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Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Postmenopausal hormones and incontinence: the Heart and Estrogen/Progestin Replacement Study.
Obstetrics and Gynecology 2001 January
OBJECTIVE: To determine whether postmenopausal hormone therapy improves the severity of urinary incontinence.
METHODS: We included measures of incontinence and voiding frequency in the Heart and Estrogen/Progestin Replacement Study, a randomized, blinded trial of the effect of hormone therapy among 2763 postmenopausal women younger than 80 years with coronary disease and intact uteri. This report includes 1525 participants who reported at least one episode of incontinence per week at baseline. Participants were randomly assigned to 0.625 mg of conjugated estrogens plus 2.5 mg of medroxyprogesterone acetate in one tablet daily (n = 768) or placebo (n = 757) and were followed for a mean of 4.1 years. Severity of incontinence was classified as improved (decrease of at least two episodes per week), unchanged (change of at most one episode per week), or worsened (increase of at least two episodes per week).
RESULTS: Incontinence improved in 26% of the women assigned to placebo compared with 21% assigned to hormones, while 27% of the placebo group worsened compared with 39% of the hormone group (P =.001). This difference was evident by 4 months of treatment and was observed for both urge and stress incontinence. The number of incontinent episodes per week increased an average of 0.7 in the hormone group and decreased by 0.1 in the placebo group (P <.001).
CONCLUSION: Daily oral estrogen plus progestin therapy was associated with worsening urinary incontinence in older postmenopausal women with weekly incontinence. We do not recommend this therapy for the treatment of incontinence.
METHODS: We included measures of incontinence and voiding frequency in the Heart and Estrogen/Progestin Replacement Study, a randomized, blinded trial of the effect of hormone therapy among 2763 postmenopausal women younger than 80 years with coronary disease and intact uteri. This report includes 1525 participants who reported at least one episode of incontinence per week at baseline. Participants were randomly assigned to 0.625 mg of conjugated estrogens plus 2.5 mg of medroxyprogesterone acetate in one tablet daily (n = 768) or placebo (n = 757) and were followed for a mean of 4.1 years. Severity of incontinence was classified as improved (decrease of at least two episodes per week), unchanged (change of at most one episode per week), or worsened (increase of at least two episodes per week).
RESULTS: Incontinence improved in 26% of the women assigned to placebo compared with 21% assigned to hormones, while 27% of the placebo group worsened compared with 39% of the hormone group (P =.001). This difference was evident by 4 months of treatment and was observed for both urge and stress incontinence. The number of incontinent episodes per week increased an average of 0.7 in the hormone group and decreased by 0.1 in the placebo group (P <.001).
CONCLUSION: Daily oral estrogen plus progestin therapy was associated with worsening urinary incontinence in older postmenopausal women with weekly incontinence. We do not recommend this therapy for the treatment of incontinence.
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