Introduction

Clinical trials are used to determine whether investigational new drugs or investigational treatments are both safe and effective. IC patients often choose to participate in studies because it may provide access to the latest investigational therapies and medications at no cost. Studies also allow the patient to interact with some of the best IC researchers in the country.

If you are considering participating in a trial, we suggest that you read the following resources:

• Are Clinical Studies For You?
• My Body On The Line: Take Me For Example.

Clinical Trial News

Interstitial Cystitis and Pain Study

(March 2008) Researchers at the University of Alabama at Birmingham are looking for women to participate in research studies concerning the mechanisms of pain in interstitial cystitis. If you are between the ages of 19 and 45 and if you have been diagnosed with Interstitial Cystitis for at least 6 months you might be an appropriate candidate for these research studies. Participants will be asked to record symptoms related to interstitial cystitis in a diary at home for 4 months. Women who are pregnant or had a hysterectomy are not eligible. For more information please contact our research office at 205-934-7703 or by email: womensresearch@ccc.uab.edu
(Support: NIH/NIDDK; Principal Investigator: Ursula Wesselmann MD, Dept. of Anesthesiology, University of Alabama at Birmingham)

The Brain and IC

(Jan 2008) Dr. Anthony J. Schaeffer (Northwestern University) is seeking participants for a small study titled "Brain Abnormalities in Urologic Pelvic Pain Syndrome (UPPS)." Funded by the NIH, patients will undergo a functional MRI, a variety of sensitivity testing (skin, wrists, lower abdoment) and computer testing to help determine if the brain plays a role in our pelvic pain. Patients must be able to visit the clinic in Chicago. For additional information, please contact:

Northwestern University Feinberg School of Medicine Department of Urology

D. Marko, RN at: (312) 695-3898  or by email at: d-marko@northwestern.edu

Federal IC Research Takes A Dramatic New Direction

(October 2007) Is IC/PBS just a bladder condition??? Is prostatitis just a prostate condition??? Why do IC patients struggle with irritable bowel syndrome? In a move which has many IC patients saying “It’s about time!,” the National Institutes of Health (NIH) has launched a new research network to help uncover the genetic, biological and behavioral relationships between these conditions.

This is a remarkable change of direction for the IC research movement. In past years, the NIH and other funding groups inexplicably “clung” the concept of IC as only a bladder disease despite significant new findings that showed that other conditions could be (and probably are) involved.

Many of the new discussions in the IC research movement are focusing on the concept of neuroinflammation and neurosensitization. It may be that once our body has sustained an injury, perhaps to any organ, it may create a cascade like effect of neurosensitization in nearby organs. IBS and IC, for example, both involve neurosensitization of the nerves in those organs and, in both cases, treatments are focused on reducing stimulation. This could explain why coffee, a well known neurostimulatory agent, exacerbates both IC and IBS. This new study will help determine the relationships, if any, between these conditions including the role of neurosensitization. The new Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network will receive up to $7.5 million dollars a year.

NIDDK Launches Physical Therapy Trial for Pelvic Pain

(May 2007) This new study will assess the effectiveness of physical therapy for the treatment of pelvic pain. Eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage. Read more!

Current Clinical Trials Listings

There are a few services on the web that provide listings of current trials. Clinicaltrials.gov, our favorite, is a service sponsored by the National Institutes of Health. Centerwatch.com is an industry sponsored listing service.

1. Genetics of Interstitial Cystitis
2. Sacral Neuromodulation in Patients With IC
3. An Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis.
4. Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder
5. Genetic Studies in Interstitial Cystitis
6. A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
7. A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil
8. Botox as a Treatment for Interstitial Cystitis in Women
9. Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms
10. Phase II Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
11. An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
12. Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
13. Women's Initiative for Pelvic Pain and Sexual Health (WISH) Program in the Department of Urology at Beaumont
14. Physical Therapy Trial for Pelvic Pain
15. Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
16. Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
    

Current NIDDK IC/PBS Research Centers

IC research is done at a wide variety of urology clinics. Many local and regional clinics participate in pharmaceutical company sponsored studies and/or may conduct their own research. Universities are the foundation for IC research not only for their access to excellent researchers but also large populations of patients who might participate. IC research centers which are funded by the National Institutes of Health (NIDDK) are often considered the best in the country.

