Feasibility and Acceptability of an Anti-fouling Silicone Urinary Catheter for Long-term Catheterisation: a Single-centre, Single-blind Randomised Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retention through the monthly catheter-change protocol
研究概览
简要总结
This single-centre randomised pilot and feasibility study assessed whether an anti-fouling zwitterionic silicone urinary catheter can be deployed and evaluated in frail, elderly adults who require long-term indwelling catheterisation. In the experimental catheter, a zwitterionic polymer is blended into the silicone matrix rather than applied as a surface coating. Forty participants were randomly allocated to the anti-fouling catheter or a conventional commercial silicone catheter, with monthly catheter changes for up to eight cycles. The primary aim was to establish feasibility and acceptability (recruitment, retention, specimen completeness, safety and patient/family acceptability) and to obtain exploratory effect-size estimates (catheter-associated urinary tract infection, catheter-removal pain, urinalysis and urine culture) to inform the design of a future confirmatory trial. The study was not powered to test efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Experimental and control catheters were identical in appearance and packaging and dispensed by research staff so that participants were masked. Laboratory outcome assessment was masked. Caregivers within the institution were aware of allocation for clinical management.
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
- •Adults aged 18 years or older
- •Require long-term indwelling urethral catheterisation
- •At risk of catheter-associated urinary tract infection
- •Written informed consent from the participant or a legal representative
排除标准
- •Individuals who are not fully conscious or unable to clearly express their wishes
- •Individuals who cannot cooperate with urine or blood tests or other related examinations
研究组 & 干预措施
Anti-fouling catheter
Anti-fouling zwitterionic silicone urinary catheter, changed monthly for up to eight cycles (n=24).
干预措施: Anti-fouling zwitterionic silicone urinary catheter (Device)
Conventional catheter
Conventional commercial silicone Foley catheter of identical French size, changed monthly for up to eight cycles (n=16).
干预措施: Conventional silicone urinary catheter (Device)
结局指标
主要结局
Retention through the monthly catheter-change protocol
时间窗: Up to 8 monthly cycles
Proportion of participants completing at least one, and 5 or more, monthly catheter changes (feasibility outcome)
Completeness of longitudinal specimen collection
时间窗: Up to 8 monthly cycles
Proportion of expected urinalysis and urine-culture specimens collected (feasibility outcome)
Device-related adverse events
时间窗: Up to 8 monthly cycles
Number of device-related adverse events (safety feasibility outcome)
次要结局
- Catheter-associated urinary tract infection (CAUTI) incidence(Up to 8 monthly cycles)
- Catheter-removal pain measured by the Visual Analogue Scale (VAS)(At each monthly catheter change, up to 8 cycles)
- Urinalysis white blood cell count(At each monthly visit, up to 8 cycles)
- Urine occult blood(At each monthly visit, up to 8 cycles)
- Urinary bacteria on microscopic urinalysis(At each monthly visit, up to 8 cycles)
- Urine nitrite(At each monthly visit, up to 8 cycles)
- Urine culture positivity(At each monthly visit, up to 8 cycles)
研究者
Yuan-Yow Chiou
Professor / Attending Physician
National Cheng-Kung University Hospital