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托特罗定联合阴道雌激素乳膏与单用托特罗定治疗绝经后女性膀胱过度活动症的随机对照研究

Randomized comparison of tolterodine with vaginal estrogen cream versus tolterodine alone for the treatment of postmenopausal women with overactive bladder syndrome.

作者信息

Tseng Ling-Hong, Wang Alex C, Chang Yao-Lung, Soong Yung-Kuei, Lloyd L Keith, Ko Yet-Jane

机构信息

Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and University of Chang Gung School of Medicine, Tao-Yuan, Taiwan.

出版信息

Neurourol Urodyn. 2009;28(1):47-51. doi: 10.1002/nau.20583.

DOI:10.1002/nau.20583
PMID:19089890
Abstract

AIMS

To investigate whether vaginal estrogen cream combined with tolterodine is more effective than tolterodine alone in the treatment of postmenopausal women with overactive bladder (OAB).

MATERIALS AND METHODS

This is an unblinded study without placebo. A preliminary study consisted of tolterodine 2 mg twice per day for 3 months had been conducted for 25 postmenopausal women with OAB. Over a period of 11 months, 80 postmenopausal women with OAB underwent a prospective randomized trial. These patients were equally randomized into two groups. The interventions for the 12-week treatment period included 2 mg tolterodine twice per day for the group A and 2 mg tolterodine twice per day/vaginal conjugated equine estrogen 0.625 mg twice a week for the group B. Identical pre- and post-treatment assessments included bladder diary, Urogenital Distress Inventory-6 (UDI-6), and Incontinence Impact Questionnaire-7 (IIQ-7).

RESULTS

All 80 women (65.2 years, range 58-73) completed this study. The between groups comparison showed that the group B had significant improvements in mean daytime frequency and voided volume after treatment (14.8-5.8 vs. 14.1-6.4, P = 0.001 and 115.8-141.9 vs. 108.5-134.5, P = 0.007, respectively). Additionally, a comparison of the final total scores of UDI-6 and IIQ-7 between the two groups revealed that the group B had a statistically significant improvement in quality of life than that in the group A (8.6-6.9 vs. 9.5-7.2, P < 0.001 and 9.4-6.1 vs. 10.2-6.5, P < 0.001, respectively). Changes in the other symptoms, including nocturia, urgency and urge incontinence, were not statistically significant but actually achieved improved in both groups.

CONCLUSIONS

A combination of vaginal estrogen cream and tolterodine is a potential therapy for postmenopausal women with OAB.

摘要

目的

探讨阴道雌激素乳膏联合托特罗定治疗绝经后膀胱过度活动症(OAB)女性是否比单用托特罗定更有效。

材料与方法

这是一项无安慰剂的非盲法研究。对25名绝经后OAB女性进行了一项初步研究,给予托特罗定2mg每日两次,持续3个月。在11个月的时间里,80名绝经后OAB女性进行了一项前瞻性随机试验。这些患者被平均随机分为两组。为期12周的治疗期内,A组的干预措施为托特罗定2mg每日两次,B组的干预措施为托特罗定2mg每日两次/阴道结合雌激素0.625mg每周两次。治疗前后相同的评估包括膀胱日记、泌尿生殖系统困扰量表-6(UDI-6)和尿失禁影响问卷-7(IIQ-7)。

结果

所有80名女性(平均年龄65.2岁,范围58 - 73岁)完成了本研究。组间比较显示,治疗后B组的平均日间排尿频率和排尿量有显著改善(分别为14.8 - 5.8对14.1 - 6.4,P = 0.001;115.8 - 141.9对108.5 - 134.5,P = 0.007)。此外,两组之间UDI-6和IIQ-7的最终总分比较显示,B组在生活质量方面的改善在统计学上显著优于A组(分别为8.6 - 6.9对9.5 - 7.2,P < 0.001;9.4 - 6.1对10.2 - 6.5,P < 0.001)。其他症状的变化,包括夜尿、尿急和急迫性尿失禁,虽无统计学意义,但两组实际上均有改善。

结论

阴道雌激素乳膏与托特罗定联合使用是绝经后OAB女性的一种潜在治疗方法。

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