Incidence of urinary incontinence in postmenopausal women treated with raloxifene or estrogen.

Author(s): Goldstein SR, Johnson S, Watts NB, Ciaccia AV, Elmerick D, Muram D

Affiliation(s): Department of OB/GYN, New York University Medical Center, New York, NY 10016, USA. Steven.Goldstein@med.nyu.edu

Publication date & source: 2005-03, Menopause., 12(2):160-4.

Publication type:

OBJECTIVE: Determine the effect of raloxifene or estrogen, as compared with placebo, on the reporting of urinary incontinence in postmenopausal women participating in an osteoporosis prevention trial. DESIGN: The current analysis is based on adverse event data that were collected as part of a double-blind, randomized, placebo-controlled trial designed to assess the efficacy and safety of raloxifene for osteoporosis prevention in postmenopausal women. Women were 40 to 60 years of age at study entry and had a prior hysterectomy. A total of 619 women were randomized to placebo, raloxifene 60 or 150 mg/d, or conjugated equine estrogen 0.625 mg/d and followed for up to 3 years. Urinary incontinence was self-reported and rated by participants as "mild," "moderate," or "severe." RESULTS: The prevalence of urinary incontinence as reported by patients at baseline was similar across treatment groups (3% to 6%, P = 0.46). During 3 years of follow-up, new or worsening urinary incontinence was reported with the following frequency: placebo (1.3%), raloxifene 60 mg/d (0.7%), raloxifene 150 mg/d (0.6%), and conjugated equine estrogen (7.0%). The percentage of estrogen subjects reporting urinary incontinence was significantly greater than that for placebo and both doses of raloxifene (P < or = 0.02). CONCLUSION: During 3 years of follow-up, conjugated equine estrogen was associated with an increased incidence of reports of urinary incontinence in women with a prior hysterectomy and this was significantly greater than both placebo and raloxifene.