This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
131
LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.
LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy.
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
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.
Time frame: Baseline (Days -7 to 0) to Treatment 1 Week 4
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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
Genesis Research LLC
San Diego, California, United States
Sutter Health
Vacaville, California, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Manatee Medical Research Institute
Bradenton, Florida, United States
Atlanta Medical Research Instititute
Alpharetta, Georgia, United States
...and 24 more locations