LiRIS® Research Study in IC Patients with Hunner’s Ulcers & Lesions
Posted Oct 17 2013 5:07pm
This is the first of two clinical trial announcements released by the ICN today, both featuring clinical trials for interstitial cystitis. This first study is evaluating the use of LiRIS in the treatment of Hunner’s lesions, aka ulcers. Early LiRIS pain studies found that some Hunner’s ulcers were responding to treatment, a result we have not seen with any other treatment. If successful, this new study could pave the way for a new, much needed therapy for the most severe form of IC. If you have struggled with bladder lesions or ulcers and are able to visit this research site (Royal OK, MI), I think this study is worth learning more about. – Jill Osborne MA – ICN President
TARIS Biomedical® has initiated an open label Phase 1b research study investigating LiRIS in women with Interstitial Cystitis (IC) with a history of Hunner’s lesions in the bladder. The study is currently being conducted in Michigan, and may include up to 3 centers in the United States.
LiRIS is an investigational product (not approved by FDA) that combines the local anesthetic lidocaine with a small, flexible delivery device. LiRIS is designed to continuously provide lidocaine to the bladder over an extended period. LiRIS is inserted into the bladder via a cystoscope and remains in the bladder for 14 days. At the end of the 14-day 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 be asked to complete questionnaires, including a voiding frequency diary, both at home during the study and throughout a follow-up period thereafter.
You may be eligible if you:
Have been diagnosed with IC with a history of Hunner’s lesions in the bladder
Experience pain and voiding symptoms associated with your IC
Are able and willing to complete the questionnaires and voiding frequency diary
Can comply with the full visit schedule and all associated procedures
For More Details:
Please go to clinicaltrials.gov for more information and site locations near you. Use trial identifier NCT01879683.
Contact: Maureen Cooney, RN, William Beaumont Hospital – Department of Urology Research at 248-551-3355