I am pleased to announce that we have a new NIH sponsored clinical trial for men and women with interstitial cystitis/painful bladder syndrome. The purpose is to study the effectiveness, side effects and mechanism of action of the oral drug cyclosporine in patients with IC/PBS who have failed at least 2 prior types of therapy and have persistent symptoms. It is an “open label” study and as such, all patients will receive the medication (at no charge). While Cyclosporine is not FDA approved for the treated of IC/PBS, it is a recommended option in the current treatment guidelines of the American Urological Association.
Brief Summary:
Patients: symptomatic IC/PBS who have failed at least 2 classes of treatment (eg. Elmiron and Elavil or Interstim and Physical Therapy). Exclusion criteria include kidney disease, current use of opiod narcotics, diabetes and cancer (there are others). A cystoscopy within the past year must show no other bladder pathology
Intervention: treatment for 3 months with Cyclosporine. Patients are allowed to stay on their current therapies as long as they are still sufficiently symptomatic while on them.
Testing: bloodwork, nuclear scan test of kidney function, urine tests and neurologic testing with a Neurometer device that measures skin sensation and pain perception. These tests are done before, during and after treatment with Cyclosporine.
This study is only being conducted at the main campus of the Cleveland Clinic in Cleveland Ohio
If interested, for more information please call 216-445-4757
New NIH Study for Interstitial Cystitis
- dshoskes
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New NIH Study for Interstitial Cystitis
Daniel Shoskes MD
www.dshoskes.com
www.dshoskes.com
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Re: New NIH Study for Interstitial Cystitis
Dr. Shoskes,
Cyclosporine seems to be a rather strange selection for treatment. I know of a very small study on it by a group in Oklahoma, they all had their symptoms return after use. Surely, a patient couldn't stay on it indefinitely although if you subscribe to the theory that if you can allow your brain to "forget" the pain it may be a home run and not return.
If you have the time could you give the brief theory behind using it. I struggle with the auto-immune disease idea.
Cyclosporine seems to be a rather strange selection for treatment. I know of a very small study on it by a group in Oklahoma, they all had their symptoms return after use. Surely, a patient couldn't stay on it indefinitely although if you subscribe to the theory that if you can allow your brain to "forget" the pain it may be a home run and not return.
If you have the time could you give the brief theory behind using it. I struggle with the auto-immune disease idea.
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- dshoskes
- Urologist
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Re: New NIH Study for Interstitial Cystitis
There have been several studies in Europe including randomized placebo controlled trials. Cyclosporine has many effects other than immunosuppression and one of the goals of this research is to better understand the mechanism.
Daniel Shoskes MD
www.dshoskes.com
www.dshoskes.com
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Re: New NIH Study for Interstitial Cystitis
Hi Dr. Shoskes. I was a patient of yours in early 2013. You performed multiple tests that showed no problems with my urethra, prostate, but did notice a small abnormality in my bladder.
Since then I have been seeing Dr. Kenneth Peters and we have been taking the pudendal neuralgia approach. I've had 3 injections into my Alcock's canal and one to my coccyx with minimal success. I have been in PT for almost a year and do yoga on a regular basis.
At this point I think I have tried most approaches with minimal improvement. Would I be a possible candidate for this Study?
David Aschenbach
Since then I have been seeing Dr. Kenneth Peters and we have been taking the pudendal neuralgia approach. I've had 3 injections into my Alcock's canal and one to my coccyx with minimal success. I have been in PT for almost a year and do yoga on a regular basis.
At this point I think I have tried most approaches with minimal improvement. Would I be a possible candidate for this Study?
David Aschenbach
- dshoskes
- Urologist
- Posts: 204
- Joined: Wed Oct 30, 2002 7:51 pm
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Re: New NIH Study for Interstitial Cystitis
Sorry, I am out of town and unable to access your medical record to answer your question until Jan 3. Just to be clear, we would have had to make an actual clinical diagnosis of interstitial cystitis for you to be eligible for the study.Richard1969 wrote:Hi Dr. Shoskes. I was a patient of yours in early 2013. You performed multiple tests that showed no problems with my urethra, prostate, but did notice a small abnormality in my bladder.
Since then I have been seeing Dr. Kenneth Peters and we have been taking the pudendal neuralgia approach. I've had 3 injections into my Alcock's canal and one to my coccyx with minimal success. I have been in PT for almost a year and do yoga on a regular basis.
At this point I think I have tried most approaches with minimal improvement. Would I be a possible candidate for this Study?
David Aschenbach
Daniel Shoskes MD
www.dshoskes.com
www.dshoskes.com
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Re: New NIH Study for Interstitial Cystitis
Hi Dr. Shoskes-
Were you able to review my medical records?
-David Aschenbach
Were you able to review my medical records?
-David Aschenbach
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Re: New NIH Study for Interstitial Cystitis
Please contact Dr Shoskes directly about confidential doctor-patient issues. There is an email link at his site: http://www.dshoskes.com/
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