A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
- Conditions
- Painful Bladder SyndromeCystitis, Interstitial
- Interventions
- Combination Product: LiRIS®Combination Product: LiRIS Placebo
- Registration Number
- NCT02411110
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 131
- Diagnosis of interstitial cystitis or bladder pain syndrome
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
- Previous treatment with LiRIS®
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS® 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. LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS® 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. LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS Placebo 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up Baseline (Days -7 to 0) to Treatment 1 Week 4 The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: \< 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors was used for analysis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Women's Health Specialty Care
🇺🇸Farmington, Connecticut, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
IC Study LLC
🇺🇸Escondido, California, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Manatee Medical Research Institute
🇺🇸Bradenton, Florida, United States
Sutter Health
🇺🇸Vacaville, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Associated Surgeons and Physicians LLC DBA Women's Health Advantage
🇺🇸Fort Wayne, Indiana, United States
Atlanta Medical Research Instititute
🇺🇸Alpharetta, Georgia, United States
Anne Arundel Urology, P.A.
🇺🇸Annapolis, Maryland, United States
Chesapeake Urology Research Associates
🇺🇸Baltimore, Maryland, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
🇺🇸Saint Louis, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Western New York Urology Associates
🇺🇸Cheektowaga, New York, United States
Cooper University Hospita/ Univeristy Urogynecology Associates
🇺🇸Voorhees, New Jersey, United States
BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
🇺🇸Lake Success, New York, United States
Urology Institute of Long Island
🇺🇸Plainview, New York, United States
McKay Urology
🇺🇸Charlotte, North Carolina, United States
Alliance Urology Specialist, P.A.
🇺🇸Greensboro, North Carolina, United States
Eastern Urological Associates, PA
🇺🇸Greenville, North Carolina, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Washington
🇺🇸Seattle, Washington, United States
Integrity Medical Research (Urology Northwest)
🇺🇸Mountlake Terrace, Washington, United States
Female Sexual and Pelvic Health Institute
🇺🇸Philadelphia, Pennsylvania, United States
Urology Associates/Urologic Medical Research
🇨🇦Kitchener, Ontario, Canada
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
Silverado Research Inc
🇨🇦Victoria, British Columbia, Canada
Genesis Research LLC
🇺🇸San Diego, California, United States
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada