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Efficacy and Safety of Oxybutynin Chloride Topical Gel for Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled, Multicenter Study

2009; Lippincott Williams & Wilkins; Volume: 181; Issue: 4 Linguagem: Inglês

10.1016/j.juro.2008.11.125

1527-3792

David R. Staskin, Roger R. Dmochowski, Peter K. Sand, Scott MacDiarmid, Kim E. Caramelli, Heather Thomas, Gary Hoel,

Urinary Tract Infections Management

No AccessJournal of UrologyAdult Urology1 Apr 2009Efficacy and Safety of Oxybutynin Chloride Topical Gel for Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled, Multicenter Study David R. Staskin, Roger R. Dmochowski, Peter K. Sand, Scott A. MacDiarmid, Kim E. Caramelli, Heather Thomas, and Gary Hoel David R. StaskinDavid R. Staskin Caritas-St. Elizabeth's Medical Center, Tufts University Medical Center, Boston, Massachusetts , Roger R. DmochowskiRoger R. Dmochowski Vanderbilt Continence Center, Vanderbilt University School of Medicine, Nashville, Tennessee , Peter K. SandPeter K. Sand Evanston Continence Center, Evanston Northwestern Healthcare, Feinberg School of Medicine, Northwestern University, Evanston, Illinois , Scott A. MacDiarmidScott A. MacDiarmid Alliance Urology Specialists, Greensboro, North Carolina , Kim E. CaramelliKim E. Caramelli Watson Laboratories, Salt Lake City, Utah , Heather ThomasHeather Thomas Watson Laboratories, Salt Lake City, Utah , and Gary HoelGary Hoel Watson Laboratories, Salt Lake City, Utah View All Author Informationhttps://doi.org/10.1016/j.juro.2008.11.125AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We assessed the efficacy and safety of oxybutynin chloride topical gel vs placebo in adults with overactive bladder. Materials and Methods: Men and women 18 years or older with urge predominant urinary incontinence were enrolled in randomized, parallel group, double-blind, placebo controlled Study OG05009 done at 76 clinics in the United States. Eligible patients were assigned to receive 1 gm oxybutynin chloride topical gel (10% weight per weight ethanol based formulation of oxybutynin) or matching placebo once daily for 12 weeks. Efficacy was assessed using data from 3-day urinary diaries and the primary outcome was the change from baseline in the number of urge incontinence episodes. Safety was monitored through adverse event reporting. Efficacy results in the oxybutynin chloride topical gel and placebo groups were compared by ANCOVA with last observations carried forward. Results: A total of 789 randomized patients, including 704 women (89.2%), with a mean age of 59 years were assigned to treatment with oxybutynin chloride topical gel (389) or placebo (400). The mean number of urge incontinence episodes decreased significantly more in patients treated with oxybutynin chloride topical gel than in those given placebo (−3.0 vs −2.5 per day, p <0.0001). Mean urinary frequency decreased (−2.7 per day, p = 0.0017) and voided volume increased (21.0 ml, p = 0.0018) significantly more in the oxybutynin chloride group than in the placebo group (−2.0 per day and 3.8 ml, respectively). Treatment related dry mouth was more frequent in the oxybutynin chloride group than in the placebo group (27 of 389 patients or 6.9% vs 11 of 400 or 2.8%). Application site reactions were infrequently observed in the oxybutynin chloride and placebo groups (21 of 389 patients or 5.4% and 4 of 400 or 1.0%, respectively). No serious treatment related adverse events occurred. Conclusions: Oxybutynin chloride topical gel was efficacious in improving overactive bladder symptoms and was well tolerated in adult patients. References 1 : The standardisation of terminology in lower urinary tract function: report from the Standardization Sub-Committee of the International Continence Society. Urology2003; 61: 37. Google Scholar 2 : Prevalence and burden of overactive bladder in the United States. World J Urol2003; 20: 327. 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Google Scholar © 2009 by American Urological AssociationFiguresReferencesRelatedDetailsCited byGittelman M, Weiss H and Seidman L (2018) A Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Oxybutynin Vaginal Ring for Alleviation of Overactive Bladder Symptoms in WomenJournal of Urology, VOL. 191, NO. 4, (1014-1021), Online publication date: 1-Apr-2014. Volume 181Issue 4April 2009Page: 1764-1772 Advertisement Copyright & Permissions© 2009 by American Urological AssociationKeywordsanticholinergicoveractive bladdertransdermaloxybutyninurinary incontinenceAcknowledgmentsLaboratory assessments were performed at Mayo Laboratory for Clinical Trials, Rochester, Minnesota. Editorial assistance was provided by Scientific Connexions, Newtown, Pennsylvania.MetricsAuthor Information David R. Staskin Caritas-St. Elizabeth's Medical Center, Tufts University Medical Center, Boston, Massachusetts Financial relationship and/or other relationship with Allergan, Astellas, Pfizer and Watson. More articles by this author Roger R. Dmochowski Vanderbilt Continence Center, Vanderbilt University School of Medicine, Nashville, Tennessee Financial relationship and/or other relationship with Allergan, Novartis, Pfizer, Astellas and Watson. More articles by this author Peter K. Sand Evanston Continence Center, Evanston Northwestern Healthcare, Feinberg School of Medicine, Northwestern University, Evanston, Illinois Financial relationship and/or other relationship with Allergan, Astellas/GlaxoSmithKline, Pfizer, Watson and Sanofi-Aventis. More articles by this author Scott A. MacDiarmid Alliance Urology Specialists, Greensboro, North Carolina Financial relationship and/or other relationship with Allergan, Astellas, Pfizer and Watson. More articles by this author Kim E. Caramelli Watson Laboratories, Salt Lake City, Utah Financial relationship and/or other relationship with Watson Laboratories. More articles by this author Heather Thomas Watson Laboratories, Salt Lake City, Utah Financial relationship and/or other relationship with Watson Laboratories. More articles by this author Gary Hoel Watson Laboratories, Salt Lake City, Utah Financial relationship and/or other relationship with Watson Laboratories. More articles by this author Expand All Advertisement PDF downloadLoading ...