Waetjen L Elaine, Brown Jeanette S, Vittinghoff Eric, Ensrud Kristine E, Pinkerton JoAnn, Wallace Robert, Macer Judith L, Grady Deborah
Department of Obstetrics and Gynecology, University of California-Davis, 4860 Y Street, Suite 2500, Sacramento, CA 95817, USA.
Obstet Gynecol. 2005 Nov;106(5 Pt 1):946-52. doi: 10.1097/01.AOG.0000182576.48290.6d.
To estimate the effect of 2 years of treatment with ultralow-dose transdermal estradiol (E2) on incontinence in postmenopausal women.
Ultra Low Dose Transdermal estRogen Assessment (ULTRA) was a multicenter, randomized, double-blinded, placebo-controlled trial of unopposed ultralow-dose (0.014 mg/d) transdermal E2 for prevention of osteoporosis in 417 postmenopausal women aged 60 to 80 years. Frequency of incontinence episodes was assessed at baseline and after 4 months and 2 years of treatment using a self-reported questionnaire. We used an intention-to-treat analysis to compare change in incontinence frequency, improved (decreased 2 or more episodes per week), unchanged (increased or decreased no more than 1 episode per week), or worsened (increased 2 or more episodes per week) between the E2 and placebo groups among women with and without at least weekly incontinence at baseline.
At baseline, the prevalence of at least weekly incontinence was similar between E2 and placebo groups (43%). After 2 years, there was no difference between groups in the proportions of women with incontinence at baseline whose incontinence improved, worsened, or was unchanged. The odds ratio for worsening incontinence in the E2 compared with placebo group was 1.35 (95% confidence interval 0.75-2.42. In women without incontinence at baseline, the odds of developing at least weekly incontinence after 2 years in the E2 compared with placebo group was not significant (odds ratio 1.2, 95% confidence interval 0.7-2.2).
Two years of treatment with unopposed ultralow-dose transdermal E2 did not substantially change the frequency of incontinence symptoms or alter the risk of developing at least weekly incontinence.
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评估超低剂量经皮雌二醇（E2）治疗2年对绝经后女性尿失禁的影响。
超低剂量经皮雌激素评估（ULTRA）是一项多中心、随机、双盲、安慰剂对照试验，对417名60至80岁的绝经后女性使用无对抗的超低剂量（0.014 mg/d）经皮E2预防骨质疏松症。使用自我报告问卷在基线时以及治疗4个月和2年后评估尿失禁发作的频率。我们采用意向性分析来比较E2组和安慰剂组之间尿失禁频率的变化，分为改善（每周减少2次或更多次发作）、不变（每周增加或减少不超过1次发作）或恶化（每周增加2次或更多次发作），这些女性在基线时有无至少每周一次的尿失禁。
在基线时，E2组和安慰剂组至少每周尿失禁的患病率相似（43%）。2年后，基线时有尿失禁的女性中，尿失禁改善、恶化或不变的比例在两组之间没有差异。与安慰剂组相比，E2组尿失禁恶化的优势比为1.35（95%置信区间0.75 - 2.42）。在基线时无尿失禁的女性中，与安慰剂组相比，E2组2年后至少每周发生一次尿失禁的几率无显著差异（优势比1.2，95%置信区间0.7 - 2.2）。
无对抗的超低剂量经皮E2治疗2年并未显著改变尿失禁症状的频率，也未改变至少每周发生一次尿失禁的风险。
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