PD20-03 PILOT STUDY EVALUATING SAFETY AND FEASIBILITY OF INTRAVESICAL INSTILLATION OF BOTULINUM TOXIN IN HYDROGEL-BASED SLOW RELEASE DELIVERY SYSTEM IN PBS/IC PATIENTS

Abstract

You have accessJournal of UrologyInfections/Inflammation of the Genitourinary Tract: Interstitial Cystitis1 Apr 2015PD20-03 PILOT STUDY EVALUATING SAFETY AND FEASIBILITY OF INTRAVESICAL INSTILLATION OF BOTULINUM TOXIN IN HYDROGEL-BASED SLOW RELEASE DELIVERY SYSTEM IN PBS/IC PATIENTS Kobi Stav, Yuri Vinshtok, Michal Jeshurun, Neely Ivgy-May, Tami Gerassi, and Amnon Zisman Kobi StavKobi Stav More articles by this author , Yuri VinshtokYuri Vinshtok More articles by this author , Michal JeshurunMichal Jeshurun More articles by this author , Neely Ivgy-MayNeely Ivgy-May More articles by this author , Tami GerassiTami Gerassi More articles by this author , and Amnon ZismanAmnon Zisman More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.674AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Intravesical instillation of botulinum toxin-A (BTX) is an appealing alternative to intradetrusor injection for treating painful bladder syndrome/interstitial cystitis (PBS/IC) but lacks a sustained effect due to a short exposure of urothelium to BTX. TCGel (TheraCoat Ltd) is a novel reverse-thermal gelation hydrogel allowing for instillations of liquid TCGel+BTX mixture into the bladder where it solidifies and BTX gradually releases for 6-8 hours. We investigated the feasibility and safety of intravesical instillation of BTX dissolved in TCGel preparation in patients with PBS/IC. METHODS A single intravesical instillation of 200U onabotulinumtoxin-A premixed with 40ml TCGel through 12Fr urethral catheter was delivered. Adverse events (AEs) and preliminary efficacy outcome measures were: bladder diary, Visual Analogue Scale (VAS), IC symptom and problem index (ICSI, ICPI). They were assessed at 2, 6 and 12 weeks following instillation. RESULTS 15 (M/F=4/11, age 24-76) severely symptomatic PBS/IC patients (ICSI range 12-19, ICPI range 12-16, median VAS=7) were enrolled. Safety: No increase in VAS score was noted at instillation. One severe AE was reported - an excisional biopsy of pre-existing sub-mandibular lymphadenopathy (benign histology). Three cases of mild constipation 24h to 3 weeks following instillation were noted as possibly drug-related AE's. Non-related AEs include post-instillation mild urogenital infection, flu and a case of worsening of bladder pain and depression symptoms at Week 12. Possible efficacy: Reduction in ICSI, ICPI and VAS was maintained throughout the follow-up period. Voiding frequency, nocturia and urge decreased up to Week 6 but returned to baseline level at Week12 (figure). CONCLUSIONS The results suggest that intravesical instillation of the novel TCGel+BTX is safe and tolerable. Preliminary results suggest sustained efficacy for weeks. A randomized controlled trial is warranted. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byTyagi P, Kashyap M, Yoshimura N, Chancellor M and Chermansky C (2016) Past, Present and Future of Chemodenervation with Botulinum Toxin in the Treatment of Overactive BladderJournal of Urology, VOL. 197, NO. 4, (982-990), Online publication date: 1-Apr-2017. Volume 193Issue 4SApril 2015Page: e398 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kobi Stav More articles by this author Yuri Vinshtok More articles by this author Michal Jeshurun More articles by this author Neely Ivgy-May More articles by this author Tami Gerassi More articles by this author Amnon Zisman More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...