A Prospective Observational Study to Evaluate Participant Satisfaction and Quality of Life With Catheter Washouts in Adults Living With Long-Term Catheters and Currently Using Uro-Tainer® Polihexanide 0.02%
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Long-Term-Catheter participant satisfaction with their washout policy
研究概览
简要总结
Uro-Tainer® Polihexanide 0.02% (acronym: UTP washout) is a sterile, single-use, water-based solution (100 ml) currently used in clinical practice in the UK (and Europe) for the irrigation of Long-Term-Catheter. This medical device is intended for the maintenance of indwelling urethral and suprapubic Long-Term-Catheter to aid removal of deposits, tissue waste, clots, and mucus.
In this study of people living with Long-Term-Catheter and currently using UTP washouts as part of their standard clinical care, the following will be investigated :
- Participant satisfaction with their UTP washout
- Impact of UTP washout plan on their QoL
- Adverse events (blockage, SCAUTI, others)
- Participant adherence to their current washout frequency plan. This is an observational study. The participants are those currently using UTP washouts as prescribed by their clinical care team. There will be no change in treatment for study purposes.
详细描述
Several Long-Term-Catheter (LTC) washouts policies and maintenance solutions are used in clinical practice for prevention and/or management of LTC adverse events. Washouts used are of different types (normal saline, acidic, antimicrobial); volumes (50 ml, 2 x 30 ml, and 100 ml) and frequency of administration. The recent Cochrane review assessed the best available evidence and found insufficient evidence to determine whether prophylactic LTC washout policies had a beneficial or harmful effect on any of the outcomes in participants with LTC.
Most recently the CATHETER II RCT in the UK faced difficulties in recruitment and was terminated with 80 participants (target was 600). The RCT compared a policy of weekly prophylactic washout using either saline or acidic washouts to no washout policy. Despite the small sample size, there were trends towards lower rates of blockage and S-CAUTI in the groups using prophylactic washouts. The results did not reach statistical significance possibly due to the small sample size.
In-addition to the mechanical benefit of washouts such as the saline, antimicrobial washout solutions aim to reduce or prevent bacterial growth and reduce LTC blockages.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Male or female aged 18 years
- •Participant is having a urethral or suprapubic long-term catheter (LTC) in situ for more than 28 days and no plan for discontinuation of LTC at the time of recruitment
- •Currently using the LTC washout maintenance solution Uro-Tainer® Polihexanide 0.02%
- •Able to undertake LTC washouts or has a designated person (relative, friend, other informal carer, or paid/NHS healthcare worker) able to perform washouts
- •Able to complete the study documentation or has a designated person able to assist with study documentation
- •Informed consent obtained
排除标准
- •Age younger than 18 years
- •Intermittent self catheterisation
- •Pregnant or contemplating pregnancy or breastfeeding
- •Ongoing S-CAUTI (until treatment is complete)
- •Visible haematuria (unless investigated/treated)
- •Known allergies to the LTC washout solution
- •Current bladder cancer (until treatment is complete and participant discharged from cancer surveillance program)
- •Known bladder stones (until treatment is complete)
- •Not able to communicate or to give consent including participants with incapacity to consent
- •Any other clinical and social reasons that would be deemed by the recruitment team to be unsuitable for the study
- •Simultaneous participation in another clinical trial
- •in case of hypersensitivity (allergy) to PHMB, chlorhexidine, or excipient of the solution.
- •several days after surgery on the bladder or the urinary tract
- •for open wounds, the inner and middle ear, the central nervous systems, eyes, hyaline cartilage, and meninges
结局指标
主要结局
Long-Term-Catheter participant satisfaction with their washout policy
时间窗: At the end of the study (day 84)
The participants' satisfaction with their washout is rated on the visual analogue scale "Participants" satisfaction with their washout solution - Uro-Tainer® Polihexanide 0.02%', with a minimum value of '0' and a maximum value of '10'. The minimum value means 'Not satisfied', the maximum value means 'Very satisfied'.
次要结局
- Impact of washouts on participants QoL(At two visits (day 1 and day 84))
- Impact of washouts on state of health(At two visits (day 1 and day 84))
- Adverse events: Long-Term-Catheter (LTC) blockage requiring an intervention; symptomatic LTC-related urinary tract infections (S-CAUTI)(At each visit (1-5), day 1 (baseline), day 21, day 42, day 63 and day 84 (close-out visit), and continuously between the visits, if an adverse event is reported by the participant.)