MP33-02 PROSPECTIVE MULTICENTER DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF THE EFFICACY AND SAFETY OF LIPOSOMAL BOTULINUM TOXIN-A INSTILLATION VS. PLACEBO IN TREATMENT OF PATIENTS WITH REFRACTORY OVERACTIVE BLADDER (2014)

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence Therapy I1 Apr 2014MP33-02 PROSPECTIVE MULTICENTER DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF THE EFFICACY AND SAFETY OF LIPOSOMAL BOTULINUM TOXIN-A INSTILLATION VS. PLACEBO IN TREATMENT OF PATIENTS WITH REFRACTORY OVERACTIVE BLADDER Yao-Chi Chuang, Jonathan Kaufmann, David Chancellor, Michael Chancellor, and Hann-Chorng Kuo Yao-Chi ChuangYao-Chi Chuang More articles by this author , Jonathan KaufmannJonathan Kaufmann More articles by this author , David ChancellorDavid Chancellor More articles by this author , Michael ChancellorMichael Chancellor More articles by this author , and Hann-Chorng KuoHann-Chorng Kuo More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.953AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Intradetrusor injection of botulinum toxin has been shown to be effective for the treatment of refractory overactive bladder (OAB), however, the treatment requires a cystoscopic procedure with 20-30 needle injections and risk of urinary retention. We studied the safety and efficacy of a single instillation of liposomal OnabotulinumtoxinA (LP-09) 200 U solution. METHODS A two-center, double-blind, prospective, randomized, placebo-controlled, study enrolled male and female patients with idiopathic OAB who were inadequately managed by antimuscarinics. Subjects were randomized to either LP-09 or saline administered as 50 ml solution. The primary end point was mean change from baseline in the number of micturitions per day at 4 weeks post treatment. Additional end points included mean change of urgency and incontinence episodes, OAB symptom score (OABSS), and urgency severity score (USS). Safety assessments included adverse events and post void residual (PVR) urine volume. RESULTS Figure 1 illustrates the reduced urinary frequency associated with LP-09 treatment vs. placebo, as well as the lack of an associated increase in PVR. The treatment-associated frequency reduction (compared to that of the placebo) is statistically significant at 4-weeks (p<0.03). Similarly, the frequency of urgency events decreased with treatment. However, these improvements did not reach statistical significance with respect to the placebo group. The urgency severity score decreased for the treatment group as compared to the placebo group at 4-weeks (p<0.04). The results were inconclusive on the effect of treatment on urge incontinence episodes, since the sample population had a relatively low baseline incidence. CONCLUSIONS A single intravesical instillation of LP-09 decreased several OAB symptoms 4-weeks post treatment, and was well tolerated with a safety profile similar to placebo with no treatment-associated increase in PVR urine volume. Intravesical instillation of liposomal botulinum toxin may be a promising approach for treatment of refractory OAB without the need for cystoscopic needle injection and its associated risk of urinary retention. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e338 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Yao-Chi Chuang More articles by this author Jonathan Kaufmann More articles by this author David Chancellor More articles by this author Michael Chancellor More articles by this author Hann-Chorng Kuo More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...