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Obstetrics & Gynecology 2004;103:261-266
© 2004 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Effect of Raloxifene on Urinary Incontinence: A Randomized Controlled Trial

L. Elaine Waetjen, MD, Jeanette S. Brown, MD, Katharina Modelska, MD, Terri Blackwell, MA, Eric Vittinghoff, PhD and Steven R. Cummings, MD for the MORE Study Group

From the Department of Obstetrics and Gynecology, University of California, Davis; Department of Epidemiology and Biostatistics, University of California, San Francisco; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco; and San Francisco Coordinating Center, Research Institute at California Pacific Medical Center, San Francisco, California.

Address reprint requests to: L. Elaine Waetjen, MD, Assistant Professor, Department of Obstetrics and Gynecology, 4860 Y Street, Suite 2500, Sacramento, CA 95817; e-mail: lewaetjen{at}ucdavis.edu.

OBJECTIVE: To estimate the effect of 3 years of treatment with raloxifene on urinary incontinence in postmenopausal women.

METHODS: We used measures of urinary incontinence severity, frequency, and type in the Multiple Outcomes of Raloxifene trial, a multicenter randomized, controlled trial of women who were at least 2 years postmenopausal with osteoporosis. At 10 U.S. sites of this trial, 963 women randomly assigned to raloxifene or placebo completed questionnaires about incontinence at baseline and 3 years later. We analyzed the odds of worsening severity and frequency of incontinence and type of incontinence after 3 years of treatment with raloxifene.

RESULTS: The mean age of our subjects was 68.3 ± 7 years. After 3 years of treatment, there was no significant difference between raloxifene and placebo groups in urinary incontinence severity (multivariable odds ratio [OR] 1.02; 95% [CI] 0.78, 1.34). The majority of the women (60%) had no change in urinary incontinence episodes from baseline to year 3. The odds of worsening urinary incontinence severity after 3 years of raloxifene treatment were 1.05 (95% CI 0.75, 1.48). Similarly, the odds of developing new onset incontinence were 0.95 (95% CI 0.59, 1.52). Finally, raloxifene did not effect the odds of having stress (OR 1.01; 95% CI 0.71, 1.43) or urge (OR 1.20; 95% CI 0.86, 1.68) incontinence after 3 years of use.

CONCLUSION: In postmenopausal women with osteoporosis, 3 years of treatment with raloxifene had no effect on urinary incontinence.

LEVEL OF EVIDENCE: I




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