NCT00397202已完成不适用
FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Overall satisfaction with menstrual strategy.
研究概览
简要总结
- Purpose: To compare the use of the menstrual cup "The DivaCupTM " to a menstrual strategy using tampons as the primary method of menstrual flow management using indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and waste.
- Hypothesis: The "The DivaCupTM" will have similar rates of user-satisfaction, urinary tract infection, and vaginal irritation as a menstrual strategy using tampons as the primary method of menstrual flow management but will likely be more reasonable in terms of cost and will generate less waste.
详细描述
Method:
Prospective study of 100 women from family practice offices in Vancouver, Victoria and Prince George who currently use tampons to manage menstrual flow. After an information session and consent, subjects will be randomized to tampon use or Diva Cup use and record their experience on a diary for 3 months. Women who attend the information session and who do not enrol, or those who drop out will be asked their reasons for discontinuing, and their pre-study questionnaire will be used for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 19 and 40 who have menstrual flow most months and who currently self-identify as using tampons as their primary method of menstrual management
排除标准
- •Have a sensitivity or allergy to silicone
- •Have an active vaginal or urogenital infection
- •Are pregnant, or who have plans to become pregnant before spring 2007 (end of study data collection)
- •Have used systemic antimicrobials within the previous 14 days
- •Are unable to understand the nature and purpose of the study
- •Are unable to understand and express themselves in written and spoken English
结局指标
主要结局
Overall satisfaction with menstrual strategy.
次要结局
- Diagnosed UTI
- Waste
- Cost
- Vaginal irritation
- Diagnosed vaginitis
研究者
研究点 (1)
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