NCT06347380已完成不适用
Usability Study of the FemPulse System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Patient Satisfaction
研究概览
简要总结
The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician
- •Able to read, comprehend, and reliably provide informed consent and study-related information.
- •Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
- •Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.
排除标准
- •Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
- •Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
- •Not an appropriate study candidate as determined by investigator.
研究组 & 干预措施
Subjects receiving FemPulse System
Experimental
Subjects will receive the Ring for the treatment of their OAB symptoms
干预措施: FemPulse System (Device)
结局指标
主要结局
Patient Satisfaction
时间窗: 28 days
Proportion of subjects reporting satisfaction with the use of the FemPulse System
次要结局
未报告次要终点
研究者
研究点 (2)
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