TARIS Biomedical® has initiated a second Phase 2 study investigating LiRIS in women with Interstitial Cystitis. LiRIS is designed to continuously provide lidocaine over an extended period in the bladder. You may be able to participate! The study is currently active at 13 study centers across the United States and one in Canada, and will ultimately include up of 20 study centers in the US and Canada.
Patients who qualify and choose to participate will have the option to receive the system with lidocaine, as described as below. The study is being conducted in two parts. In the first portion, patients who qualify and choose to participate will be randomly assigned to be treated with either the active LiRIS system or a placebo system (1:1 assignment). If they qualify, patients completing this portion of the study can continue to the second part of the study, in which all participants will receive the active LiRIS system.
LiRIS is an investigational product which combines the local anesthetic lidocaine with a small, flexible delivery device. LiRIS is inserted into the bladder via a cystoscope, and remains in the bladder for 14 days where it is designed to continuously deliver lidocaine. At the end of this period, LiRIS is removed via a second cystoscopic procedure. Study participants will need to go to the clinic for study visits and assessments, and will complete questionnaires, including a voiding frequency diary, both at home during the study and during a 4 week follow-up period thereafter.