Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Patient Satisfaction in Device Use
研究概览
简要总结
The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.
详细描述
Following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. Others may be incontinent of urine. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed 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, or a condom-type urine collection device. These may be associated with skin irritation and infection.
The study will evaluate the UriCap-RM non-invasive urine collection device in hospitalized men.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥ 18 years old.
- •Empties the bladder completely on voiding
- •A clinical indication for an indwelling catheter, use of pads or diapers
- •Subject 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 - no discharge, itching, inflammation or skin condition - - on visual examination
- •Subject has no hypersensitivity to silicon.
排除标准
- •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 subject'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 subject or a family member
研究组 & 干预措施
UriCap-RM
The device is comprised of a reusable part and a single use adhesive tape. The device is removed once daily and the reusable part is rinsed, dried and reapplied with a new adhesive tape.
干预措施: UriCap-RM (Device)
结局指标
主要结局
Patient Satisfaction in Device Use
时间窗: 1-30 days
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
Performance of the device in collecting urine
时间窗: 1-30 days
Multiple variables will be assessed and their measurements aggregated to arrive at number of events reported: * Patient's anatomy does not enable application of the device * Leakage * Pooling of urine in the tubing * Tubing disconnections * Adhesive tape disconnections * Need for repositioning of device * Device malfunctions
Patient Comfort
时间窗: 1-30 days
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
Healthcare provider (HCP) satisfaction in device use
时间窗: up to 60 days
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
次要结局
- Number of patients with Adverse Events that are related to device use(1-30 days)
- Effectiveness of defined device cleaning procedure(1-30 days)
- Number of leakage events resulting from device movement(1-30 days)