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Efficacy and Safety of Transdermal Oxybutynin in Patients With Urge and Mixed Urinary Incontinence

2002; Lippincott Williams & Wilkins; Volume: 168; Issue: 2 Linguagem: Inglês

10.1016/s0022-5347(05)64684-8

1527-3792

Roger R. Dmochowski, G. Willy Davila, Norman R. Zinner, Marc Gittelman, Daniel R. Saltzstein, Sydney Lyttle, Steven W. Sanders,

Urinary Bladder and Prostate Research

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 Aug 2002Efficacy and Safety of Transdermal Oxybutynin in Patients With Urge and Mixed Urinary Incontinence Roger R. Dmochowski, G. Willy Davila, Norman R. Zinner, Marc C. Gittelman, Daniel R. Saltzstein, Sydney Lyttle, Steven W. Sanders, and for THE TRANSDERMAL OXYBUTYNIN STUDY GROUP* Roger R. DmochowskiRoger R. Dmochowski More articles by this author , G. Willy DavilaG. Willy Davila More articles by this author , Norman R. ZinnerNorman R. Zinner More articles by this author , Marc C. GittelmanMarc C. Gittelman More articles by this author , Daniel R. SaltzsteinDaniel R. Saltzstein More articles by this author , Sydney LyttleSydney Lyttle More articles by this author , Steven W. SandersSteven W. Sanders More articles by this author , and for THE TRANSDERMAL OXYBUTYNIN STUDY GROUP* Participants: Philip Aliotta, Williamsville, New York; Ronald Anderson, Tacoma, Washington; Joseph Antoci, Waterbury, Connecticut; Stephen Auerbach, Newport Beach, California; Teresa Beam, Indianapolis, Indiana; C. Brito, Phoenix, Arizona; Grady Bruce, Austin, Texas; Jim Christensen, Las Vegas, Nevada; G. Davila, Fort Lauderdale, Florida; Bradley Davis, Overland Park, Kansas; Roger Dmochowski, Fort Worth, Texas; Brian Feagins, Dallas, Texas; Roger Fincher, Spokane, Washington; Jeffery Frankel, Seattle, Washington; Marc Gittelman, Aventura, Florida; Lee Harbach, San Diego, California; Richard Harris, Melrose, Illinois; Terence Isakov, Lyndhurst, Ohio; Michael Kaempf, Portland, Oregon; Joel Kaufman, Aurora, Colorado; Ira Klimberg, Ocala, Florida; Dean Knoll, Nashville, Tennessee; R. Michael Kroeger, Omaha, Nebraska; Stuart Liberman, Melbourne, Florida; Murray Lieberman, Rockville, Maryland; Joel Lilly, Seattle, Washington; Edward Loizides, Bayshore, New York; James Mcmurray, Huntsville, Alabama; Myron Murdock, Greenbelt, Maryland; Diane Normandin, Clearwater, Florida; Steven Rosenberg, Des Moines, Iowa; Daniel Saltzstein, San Antonio, Texas; Paul Sieber, Lancaster, Pennsylvania; James Simon, Laurel, Maryland; Jeffrey Snyder, Denver, Colorado; Sammy Vick, San Antonio, Texas; W. Wells, Birmingham, Alabama; Mitchell Wiatrak, Milwaukee, Wisconsin; Jay Young, Laguna Woods, California; and Norman Zinner, Torrance, California. More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)64684-8AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We evaluated the efficacy and safety of an oxybutynin transdermal delivery system (TDS) in a general population of patients with overactive bladder and urge or mixed urinary incontinence. Materials and Methods: Following symptom stabilization or treatment withdrawal 520 adult patients were randomized to 12 weeks of double-blind daily treatment with 1.3, 2.6 or 3.9 mg. oxybutynin TDS or placebo administered twice weekly, followed by a 12-week open-label, dose titration period to assess efficacy and safety further. Evaluations included patient urinary diaries, incontinence specific quality of life and safety. Results: A dose of 3.9 mg. daily oxybutynin TDS significantly reduced the number of weekly incontinence episodes (median change −19.0 versus −14.5, p = 0.0165), reduced