Currently, there are two research networks, the ICCRN (IC research centers) and the CPCRN (prostatitis research centers) that are united under a single umbrella organization, the UPPCRN (Urologic Pelvic Pain Collaborative Research Network). The clinics and investigators below are current participates.

CALIFORNIA

Stanford University Medical Center (ICCRN) - Christopher Payne, M.D. & Rodney Anderson, M.D. Contact: Debra Clay, R.N. - Research Coordinator at (650) 724-1753

David Geffen School of Medicine at UCLA (CPCRN) - Mark S. Litwin, M.D., Scott Zeitlin, M.D., Nand S. Datta, M.D. Contact: Gwendolyn Byrd, MA, at (310) 267-2526

King-Drew Medical Center, Urology/Dept. of Surgery (CPCRN) - Dr. Nand Datta Contact: Kawajalen Mervin at 310-668-4545

ILLINOIS

Loyola University Medical Center (ICCRN) - Marypat Fitzgerald, M.D. & Linda Brubaker, M.D. Contact: Judith Senka, R.N. - Research Coordinator at (708) 216-8495

Northwestern University Feinberg School of Medicine (CPCRN) - Anthony J. Schaefer, M.D., Robert B. Nadler, M.D., J. Quentin Clemens, M.D. Contact: Darlene Marko RN, BSN, CCRC(312) 695-3898

IOWA

University of Iowa Hospitals and Clinic (ICCRN) - Karl Kreder, M.D. , Michael O’Donnell, M.D. Contact: Mary Eno, R.N. - Research Coordinator at (319) 384-9265 Kelley O’Berry - Recruitment Coordinator at (319) 384-5064

MARYLAND

University of Maryland (ICCRN) - Toby Chai, M.D., Susan Keay, M.D. Contact: Judith Murray, CCRC - Research Coordinator (410) 328-5784

MICHIGAN - Detroit

Henry Ford Hospital (ICCRN) - David Burks, M.D. Contact: Jill Sullivan, R.N., B.S.N. - Research Coordinator at (313) 916-3140 Michelle Peabody, R.N. - Research Coordinator at (313) 916-8265

William Beaumont Hospital (ICCRN) - Kenneth Peters, M.D. Contact: Eleanor Anton, R.N. - Research Coordinator at (248) 551-0885

MISSISSIPPI

The University of Mississippi Medical Center (CPCRN) - Paige White, M.D. Contact: (610) 984-5195

NEW YORK

University of Rochester Medical Center (ICCRN) - Robert Mayer, M.D. & Edward M. Messing, M.D. Contact: Elizabeth Smith, B.S. - Research Coordinator at (585) 275-0989 Kay Rust, R.N., M.S.N., F.N.P - Research Coordinator at (585) 275-0133

OHIO

Cleveland Clinic (CPCRN) - Daniel Shoskes, M.D., Contact: Donel Murphy (216) 445-7505

PENNSYLVANIA

Univ. of Pennsylvania (ICCRN) - Philip Hanno, M.D. Diane Newman, R.N.C., M.S.N., CRNP Contact: Lilliam Ribeiro, B.S. - Research Coordinator at (215) 615-3780

Temple University School of Medicine (CPCRN) - Michel A. Pontari, M.D., Contact: Melody Santiago, RN, (215) 707-3783

WASHINGTON

Univ. of Washington (ICCRN) - Richard E. Berger, M.D., Jane Miller, M.D. & Elizabeth A. Miller, M.D. Contact: Sharon Downing, R.N. - Research Coordinator at (206) 598-0850

University of Washington-Harborview Medical Center (CPCRN) - John N. Krieger, M.D., P.I., Robert Sweet, M.D., Co-PI & Susan O. Ross, R.N. Contact: Leslie Butler 206-616-7416

CANADA

Queen's University Kingston, Ontario, Canada (ICCRN) - J. Curtis Nickel, M.D., Contact: Joe Downey, M.Sc., CCRP, (613) 533-2894

MALAYSIA

University of Sciences Malaysia (CPCRN) - Liong Men Long, M.D., Contact: Shaun Lee Wen Huey, Research Coordinator, nuahsell@yahoo.com, Mobile: 012-2030508