一种新型一次性阴道内装置治疗压力性尿失禁的疗效和安全性。
Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence.
作者信息
Ziv Elan, Stanton Stuart L, Abarbanel Joseph
机构信息
Urogynecology Service, Assuta Medical Centers, Tel Aviv, Israel.
出版信息
Am J Obstet Gynecol. 2008 May;198(5):594.e1-7. doi: 10.1016/j.ajog.2008.01.061. Epub 2008 Apr 2.
OBJECTIVE
The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women.
STUDY DESIGN
Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a > or = 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage.
RESULTS
Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a > or = 70% reduction in PWG (P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed.
CONCLUSION
The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.
目的
本研究旨在评估一种新型一次性阴道内装置治疗女性压力性尿失禁（SUI）的疗效和安全性。
研究设计
从以色列的2个地点招募了60名重度SUI女性，在为期7天的对照期内佩戴预先称重的护垫，随后是为期28天的装置使用期，在此期间每天佩戴装置和预先称重的护垫8小时。主要终点是从对照期到装置使用最后14天护垫重量增加（PWG）减少≥70%的女性百分比。
结果
纳入研究并在任何时间段使用该装置的60名女性被纳入意向性分析（ITT）人群。其中85%的女性PWG减少≥70%（P = 0.01）。观察到总体生活质量、对尿失禁的主观感受以及对该装置的满意度均有改善。
结论
该阴道内装置使用方便，耐受性良好，且在减轻SUI方面有效。
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