INTERSTITIAL CYSTITIS PHASE II TRIALS
Interstitial cystitis is a disease, which may affect over a million residents of the United States. To date there is no known cure for interstitial cystitis and most treatments are palliative at best. The NIDDK Interstitial Cystitis Data Base project began accruing patients in 1993 and provided invaluable information as it relates to the natural history, symptom association with urodynamic findings, cystoscopic findings and demographic information. This information and data is in place and has set the ground work for the next step of developing clinical research centers to carry out evaluation of therapies for IC in a prospective randomized fashion. The OU Health Sciences Center commits all of its resources, both on its campus in Oklahoma City and its network of outreach clinics throughout rural Oklahoma to recruit 200 patients into clinical trials. These protocols will be devised and written by the Steering Committee. Because of the sexual preponderance of IC being greater than 10:1, a collaborative effort has been arranged with the Department of Gynecology to access referrals from them for recruitment to these clinical trials. The University of Oklahoma has been interested in the treatment, diagnosis and management of IC for over 15 years. The Department of Urology ha also participated in the ICDB study project since its inception. In continuation of these research interests, we are submitting two concept sheets to the Steering Committee for their consideration for clinical research trials The newest treatment for IC, which has received FDA approval is the use of pentosulfate (Elmiron). Although this has shown reported successes of 50-75% i some individuals, there has been a significantly delayed time to response. Another form of therapy is behavior modification or Abladder retraining." Usin biofeedback offers the opportunity for pelvic floor musculature relaxation, which can alleviate the pain associated with bladder distention and IC. This adjuvant therapy of biofeedback with Elmiron may provide earlier time to response and offer significant palliation of IC symptoms while the oral epithelial coating agent, i.e. pentosulfate, is taking effect. The second concept is a two armed study using intravesical heparin versus intravesical heparin plus a biweekly, 6 week course of biofeedback bladder training for behavior modification. Patients in both arms of the study will be monitored fo positive response for one year. Eligibility will be determined by the Steering Committee. Positive response will be determined as greater to or equal to 40% improvement in clinical symptoms. To evaluate the durability of the response, participants will be reevaluated with the same tools every other month either by personal visit or telephone follow up. Statistical considerations for the pilot study will be determined by the steering committee.