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 three double-masked, placebo-controlled, randomized trials of raloxifene, which included 6926 postmenopausal women with uteri at entry. Studies 1 and 2 enrolled 969 nonosteoporotic, postmenopausal women who were assigned to 30, 60, or 150 mg per day raloxifene or placebo. Study 3 enrolled 5957 osteoporotic, 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 incontinence.


RESULTS
A total of 34 (1.51%) women in the placebo group and 35 (0.75%) raloxifene-treated women underwent surgical procedures for pelvic floor relaxation. The odds ratio (and 95% confidence interval) for pelvic floor repair in women assigned to raloxifene was 0.50 (0.31, 0.81). Thus, raloxifene therapy was associated with a significantly reduced risk for pelvic floor surgery (P <.005).


CONCLUSIONS
Raloxifene does not increase pelvic floor relaxation. An apparent protective effect on pelvic floor function warrants further investigation.
Goldstein
S R
SR
Department of Obstetrics and Gynecology, New York University Medical Center, New York, New York, USA. steven.goldstein@med.nyu.edu
Neven
P
P
Zhou
L
L
Taylor
Y L
YL
Ciaccia
A V
AV
Plouffe
L
L
D000368:Aged; D013509:Gynecologic Surgical Procedures / Q000706:statistics & numerical data*; D006801:Humans; D008875:Middle Aged; D009126:Muscle Relaxation / Q000187:drug effects; D017773:Pelvic Floor; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000494:pharmacology*; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000494:pharmacology*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride