Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Number of Adverse Device Events
研究概览
简要总结
The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine collection device for women, in hospitalized patients who would otherwise be treated with an indwelling catheter, pads or diapers.
详细描述
Following various disease conditions such as trauma, orthopaedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. For lack of a better solution for urinary management, indwelling catheter and diaper use is common in hospitalized patients. There is no externally applied urine collection device on the market today for women. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated, despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used. These may be associated with skin irritation and infection.
The study will evaluate the UriCap-F, non-invasive urine collection devices for women, in hospitalized patients who are able to void or who are incontinent of urine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ≥ 18 years old
- •Empties the bladder completely on voiding
- •A clinical indication for an indwelling catheter, use of pads or diapers
- •Patient has signed an informed consent form, is cooperative and willing to complete all study procedures
- •Absence of localized disease at the site of device application - vaginal discharge, itching, inflammation or skin condition
- •Agrees to genital hair removal.
排除标准
- •Pregnant or breastfeeding
- •Menstruation at time of enrolment
- •Known allergy to silicon
- •Urinary retention - Post-void residual urine more than 300cc
- •Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
- •Diagnosed with acute renal failure according, to investigator judgement.
- •Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the patient's well-being or successful participation in the study
- •Participating in another clinical study.
- •Financial interest in the Sponsor Company or a competitor company by patient or a family member
结局指标
主要结局
Number of Adverse Device Events
时间窗: 1-30 days
Use Safety as demonstrated by System Usability Score assessed by healthcare providers
时间窗: 1 week
Effectiveness of the device to collect urine
时间窗: 1-30 days
Multiple variables will be assessed and their measurements aggregated to arrive at a number of events reported: * Leakage * Pooling of urine in the tubing * Tubing disconnections * Adhesive tape disconnections * Need for repositioning of device * Device malfunctions
Patient satisfaction in device use
时间窗: 1-30 days
Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.
Healthcare provider (HCP) satisfaction
时间窗: up to 60 days
Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients
Patient Comfort
时间窗: 1-30 days
Comfort will be assessed by means of the "Universal Pain Assessment Scale" of 1-10, At every device application, every removal, and when patient complains of discomfort or pain.
次要结局
- Effectiveness of defined device cleaning procedure for reuse(1-30 days)
- Leakage as a result of device movement(1-30 days)