the worst of it - I was not prepared for the level of pain I would experience with electrical stimulation of my nerves. I can honestly say it was the worst pain I have ever experienced in my life - and I have done multiple kidney stones, had my eardrums burst from infection, etc. so I know what pain is.

So if they tell you that part of the test won't hurt or will only be mildly uncomfortable - don't believe them.

When the needle was in exactly the right spot, and the stimulation not too high, all I felt was a tapping/knocking sensation "down there."

The problem was, if I so much as breathed, or if blood pulsed through my veins, or if the earth rotated slightly on its axis, the needle moved out of the right spot and they lost the reaction they were looking for on the computer screen. They were looking for a certain signal on the screen, indicating the needle was in the right place, and they kept losing it.

So they'd pull the needle part-way out, push it back in, wiggle it around, etc. While they were doing this, it caused extremely intense pain. They did this many times, probably dozens of times. If they had simply turned down the stimulation while they were moving the needle around, it probably would not have been painful for me, but they were in too much of a hurry to do that, or else they did not believe that I was in that much pain and thought I was just being a drama queen, not sure which.

Needless to say I was in tears and yelling "turn it down turn it down" all the time. It was a very traumatic experience for me. The doctor started in on me while I was reacting, saying, "we're doing this for you, you know." I could tell he thought I was just being a big baby about the whole thing.

Once they finally got the needle in the right spot, and I was feeling what I was supposed to and they were getting the reaction on the computer screen they were looking for, the device was left in place, stimulating me 5 seconds on, 5 seconds off, for...I think it was fifteen minutes.

After that, they again filled my bladder and recorded sensations, like before. They compared the post-stimulation figures to the pre-stimulation figures. If there was at least a 50% improvement in capacity, I would be considered a good candidate for the Bion. In my case, I met the criteria and was a good candidate.

Now I am waiting to be implanted. I don't know when exactly this will happen, as they are waiting for my device to be manufactured, but I am guessing maybe February or March.

BTW, once they turn the stimulation off/remove the needle, there is no pain whatsoever. I wasn't sore afterwards, or anything. In fact my bladder felt unusually comfortable for several hours afterwards, because of the lingering effects of the stimulation. I actually went for about 3 1/2 hours without needing to void once.

I hope this helps answer some questions...please feel free to PM me or page me here on the message boards if there is anything I can do, or any questions I can answer for you, I'm more than happy to help.

Blessings, Lori

[ICLori]

P.S. One of the things that attracted me to the Bion rather than Interstim are that the surgery is nothing compared to Interstim surgery. All they do is make an extremely tiny incision in your perineal region (so small you don't even need any stitches, just a little bandage) and insert the Bion with a needle/syringe type device. I've been told the procedure is very quick, and most patients don't report much pain afterwards at all, since the incision is so tiny. A nice young lady named Liz on this board actually had the Bion implanted, she knows way more than me so she'd be a better one to PM. She's really nice and helpful, I know she will help you too.

Another thing that made me like the Bion more is that when they do interstim, they only work with some of the sacral nerves. When you deal with the pudendal nerve instead, that's the main nerve that feeds into all the sacral nerves, so you are getting closer to the pain source and stopping it at its source instead of further up the nerve chain, so to speak. It just sounded to me like it might be more effective for Interstim. In fact I read a study that concluded that those who were not helped by Interstim, are sometimes helped by the Bion. Everything I've read about the Bion seems very positive and I personally am less afraid of the Bion than Interstim. Maybe I'm being foolish and naive, because things could always go terribly wrong, but I am hoping the Bion will help me. If I can just get through the surgery, LOL! I have to admit after the testing phase I'm pretty scared.

[curlycue]

Hey this bion souns great! one thing I dont understand. Is this being used for pain or frequency! or both.

[ICLori]

Hi, Ruth, like the Interstim, the Bion is only being tested for urgency/frequency. My doctor made sure I knew it was NOT for pain. He was very clear about that.

My pain tends to come mostly as a result of my bladder filling - even a half an ounce can make my bladder hurt - and I was told the Bion CAN help with that sort of pain, because it increases the amount of urine your bladder can comfortably store. So what happens is, it takes longer for your body to get that full bladder/painful bladder feeling resulting from filling of the bladder.

If your pain is constant and not related to the bladder filling, but instead from Hunner's ulcers etc, then the Bion would not be expected to help at all.

Hope that explains things a bit...

Yeah, I thought the Bion sounded less invasive, less extensive surgery, much smaller implant...all around sounded to me like less could go wrong.

Of course, it is a new device (although it's been in use in Europe with positive results) so anything could happen. Anytime a person volunteers to be a guinea pig...well....

