LiRIS® 400 mg in Women with Interstitial Cystitis (IC) and Hunner's Lesion
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; Cystocopy with 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 original; Initiation of physical therapy within 4 weeks prior to screening; Current or planned use of electrostimyulatinoneuromodulation 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.