A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
Cystitis, Interstitial, Painful Bladder Syndrome
About this trial
This is an interventional treatment trial for Cystitis, Interstitial
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of interstitial cystitis or bladder pain syndrome
Exclusion Criteria:
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
- Previous treatment with LiRIS®
Sites / Locations
- Coastal Clinical Research, Inc.
- IC Study LLC
- Tower Urology
- Tri Valley Urology Medical Group
- Genesis Research LLC
- Sutter Health
- Women's Health Specialty Care
- Yale University
- Manatee Medical Research Institute
- Atlanta Medical Research Instititute
- Idaho Urologic Institute
- Associated Surgeons and Physicians LLC DBA Women's Health Advantage
- Regional Urology, LLC
- Anne Arundel Urology, P.A.
- Chesapeake Urology Research Associates
- Beyer Research
- William Beaumont Hospital
- Washington University
- Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
- Cooper University Hospita/ Univeristy Urogynecology Associates
- Western New York Urology Associates
- BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
- Urology Institute of Long Island
- McKay Urology
- Alliance Urology Specialist, P.A.
- Eastern Urological Associates, PA
- Wake Forest University
- MetroHealth System
- Female Sexual and Pelvic Health Institute
- Integrity Medical Research (Urology Northwest)
- University of Washington
- Silverado Research Inc
- Urology Associates/Urologic Medical Research
- Sunnybrook Health Science Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Other
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.