Blessings, Lori

[curlycue]

Lori,
How do you feel. My problem is getting up around 5-8 times a night and I am tired of it! I am on Elmrion and Prozac and it has helped for about 2yrs but I am feeling the frequency comming on again. I do feel that same bladder symptoms you feel. Does the same company that makes Interstim make bion!

[ICLori]

Hi, Ruth! I'm not sure if I was clear about this in my posts, but I do NOT have the Bion in me right now. All I had was one 15-minute period of stimulation with a needle stuck into me at my pudendal nerve, to see if Bion WOULD help when it got implanted.

So since I do not have any neuromodulation device in me right now, I am not receiving any benefit, obviously, LOL!

When they put the Bion in me, I do hope it cuts way back on my urgency/frequency.

Some days I do pretty well (right after my period, for instance) and only go about 20 times in 24 hours. Other days (most often) it's 30-40. Some days 50-60, especially if I have a UTI at the same time as the IC which happens to me all too often.

I'm like you, getting up from 5-6 times at night (on my best nights) to 20 times a night. Not much good quality sleep there.

I'm not sure if you live near a testing center where they are testing the Bion - they are only doing these tests in a few places in the U.S. It's not commercially available, unlike the Interstim. Anyone can go get Interstim - with the Bion, since it's not FDA-approved and is only being studied now, you have to be part of a special research study in order to receive it.

So right now, the average IC patient can not go to their doctor and say "I want to try the Bion." If they are living near one of the few places where the tests are being conducted (Washington, D.C., some place in California, and I think one other place) then they can try to see if they can be included in the study.

On the other hand, it's pretty easy to get the Interstim, just about every hospital does those since the Interstim is FDA-approved.

Blessings, Lori

[ICLori]

P.S. The Bion is made by a completely different company than the Interstim.

Blessings, Lori

[curlycue]

Lori,
I live in Mira Loma California souther part 1 hour from San Diego. I wonder how I can obtaine info on the Bion! Let us know how you do once the bion is in.

[ICLori]

Hi, Ruth, here is some info including contact numbers...

Blessings, Lori


Home | Search | Browse | Resources | Help | What's New | About

An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

This study is currently recruiting patients.

Sponsored by: Advanced Bionics
Information provided by: Advanced Bionics


Purpose


Millions in the United States suffer from embarrassing and frustrating bladder control problems such as urinary urge incontinence. Urinary urge incontinence is typically defined as strong and sudden urges to urinate followed by sudden losses (leaks) of urine. Conservative therapies such as Kegel exercises, behavioral therapy and medications work well for many patients, but some remain refractory (or have not received benefit from these conservative therapies).

This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies. The device, weighing less than 0.03 ounces and measuring 1.0” x 0.1”, stimulates a nerve located in the pelvic region, called the pudendal nerve. It is hoped that stimulation of this nerve can reduce urge and unwanted urination.


Condition Treatment or Intervention Phase
Urinary Incontinence
Device: battery powered bion microstimulator
Phase III


MedlinePlus related topics: Urinary Incontinence


Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title: Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Further Study Details:

Expected Total Enrollment: 110
Study start: June 2003


Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Participation in this study will be approximately one year of clinic follow-up visits and annual telephone follow-ups for 4 years.

Location and Contact Information


California
The Department of Urology, Stanford University Medical Center, Stanford, California, 94305-5118, United States; Recruiting
Christine Chan, MD 650-498-4240 cac411@stanford.edu
Rodney U Anderson, MD, Principal Investigator
Chris Payne, MD, Sub-Investigator


Colorado
Urogynecology Associates of Colorado, Denver, Colorado, 80220, United States; Recruiting
Mary Doyle 303-322-0500 mdoyle@viawest.net
Oscar Aguirre, MD, Principal Investigator


District of Columbia
Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery, Washington, District of Columbia, 20307-5001, United States; Recruiting
Kathleen Noel, RN, MS 202-782-8456 kathleen.noel@na.amedd.army.mil
Jerome Buller, MD, Principal Investigator


Kansas
The Urogynecology Center, Overland Park Regional Medical Center, Overland Park, Kansas, 66215, United States; No longer recruiting
More Information

Study ID Numbers: CR-B-001, Rev. G
Record last reviewed: June 2004
Record first received: April 1, 2004
ClinicalTrials.gov Identifier: NCT00080470
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-01-17

U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act

[ICLori]

P.S. Even though it says the study is for incontinence, my doctor is letting me try it for urgency/frequency of IC. I am not incontinent.

I am their first IC patient they are trying this on. Even though I have told the nurse many times over that I am not incontinent and never leak, every single time she sees me she offers me continence pads and asks me to put down in the diary how many times per day I am "leaking." Rolls eyes.

Blessings, Lori

[curlycue]

thanks alot