of the application) The primary objectives of this proposal are the initiation of an Interstitial Cystitis (IC) Trials Group and the performance of randomized, controlled multi-center studies therapies for IC utilizing validated treatment outcomes measures. The objectives will be achieved by: a) development and design of medical treatment protocols for IC and a manual of operations in conjunction with a Steering and Planning Committee consisting of the Clinical Centers, the Data Coordinating Center and the NIDDK Project Scientist. b) recruitment and retention of patients who meet the agreed upon Clinical Trials entry criteria.
The specific aims of the proposal are: a) to assess the therapeutic effectiveness of drugs (approved, investigational, other) and non-drug treatment of IC in well-characterized cohorts of IC patients; (b) to utilize validated and meaningful treatment outcome measures (e.g., SF-36 health-relate quality of life; the IC Symptom/Problem Index);c) recruitment of a minimum of 50 patients/year for 4 years (total 200 patients). The Principal Investigator (Dr. Grannum R. Sant, Tufts University School of Medicine) and Co-investigator (Dr. Edward Messing, University of Rochester), both have >10 years experience in the diagnosis and treatment of IC and have large patient populations within their clinical practices; d) there will be an initial 12 month period of collaborative protocol/manual of operations development, followed by 48 months of patient recruitment with concurrent data analysis and reporting. The data obtained from these randomized controlled studies will define the effectivenes of various therapies for IC and improve the quality of life of patients suffering from IC.
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