Interstitial Cystitis Clinical Research Network (ICCRN)

Tufts Medical Center, Boston MA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The objectives of this proposal are the initiation and development of the Interstitial Cystitis Clinical Research Network (ICCRN) and the performance of randomized controlled multicenter clinical trials for the treatment of interstitial cystitis (IC). These 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 Committee consisting of the Clinical Centers, the Data Coordinating Center and the NIDDK Project Scientist. (b) recruitment and retention of patients who meet agreed upon Clinical Trials entry criteria The Specific Aims of the proposal are: (a) to assess the therapeutic effectiveness of drug (approved, investigational, other) and non-drug treatment of IC in well-characterized cohorts of IC patients (newly diagnosed, chronic, minority populations) (b) to utilize validated and meaningful treatment outcome measures (eg., SF-36 health-related quality of life; the O'Leary-Sant Symptom/Problem Index, global response assessment (GRA) (c) recruitment of a minimum of 50 patients/year for 4 years (total 200 patients). The Principal Investigator (Dr. Grannum R. Sant, has a 20 year experience in the diagnosis and treatment of IC and has a large IC patient population within his clinical practice. (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. (e) coordinate protocol development and clinical outcomes analyses with the Chronic Prostatitis Clinical Research Network (CPCRN) under the umbrella of the Urological Chronic Pain Syndromes Collaborative Network (UCPPSCG). The data obtained from these randomized controlled studies will define the effectiveness of various therapies for IC and improve the quality of life of patients suffering from IC. The collaboration with the UCPPSCG will better define the urological pelvic pain syndromes (male and female) and lead to better classification and treatment outcomes.