Interstilal Cystitis Clinical Research Network

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DESCRIPTION (provided by applicant): Interstitial cystitis (IC) is a condition that remains enigmatic both in diagnosis and treatment. Characteristic symptoms include chronic pelvic pain, urinary urgency, and urinary frequency. While these symptoms seem specific, in fact, they can vary widely, especially the description of the pain (nature, location, chronicity, flares). For most clinicians, chronic pelvic pain is the symptom-complex most difficult to treat effectively. Because the etiology(s) for IC is (are) unknown, treatment has been entirely empiric. For the last 5 years, we at the University of Maryland have participated in the Interstitial Cystitis Clinical Trials Group (ICCTG) in hopes of scientifically validating certain treatments used for IC as well as studying potential new agents. Two randomized trials were completed during this time. The lessons learned from the ICCTG translate into specific aims for the proposed upcoming ICCRN trials. 1. There needs to be a new "definition" for IC rather than the current NIDDK-criteria established in 1987. The old criteria are too restrictive and no peer-reviewed objective diagnostic criteria are included. 2. Treatment outcomes of IC must be correlated with changes in objective parameters other than symptom scores and voiding diaries. 3. Enrollment of newly diagnosed IC patients must be maximized in the upcoming trials. Studying newly diagnosed IC patients may shed some light as to the natural history as well as response to treatment in this specific population. To this end, we are collaborating with private practice urologists who primarily see early IC patients and should help provide adequate enrollment of these types of patients into clinical trials. The trial that we propose to conduct is botulinum toxin-A (BTX-A) bladder injections. Recent data suggest that BTX-A has an anti-sensory action in the bladder. The group of investigators participating in this grant represent leaders in IC research. They have experience in recruiting IC patients into clinical trials, performing translational and basic science IC research. The continued advancement in diagnosis and treatment of IC depend on this type of collaboration in a multi-disciplinary environment such as that which exists at University of Maryland. The goals of the University of Maryland clinical site are to maximize enrollment of IC patients into innovative clinical trials, maintain highest retention rates possible and acquire high quality data.