NCT02131311已完成不适用
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Procter and Gamble2 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Percentage of Responders for Pad Weight Gain or SUI Episodes
研究概览
简要总结
This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •be female 18 years or older;
- •provide written informed consent prior to study participation and receive a signed copy;
- •be in generally good health as determined by the Investigator;
- •have a ≥ 3 month history of experiencing SUI (self reported);
- •be willing to use the pessary investigational device to control stress urinary incontinence;
- •be willing to comply with study requirements and instructions;
排除标准
- •pregnant, lactating or planning to become pregnant during the study;
- •within 3 months post partum;
- •intrauterine device (IUD) placement of less than 6 months;
- •has self-reported difficulty emptying her bladder;
- •a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
- •experience difficulty inserting or wearing an intra-vaginal device, including a tampon;
- •vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
- •has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the subject or the outcome of the study;
- •for any reason, the Investigator decides that the subject should not participate in the study.
结局指标
主要结局
Percentage of Responders for Pad Weight Gain or SUI Episodes
时间窗: from the 14-day baseline period to the last 7 days of 14-day device usage period
次要结局
- Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)(baseline and end-of-treatment)
- Percentage of Responders for Pad Weight Gain or SUI Episodes(from the 14-day baseline period to the first 7 days of 14-day device usage period)
- Change in Stress Urinary Incontinence Episodes(from the 14-day baseline period to the first 7 days of 14-day device usage period)
- Change in Pad Weight Gain(from the 14-day baseline period to the first 7 days of a 14-day device usage period)
研究者
研究点 (2)
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