A Multi-centre Prospective Observational Study of the User Experience of Catheterisation and Quality of Life in Patients Prescribed GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation
研究概览
简要总结
Male self catherterisng observational study.
详细描述
This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCath™ Intermittent Catheter with FeelClean™ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires.
Difficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCath™ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed.
Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •• Adult male (aged 18 years and over)
- •Diagnosed with a neurological lower urinary tract dysfunction due to either spinal cord injury, Multiple Sclerosis, Parkinson's Syndrome, Cauda equina syndrome Or Diagnosed with bladder outflow obstruction secondary to benign prostate enlargement Or Diagnosed with detrusor underactivity
- •Performing single use clean intermittent self-catheterisation (ISC) at least twice a day
- •Willing to undergo training with GC Trainer video prior to use of catheter
- •Provided fully informed consent and has sufficient understanding of English or French
- •Sufficient dexterity to use GentleCath™ Air for Men intermittent including ability to open packaging
- •Intact urethral sensation of catheterisation
- •Willing to use only the GentleCath™ Air intermittent catheter for the full duration of the study (60-days)
- •Subject has a valid email address so the Investigator can send links to study questionnaires and the subject has access to a web enabled device
排除标准
- •• Participation in another related urological study
- •Unable to perform ISC unaided
- •Already prescribed the GentleCath™ Air Intermittent Catheter
- •Absent urethral or perineal sensation
- •Unwilling to undergo training with GC Trainer prior to use of catheter
- •Insufficient dexterity to use GentleCath™ Air Intermittent Catheter and or packaging
- •Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion or in the preceding 6-weeks
- •Undergoing surgical treatment during the period of the study
- •Performing catheterisation for urethral stricture
结局指标
主要结局
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation
时间窗: 60 days
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q
次要结局
- To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection(60 days)
- To assess compliance with the self-catheterization for the study duration(60 days)