Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Performance of the PureWick MEC Against an Established Comparator
研究概览
简要总结
A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PureWick (PW) Male external catheter (MEC) vs. comparator Sage PrimoFit™. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter as compared to the comparator product.
详细描述
In this prospective, post-market, crossover, single-blind, single center healthy volunteer study, healthy males will be randomized 1:1 to a treatment sequence using two devices (PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 evaluable subjects. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter.
The purpose of this study is to provide clinical evidence to compare the effectiveness and comfort of PureWick™ Male against a comparator for non-invasive urine output management in patients with varying male anatomy. Specifically, the study will collect data about how the male external catheters perform when participants are positioned on their side using a turning wedge with the head of the bed elevated, mimicking common patient positioning in the hospital setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to which device is which and will remain blinded to treatment order until study completion. Investigator, Study Personnel and Sponsor will know which device the participant is treated with at any given time.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult Male Patient ≥ 18 years old
- •Male anatomy at time of enrollment
- •Ability to speak and understand English
- •Willing to comply with all study procedures in this protocol
- •Able to independently void urine
- •Provision of signed and dated informed consent form
排除标准
- •Urinary incontinence which does not allow the subject to spontaneously void
- •Frequent episodes of bowel incontinence
- •Has Urinary Retention
- •Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum
- •Recent surgery of the external urogenital tract, penis, or pubic area
- •Not able to comply with study procedures independently without required assistance
- •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
Performance of the PureWick MEC Against an Established Comparator
时间窗: Approximately 2 hours after device placement
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100.
次要结局
- Performance of the PureWick MEC in Morbidly Obese Subpopulation(Approximately 2 hours after device placement)
- Participant Comfort(Approximately 2 hours after device placement)
- Participant Comfort Scale Survey(Approximately 2 hours after device placement)
- Ease of Use by Health Care Professional (HCP)(Approximately 2 hours after device placement)