Issn Print: 1071-5754
Publication Date: 2005/05/01
CONTROLLED TRIAL OF DULOXETINE ALONE, PELVIC FLOOR MUSCLE TRAINING ALONE, COMBINED TREATMENT, AND NO TREATMENT IN WOMEN WITH STRESS URINARY INCONTINENCE: 674
Denise M. Elser; Gamal M. Ghoniem; Jules Schagen Van Leeuwen; Robert M. Freeman; Yan D. Zhao; Ilker Yalcin; Richard C. Bump
Excerpt
PURPOSE: The primary aim was to compare the effectiveness of combined pelvic floor muscle training (PFMT) and duloxetine with imitation PFMT and placebo for 12 weeks in women with stress urinary incontinence (SUI). Secondary aims were to compare the effectiveness of combined treatment with single treatments, single treatments with each other, and single treatments with no treatment. METHODS: This blinded doubly-controlled randomized trial enrolled 201 women aged 18-75 years with SUI at 17 incontinence centers in the Netherlands, United Kingdom, and United States. Women averaged at least 2 incontinence episodes/day and were randomized to 1 of 4 combinations of duloxetine 80 mg/day, placebo, PFMT, and imitation PFMT, including combined treatment (n = 52), no active treatment (n = 47), PFMT only (n = 50), and duloxetine only (n = 52). The primary efficacy measure was incontinence episode frequency (IEF). Other efficacy variables included the number of continence pads used and the Incontinence Quality of Life (I-QOL) questionnaire score. RESULTS: The intent-to-treat population IEF analysis demonstrated the superiority of duloxetine, with or without PFMT, compared with either no treatment or with PFMT alone. However, both pad and I-QOL analyses suggested greater improvement with combined treatment than single treatment. A more complete population analysis demonstrated the efficacy of duloxetine with or without PFMT and suggested combined treatment was more effective than either treatment alone. CONCLUSIONS: The data support significant efficacy of combined PFMT and duloxetine in the treatment of women with SUI. We hypothesize that complementary modes of action of duloxetine and PFMT may result in an additive effect of combined treatment.
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