You have accessJournal of UrologyInfections/Inflammation/Cystic Disease of the Genitourinary Tract: Interstitial Cystitis1 Apr 2016MP72-16 SAFETY, TOLERABILITY, AND PRELIMINARY EFFICACY OF LIRIS® 400 MG IN WOMEN WITH ULCERATIVE INTERSTITIAL CYSTITIS Kenneth Peters, Yodit Seifu, Chris Cutie, and Daniel Radecki Kenneth PetersKenneth Peters More articles by this author , Yodit SeifuYodit Seifu More articles by this author , Chris CutieChris Cutie More articles by this author , and Daniel RadeckiDaniel Radecki More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1629AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Ulcerative interstitial cystitis (IC) is an inflammatory bladder condition with characteristic lesions (Hunner′s lesions) noted on cystoscopy that are associated with bladder pain and voiding frequency. LiRIS is a passive, nonresorbable, intravesical system designed to provide continuous, controlled release of lidocaine into the bladder over a 2-week period. METHODS This 2-center, open-label, Phase 1b study in women ≥18 y evaluated the safety, tolerability, and preliminary efficacy of LiRIS 400 mg over two 14-day treatment periods and up to 12-weeks follow-up (Day 112). Inclusion criteria included a pain Numeric Rating Scale (NRS) score of 3-9.5, ≥1 Hunner′s lesion at screening cystoscopy, and ≥8 daily voids. A second LiRIS 400 mg was inserted at Day 14 if Hunner′s lesions appeared improved or unchanged on Day 14; it was removed on Day 28. Treatment-emergent adverse events (TEAEs), pain, voiding frequency, and O′Leary-Sant Interstitial Cystitis Symptom Index (ICSI)/Interstitial Cystitis Problem Index (ICPI) scores were recorded. RESULTS Ten patients were enrolled (mean age 57.2 y). Three patients were excluded from the analysis: 1 had only 1 LiRIS treatment, 1 expelled LiRIS prior to Day 28, and 1 did not complete follow-up. The per-protocol population thus comprised 7 patients. By Days 14 and 28, 6/7 patients (86%) and 7/7 patients (100%), respectively, responded to treatment with decreased Hunner′s lesion affected area, lesion number, and/or lesion severity. Pain NRS scores were 5.5 at baseline (BL) and decreased significantly at all time points (P<.05), including 12 weeks following LiRIS removal; decreases from BL on Days 14, 28, and 112 were -2.97 (P=.004), -4.27 (P=.003), and -4.4 (P=.029), respectively. Mean daily voids were 18.2 at BL and were reduced significantly from Day 7 through Day 56, except on Day 14 (P=.055). ICSI/ICPI scores were similarly reduced from BL at Day 20 through at least Day 56 (P<.05). No patient discontinued due to TEAEs. TEAEs occurred in 6/10 patients (2 procedure-related, 2 device-constituent-related, 1 dysuria, 1 pollakiuria). CONCLUSIONS This small proof of concept study of LiRIS 400 mg in women with ulcerative IC and Hunner′s lesions demonstrated a favorable safety profile as well as long-lasting improvements in lesions, pain, voiding frequency, and ICSI/ICPI scores. Additional double-blind, placebo-controlled studies will be necessary to confirm the safety and effectiveness of LiRIS in larger numbers of patients. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e958 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Kenneth Peters More articles by this author Yodit Seifu More articles by this author Chris Cutie More articles by this author Daniel Radecki More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...