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  • #31
    Tried to post this earlier, the site froze up on me...trying again. This is an old message, these places may no longer be recruiting for the FDA trial. As you can see, there aren't many places to begin with to get this done...

    And the place in DC, you can only get in the trial if you are a military dependent, so that leaves that place out for you....so the only places you could get this done are in Colorado or in California, and I'm not sure they are open anymore for this study..but you could call and ask, no harm in trying....

    Blessings,
    Lori

    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 [email protected]
    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 [email protected]
    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 [email protected]
    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

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    • #32
      Thanks Lori, just wondering. Having more problems with my new Interstim now, I am thinking of getting the whole stupid thing removed. Thanks again.
      God grant me the serinity to withstand the days ahead!!!

      My myspace link...
      www.myspace.com/patricia_luvs_matt


      Patricia

      In Memory of My Father (Lawerence) 1/25/2007

      Procedures:
      Interstim Sept 2001
      1st InterStim Removal May 2005
      2nd Interstim Implanted May 2005
      2nd InterStim Removed March 2007
      Hysterectomy 1999
      Tubes Tied 1997
      C-Section 1996


      Me and my kids


      Taylor (my daughter) Me and my daughter My son Cody and Taylor

      Comment


      • #33
        So many people have had problems with the Interstim...I hope so much the Bion or other similar devices are approved soon so that maybe there will be devices that won't have so many side effects.

        I'm really sorry the Interstim isn't working out so well for you. Please don't give up hope though, there are new treatments coming out all the time for IC...I'm going to be trying that cyclosporine-A soon, everyone thinks I'm crazy, but I've tried everything else and nothing has worked, and the studies look good on this, so I figure, I'll take my chances...

        Blessings,
        Lori

        Comment


        • #34
          Ic lori:
          i am so hopeful for you for this cyclosporin a.. i really think it sounds great.. according to the studies...
          i wonder why it has not gotten more attention..
          i wish you the best.. i know you will keep us all updated on it..
          will you have to go off of other drugs, if you are on any?
          Good Luck

          Comment


          • #35
            lori
            Before you had the bion in place, did you have retention as well as frequency and urgency and is the bion helping you? percentage wise how much do you think it is helping.. how long have you had it? are you pleased with the results so far. any problems with it?

            Comment


            • #36
              Hi, Wolfaleena, I'm not aware that I have to go off any drugs while I'm on Cyclosporine-A. I know I can't use any OTC pain relievers while I am on it, but I never use those these days anyways because they kill my bladder. Maybe I will learn more when I go see the doctor and get my prescription - I will also ask the pharmacist if it's okay for me to stay on the drugs I am currently on - birth control pills and high blood pressure meds. I'll let everyone know if I can't take those two with the Cyclosporine-A.

              I think part of the reason CyA hasn't gotten more attention prior to this is that it's riskier than other IC drugs. Any immunosuppressive drugs are risky. But from what I've been reading, in studies and also in people who use these drugs for other autoimmune conditions like lupus, RA, Crohn's, etc. the main risks are temporary kidney failure (reversible when you stop the meds) and hypertension (again reversible.) So I will be monitored weekly to watch for those things...probably for the first few months until they are sure I will be okay. And not everyone gets those side effects, of course. In the studies done for IC, the only side effects noted were two patients who developed hypertension (high blood pressure) and they went back to normal once the dose was reduced (but they kept the relief of symptoms even at the lower dose.)

              I'm very excited too about being able to try this drug, and I'm really not worried about the side effects.

              About the Bion---I didn't have any retention at all, either before the bion or now. I've never had retention.

              I would say it decreased my number of voids per day by about half - so it really did work well for the urgency/frequency part. Not so great for the pain. I think it did help with the pain somewhat - maybe 10 or 25%? Hard to tell. But it doesn't help me nearly enough.

              It's better than nothing, of course, but I was hoping for something that would leave me 100% normal, no bladder pain at all, and it didn't do that for me.

              I've had it a little over a year now. The battery lasts about five years.

              It's still in FDA trial - is not available to the general public, so this isn't a device you can go and ask for at your doctor, yet. Maybe in a few years, if it is approved by the FDA...

              Blessings,
              Lori

              Comment


              • #37
                Just wanted to update the update. My Bion has been turned off for 45 days now as part of the trial. I did a voiding diary, and found that my voids increased by only one void per day on average - not a significant difference.

                I'm not sure why there was not a significant difference - maybe I'm just in a semi-remission or something - but for now, I am not so certain the Bion helped me...I don't know what to think.

                Blessings,
                Lori

                Comment


                • #38
                  Lori,

                  I am so happy to hear that you are doing so well!:woohoo: I have my year visit with my bion on June 15th. This is my 2nd one and I think they may have finally got all the kinks out. Mine hasn't helped much with my pain, but I do notice a big difference in my urgency/frequency. I have to sart a voiding diary tomarrow, but I really think my bladder is holding alot more. The only problem I have just started having is retention and I am straining to go sometimes. It is like the muscles won't work to allow me to get a stream going or to empty completely, so I am a bit worried about that. I still have to take pain meds and ended up in the hospital in March because my pain was so bad, but I still have hope that maybe when I use it at a higher setting it will help more with my pain. Keep me posted!
                  Liz

                  Comment


                  • #39
                    Hi, Liz, since the Bion really didn't help me at all, I think I will just leave it turned off forever - no sense in wasting time charging the thing since it's not helping me anyway.

                    My next hope is that the Cyclosporine-A I was just prescribed will work.

                    I'm sorry to hear you aren't doing so well pain-wise - I hope things get better for you.

                    Blessings,
                    Lori

                    Comment


                    • #40
                      Help on Neurostimulators

                      My mother has been diagnosed with IC and I've been reading the postings about neurostimulators. Her doctor mentioned Medtronic, but not Bion. Is Bion available nationwide? I live in a rural area, maybe that's the problem.

                      Comment


                      • #41
                        Re: Update on my Bion

                        Lori, please contact me. I have the BION

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