A Uresta Bladder Support Handle Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- questionnaire
研究概览
简要总结
The goal of this clinical trial is to learn if a new handle design for the uresta pessary works better than the current handle design for women when they are using the pessary. The main questions it aims to answer are:
Is the new pessary equally effective for users. Do pessary users find the new handle design is more or less helpful for insertion and removal of the pessary Is the optional removal string, provided with the new handle, helpful in pessary handling.
The participants will use both the original and the new uresta pessary handle designs and complete a questionnaire to rate both handles.
The score for the two questionnaires will be compared to determine which handle is best.
详细描述
- Introduction This research is a usability comparison study involving the Uresta bladder support, a Class II medical device indicated for adult women experiencing stress urinary incontinence. The device is Food and Drug Administration (FDA)-cleared and licensed for over-the-counter use. The study will compare user experience using the current Uresta handle design and a modified handle design intended to improve the removal process.
- Study Objective The purpose of this study is to obtain feedback from intended users regarding the efficacy and ease of use and removal characteristics of two versions of the Uresta bladder support handle. The study will also collect feedback on an optional removal string which will be made available to further facilitate removal for certain users.
- Background Uresta® is a reusable bladder support device designed to reduce urine leakage caused by stress urinary incontinence. When inserted into the vaginal canal, the device supports the urethra and reduces involuntary urine loss during physical activity such as coughing, laughing, or exercising.
The efficacy, safety and usability of the use of the uresta pessary for the treatment of bladder leaking has been extensively investigated and the results published1-5 Post-market surveillance has identified potential improvements related to the device. User feedback suggested possible modifications including adding a finger hole to the handle, increasing handle stiffness, and providing an optional removal string to help locate the device during removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Adult women aged 18 years or older
- •Currently using a Uresta bladder support successfully
- •Using size 3, 4, or 5 from the Uresta Starter Kit
- •Living in the United States
- •Able to participate within 10-20 days of consent
- •Willing to complete study questionnaires and use the modified device
排除标准
- •Individuals not residing in the United States
- •Individuals not currently using Uresta
- •Individuals using sizes other than 3, 4, or 5
- •Individuals unable to complete study activities within the study timeline
- •Pregnant women
结局指标
主要结局
questionnaire
时间窗: From enrolment to completion at 4 weeks
A 15 item questionnaire in which each question is anwered on a 5-point likert scale ranging from "strongly disagree"=1 to strongly agree = 5. The higher the score the better the usability and efficacy
Paired samples t-test
时间窗: from enrollment to completion at 4 weeks
The scores of each questionnaire will be summed and the mean scores on the pessary handle questionnaires will be compared using a paired samples t-test with a p\<0.05 considered significant
次要结局
未报告次要终点
研究者
Scott Farrell
Professor Emeritus
Resilia Inc.