565 PHASE 3 EFFICACY AND SAFETY OF ONCE-MONTHLY OXYBUTYNIN VAGINAL RING DELIVERING 4 MG/DAY OR 6 MG/DAY VS PLACEBO RING IN WOMEN WITH URGE INCONTINENCE, FREQUENCY, AND URGENCY SYMPTOMS OF OVERACTIVE BLADDER

Abstract

You have accessJournal of UrologyUrodynmaics/Incontinence/Female Urology: Incontinence, Evaluation & Therapy (I)1 Apr 2013565 PHASE 3 EFFICACY AND SAFETY OF ONCE-MONTHLY OXYBUTYNIN VAGINAL RING DELIVERING 4 MG/DAY OR 6 MG/DAY VS PLACEBO RING IN WOMEN WITH URGE INCONTINENCE, FREQUENCY, AND URGENCY SYMPTOMS OF OVERACTIVE BLADDER Mark Swierzewski, Larry Seidman, Sue Dasen, and Herman Weiss Mark SwierzewskiMark Swierzewski Tampa, FL More articles by this author , Larry SeidmanLarry Seidman Philadelphia, PA More articles by this author , Sue DasenSue Dasen Frazer, PA More articles by this author , and Herman WeissHerman Weiss Petach Tikva, Israel More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.1961AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Oxybutynin vaginal ring (OxyVR) is a novel delivery system developed to bypass hepatic metabolism and improve tolerability over oral antimuscarinic agents used to treat overactive bladder (OAB). Our objective was to compare the efficacy and safety of OxyVR delivering 4 or 6 mg/day to placebo vaginal ring (PVR) in women with precisely defined OAB symptoms. METHODS In this randomized, double-blind, multicenter, 12-week (W) trial (NCT00685113), women with pure/predominantly urge incontinence were consented and randomized to OxyVR4, OxyVR6 or PVR. A new vaginal ring (VR) was inserted every 4W. Women whose 3-day screening diaries met all 3 OAB-defining criteria comprised the analysis population: ≥5 urge incontinence episodes (IEs)/W; average daily urinary frequency (UFreq) ≥8 voids/24h; average void volume (VV) ≤3L/24h. Women inserting ≥1VR were evaluated for safety. Efficacy was assessed by comparing changes from baseline in total (stress +urge) IEs/W (primary endpoint), UFreq, VV and percent with no IEs in a final 3-day diary. RESULTS A total of 1102 women (362 randomized to OxyVR4, 369 to Oxy VR6, 371 to PVR) comprised the safety population; 882 (295, 278, 309, respectively) met all 3 OAB criteria. Groups had similar baseline demographic and OAB characteristics; 94% completed 12W. From baseline to 12W, OxyVR4 and OxyVR6 treatment resulted in statistically significant improvements compared to PVR in weekly IEs and daily UFreq, with no significant differences in VV (Table 1). In the final 3-day diary, 36% of OxyVR4 (P=0.029), 35% of OxyVR6 (P=0.074) vs 28% of PVR-treated women had no IEs. In the safety population, both OxyVR doses were well tolerated, with no serious adverse events (AEs) attributable to treatment. Dry mouth occurred in 6% (OxyVR4) and 8% (OxyVR6) vs 4% (PVR), constipation in 1%, 1% vs 2%, culture-positive urinary tract infections in 8%, 10% vs 8%, respectively. Few withdrew due to AEs (3.6%, 6.8% vs 3.0%, respectively), only 0.2% for dry mouth. Other vaginal complaints reported in 1.9%-5.9% of women overall were distributed equally across groups. CONCLUSIONS OxyVR offers women a once-monthly, effective, safe, and well tolerated treatment option for OAB. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e232 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mark Swierzewski Tampa, FL More articles by this author Larry Seidman Philadelphia, PA More articles by this author Sue Dasen Frazer, PA More articles by this author Herman Weiss Petach Tikva, Israel More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...