Pharmacologic treatment for urgency-predominant urinary incontinence in women diagnosed using a simplified algorithm: a randomized trial

• Published in: American journal of obstetrics and gynecology 2012-05, Vol.206 (5), p.444.e1-444.e11
• Main Authors: Huang, Alison J., MD, MAS, Hess, Rachel, MD, MS, Arya, Lily A., MD, Richter, Holly E., PhD, MD, Subak, Leslee L., MD, Bradley, Catherine S., MD, MSCE, Rogers, Rebecca G., MD, Myers, Deborah L., MD, Johnson, Karen C., MD, MPH, Gregory, W. Thomas, MD, Kraus, Stephen R., MD, Schembri, Michael, BS, Brown, Jeanette S., MD
• Format: Article
• Language: English
• Subjects: Aged; Algorithms; antimuscarinic therapy; Benzhydryl Compounds - therapeutic use; Biological and medical sciences; Decision Support Techniques; diagnostic algorithm; Double-Blind Method; Female; fesoterodine; Follow-Up Studies; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Middle Aged; Muscarinic Antagonists - therapeutic use; Nephrology. Urinary tract diseases; Obstetrics and Gynecology; Surveys and Questionnaires; Treatment Outcome; urgency incontinence; Urinary Incontinence, Urge - diagnosis; Urinary Incontinence, Urge - drug therapy; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2012.03.002

Objective The purpose of this study was to evaluate clinical outcomes associated with the initiation of treatment for urgency-predominant incontinence in women diagnosed by a simple 3-item questionnaire. Study Design We conducted a multicenter, double-blinded, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence in ambulatory women diagnosed by the simple 3-item questionnaire. Participants (N = 645) were assigned randomly to fesoterodine therapy (4-8 mg daily) or placebo. Urinary incontinence was assessed with the use of voiding diaries; postvoid residual volume was measured after treatment. Results After 12 weeks, women who had been assigned randomly to fesoterodine therapy reported 0.9 fewer urgency and 1.0 fewer total incontinence episodes/day, compared with placebo ( P ≤ .001). Four serious adverse events occurred in each group, none of which was related to treatment. No participant had postvoid residual volume of ≥250 mL after treatment. Conclusion Among ambulatory women with urgency-predominant incontinence diagnosed with a simple 3-item questionnaire, pharmacologic therapy resulted in a moderate decrease in incontinence frequency without increasing significant urinary retention or serious adverse events, which provides support for a streamlined algorithm for diagnosis and treatment of female urgency-predominant incontinence.