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A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg
This research study is to determine the effectiveness and safety of a new "investigational" product called LiRIS® 400 mg. The investigational product (IP) is pretzel shaped. It is made of medical grade silicone and contains a wire to maintain the pretzel shape in the bladder and will be compared with a placebo that is of the same construction but does not contain any drug. The IP will be placed in the bladder for 28 days. The study will consist of a screening period.
Who may be Eligible
Inclusion: Female greater than 18 years of age with a diagnosis of IC with Hunner's Lesions; Mean daily average of pain between 4 and 9.5 on 0-10 NRS pain score; Daily average micturition frequency greater than 8 episodes. Exclusion: Patient who is pregnant, nursing or planning a pregnancy or unwilling to use reliable contraception/abstinence during the study; Cytoscopy within 4 weeks of the screening period. History of cardiovascular conditions including cardiac arrest, clinically significant arrhythmia or bradycardia; Evidence of urethral obstruction or stricture; Current pelvic pain of extravesicle originl; Initiation of physical therapy within 4 weeks prior to screening; Current or planned use of electrostimulation/neuromodulation device; History of any other diagnosis that may account for the symptoms of IC; More than 3 urogenital bacteria or viral infections in the last 12 months; Treatment with botulinum toxin therapy within 9 months of screening; Participation in a clinical study or treatment with IP within 4 weeks prior to screening; Previous exposure to LiRIS in a TARIS clinical study; Evidence of Hunner's Lesions on previous cystoscopy.