average daily urinary frequency (mean change −2.3 versus −1.7, p = 0.0457), increased average voided volume (median change 24 versus 6 ml., p = 0.0063) and significantly improved quality of life (Incontinence Impact Questionnaire total score, p = 0.0327) compared with placebo. Average voided volume increased in the daily 2.6 mg. group (19 ml., p = 0.0157) but there were no other significant differences between 1.3 and 2.6 mg. oxybutynin TDS and placebo. The most common adverse event was application site pruritus (oxybutynin TDS 10.8% to 16.8%, placebo 6.1%). Dry mouth incidence was similar in both groups (7.0% versus 8.3%, p not significant). In the open-label period a sustained reduction of nearly 3 incontinence episodes per day was reported for all groups. 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Google Scholar From Urology Associates of North Texas, Fort Worth, Urology San Antonio Research, San Antonio and PPD Development, Inc., Austin, Texas, Cleveland Clinic Florida, Fort Lauderdale and South Florida Medical Research, Aventura, Florida, Doctors Urology Group, Torrance, California, and Watson Laboratories, Inc., Salt Lake City, Utah© 2002 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byStaskin D, Dmochowski R, Sand P, MacDiarmid S, Caramelli K, Thomas H and Hoel G (2018) Efficacy and Safety of Oxybutynin Chloride Topical Gel for Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled, Multicenter StudyJournal of Urology, VOL. 181, NO. 4, (1764-1772), Online publication date: 1-Apr-2009. Volume 168Issue 2August 2002Page: 580-586 Advertisement Copyright & Permissions© 2002 by American Urological Association, Inc.Keywordsurinary incontinencecholinergic antagonistsMetricsAuthor Information Roger R. Dmochowski More articles by this author G. Willy Davila More articles by this author Norman R. Zinner More articles by this author Marc C. Gittelman More articles by this author Daniel R. Saltzstein More articles by this author Sydney Lyttle More articles by this author Steven W. Sanders More articles by this author for THE TRANSDERMAL OXYBUTYNIN STUDY GROUP* Participants: Philip Aliotta, Williamsville, New York; Ronald Anderson, Tacoma, Washington; Joseph Antoci, Waterbury, Connecticut; Stephen Auerbach, Newport Beach, California; Teresa Beam, Indianapolis, Indiana; C. Brito, Phoenix, Arizona; Grady Bruce, Austin, Texas; Jim Christensen, Las Vegas, Nevada; G. Davila, Fort Lauderdale, Florida; Bradley Davis, Overland Park, Kansas; Roger Dmochowski, Fort Worth, Texas; Brian Feagins, Dallas, Texas; Roger Fincher, Spokane, Washington; Jeffery Frankel, Seattle, Washington; Marc Gittelman, Aventura, Florida; Lee Harbach, San Diego, California; Richard Harris, Melrose, Illinois; Terence Isakov, Lyndhurst, Ohio; Michael Kaempf, Portland, Oregon; Joel Kaufman, Aurora, Colorado; Ira Klimberg, Ocala, Florida; Dean Knoll, Nashville, Tennessee; R. Michael Kroeger, Omaha, Nebraska; Stuart Liberman, Melbourne, Florida; Murray Lieberman, Rockville, Maryland; Joel Lilly, Seattle, Washington; Edward Loizides, Bayshore, New York; James Mcmurray, Huntsville, Alabama; Myron Murdock, Greenbelt, Maryland; Diane Normandin, Clearwater, Florida; Steven Rosenberg, Des Moines, Iowa; Daniel Saltzstein, San Antonio, Texas; Paul Sieber, Lancaster, Pennsylvania; James Simon, Laurel, Maryland; Jeffrey Snyder, Denver, Colorado; Sammy Vick, San Antonio, Texas; W. Wells, Birmingham, Alabama; Mitchell Wiatrak, Milwaukee, Wisconsin; Jay Young, Laguna Woods, California; and Norman Zinner, Torrance, California. More articles by this author Expand All Advertisement PDF downloadLoading ...