Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Safety: Reliability
研究概览
简要总结
The fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.
详细描述
The objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term IDC and the feasibility of undertaking future community-based evaluation.
To do this the investigators will
- determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients;
- determine if the valve functions effectively i.e. allows for the complete bladder emptying (< 100ml post void residual) during rest and daily activities;
- determine if the process of filling and automatic draining is comfortable and acceptable for participants;
- collect preliminary data on the potential for bioburden/biofilm following in human use of the valve;
- assess the feasibility of undertaking a future randomised control trial of the valve.
Group 1 - The investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation.
Group 2- The Investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine
- •Independent with catheter care needs (e.g. bag emptying or valve opening)
- •Able to transfer from bed to chair, stand and walk short distances unaided
- •Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter)
- •Able to provide informed consent (self-report and research nurse assessment)
- •Usual medical provider provides confirmation of suitability
排除标准
- •End stages of a terminal illness
- •Current treatment of urinary tract infection
- •Has been advised by a urologist against using a valve on clinical grounds
- •Lack of bladder sensation (e.g. unable to sense when bladder needs emptying)
- •Previous bladder surgery that could affect the integrity of the bladder
- •At known risk of autonomic dysreflexia
结局指标
主要结局
Safety: Reliability
时间窗: An average of 16 hours in total
Valve opening - Proportion of observations of automatic valve opening before bladder capacity (500ml or less) is reached - as measured by bladder scanner
Comfort
时间窗: An average of 16 hours in total
Participant report (Valve self-report questionnaire)
Safety: Effectiveness
时间窗: An average of 16 hours in total
Bladder emptying - proportion of valve voids with residual urine \<100ml - as measured by bladder scanner.
次要结局
- User acceptability(An average of 16 hours in total)