Raloxifene effect on frequency of surgery for pelvic floor relaxation

OBJECTIVE: To assess the effects of raloxifene therapy on the frequency of surgery for pelvic floor relaxation in postmenopausal women. METHODS: This analysis used safety data through 3 years of treatment from t hree double-masked, placebo-con trolled, randomized trials of raloxifene, w hich included 6926 postmenopausal women with uteri at entry. Studies 1 and 2 enrolled 969 nonosteoporotic, postmenopausal women who were assigned to 3 0, 60, or 150 mg per day raloxifene or placebo. Study 3 enrolled 5957 osteo porotic, postmenopausal women randomized to raloxifene 60 or 120 mg per day or placebo. Indications for any reported pelvic operations were identified , including procedures performed for pelvic organ prolapse or urinary incon tinence. RESULTS: A total of 34 (1.51%) women in the placebo group and 35 (0.75%) ra loxifene-treated women underwent surgical procedures for pelvic floor relax ation. The odds ratio land 95% confidence interval) for pelvic floor repair in women assigned to raloxifene was 0.50 (0.31 0.81). Thus, raloxifene the rapy was associated with a significantly reduced risk for pelvic floor surg ery (P < .005). CONCLUSION: Raloxifene does not increase pelvic floor relaxation, An appare nt protective effect on pelvic floor function warrants further investigatio n. (C) 2001 by the American College of Obstetricians and Gynecologists.