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


METHODS
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).


CONCLUSIONS
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.
Goldstein
Steven R
SR
Department of OB/GYN, New York University Medical Center, New York, NY 10016, USA. Steven.Goldstein@med.nyu.edu
Johnson
Susan
S
Watts
Nelson B
NB
Ciaccia
Angelina V
AV
Elmerick
Derek
D
Muram
David
D
D000328:Adult; D001315:Australia / Q000453:epidemiology; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D017698:Postmenopause; D015995:Prevalence; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D012720:Severity of Illness Index; D013019:South Africa / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014550:Urinary Incontinence, Stress / Q000453:epidemiology* / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*
D004966:Estrogens, Conjugated (USP); D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride