A Randomized, Controlled Trial on the Safety, Efficacy, and Patient Reported Experience Comparing PureWick™ System With an Established Comparator Overnight in the Home Setting (PUREST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 29
- 主要终点
- Safety of the PureWick System in the home setting
研究概览
简要总结
This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.
详细描述
Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
- •Currently use diapers or equivalent at night for urine output management.
- •Willing to comply with all study procedures in this CIP.
- •Provision of signed and dated informed consent form.
排除标准
- •Has frequent episodes of bowel incontinence without a fecal management system in place; or
- •Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
- •Has urinary tract, vaginal or other chronic infections, active genital herpes; or
- •Has urinary retention; or
- •Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
- •Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
- •Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
- •Is known to be pregnant at time of enrollment (for women of childbearing age); or
- •Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
结局指标
主要结局
Safety of the PureWick System in the home setting
时间窗: From enrollment to the end of treatment at 4 weeks
Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation.
Performance of the PureWick System in the home setting
时间窗: From enrollment to the end of treatment at 4 weeks
Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight)
次要结局
- Participant Device Experience - Ease of Use(From enrollment to the end of treatment at 4 weeks)
- Participant Device Tolerance(From enrollment to the end of treatment at 4 weeks)
- Participant Device Experience - Comfort(From enrollment to the end of treatment at 4 weeks)