A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Cystitis, Interstitial, Ulcer
About this trial
This is an interventional treatment trial for Cystitis, Interstitial
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
Exclusion Criteria:
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Sites / Locations
- Tri Valley Urology Medical Group
- Sutter Institute for Medical Research
- Women's Health Specialty Care
- Atlanta Medical Research Institute
- Anne Arundel Urology, P.A.
- Chesapeake Urology Research Associates
- Beyer Research
- Beaumont Health System
- Washington University School of Medicine Department of Surgery
- Western New York Urology Associates, LLC
- McKay Urology
- Eastern Urological Associates, PA
- Wake Forest Baptist Health
- MetroHealth System/Center for Advanced Gynecology
- Philadelphia Urosurgical Associates
- University of Washington
- Aurora Health Care
- Silverado Research Inc
- Sunnybrook Health Science Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.