A Randomized, Controlled Crossover Study on the Safety, Efficacy, and Patient Reported Outcome Measures Comparing the PureWick™ System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 22
- 主要终点
- Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
研究概览
简要总结
This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.
详细描述
Approximately 100 adult men requiring the use of diapers, pads or equivalent at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick™ System (PureWick™ Male External Catheter & PureWick™ Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary endpoint is the mean urine capture rate. The secondary endpoints include the number of device-related AEs requiring medical intervention (safety), device satisfaction and preference questionnaires, and sleep disturbance (quality of life). Capture rates and adverse events are assessed daily throughout each 7-day treatment phase. Patient satisfaction is assessed at the end of each treatment phase. Patient preference is evaluated at study completion. Sleep disturbance is assessed at baseline and every 7 days during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male participants ≥ 18 years of age at the time of signing the informed consent
- •Male anatomy at the time of enrollment
- •Currently use diapers, pads, or equivalent at night for urine output management
- •Willing to comply with all study procedures in this protocol
- •Provision of signed and dated informed consent form
排除标准
- •Has frequent episodes of bowel incontinence; or
- •Has chronic urinogenital infections, active genital herpes; or
- •Has Urinary retention; or
- •Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; or
- •Has experience using study devices in the home setting within the last year; or
- •Is agitated, combative, and/or uncooperative and may remove the external catheter; or
- •Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
- •Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
- •Is considered a vulnerable population.
研究组 & 干预措施
Treatment Sequence 1
PureWick System used first, followed by crossover to UltraFlex
干预措施: PureWick System (Device)
Treatment Sequence 1
PureWick System used first, followed by crossover to UltraFlex
干预措施: UltraFlex Self-Adhering Male External Catheter (Device)
Treatment Sequence 2
UltraFlex is used first, followed by crossover to PureWick System
干预措施: PureWick System (Device)
Treatment Sequence 2
UltraFlex is used first, followed by crossover to PureWick System
干预措施: UltraFlex Self-Adhering Male External Catheter (Device)
结局指标
主要结局
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
时间窗: From enrollment up to 14 days of treatment
Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, 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
- Number of device-related adverse events requiring medical intervention(From enrollment up to 14 days of treatment)
- Participant Device Satisfaction(Day 7 and Day 14, or at the time of treatment discontinuation, whichever comes first.)
- Participant Device Preference(Day 15, or at the time of study discontinuation, whichever comes first.)
- Participant Sleep Quality(Starting at baseline and then after Day 7 and after Day 14)