NCT02160314已完成不适用
A Clinical Study to Assess the 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 224 人开始时间: 2014年5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
- 224
- 试验地点
- 2
- 主要终点
- Treatment-emergent Serious Adverse Event
研究概览
简要总结
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 been given a signed copy;
- •be in generally good health as determined by the Investigator;
- •have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (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
- •are 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 and could impact the safety of the subject or the outcome of the study; or
- •for any reason, the Investigator decides that the subject should not participate in the study.
结局指标
主要结局
Treatment-emergent Serious Adverse Event
时间窗: 3 month
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
次要结局
未报告次要终点
研究者
研究点 (2)
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