Effect of raloxifene on urinary incontinence: a randomized controlled trial.
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.


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


METHODS
I
Waetjen
L Elaine
LE
Department of Obstetrics and Gynecology, University of California-Davis, 4860 Y Street, Suite 2500, Sacramento, CA 95817, USA. lewaetjen@ucdavis.edu
Brown
Jeanette S
JS
Modelska
Katharina
K
Blackwell
Terri
T
Vittinghoff
Eric
E
Cummings
Steven R
SR
D000284:Administration, Oral; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D016017:Odds Ratio; D017698:Postmenopause; D011336:Probability; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000175:diagnosis / Q000188:drug therapy*; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000188:drug therapy; D014563:Urodynamics
D020849:Raloxifene Hydrochloride