About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age younger than 18 years
Intermittent self catheterisation
Pregnant or contemplating pregnancy or breastfeeding
Ongoing S-CAUTI (until treatment is complete)
Trial population
Adults (≥ 18 years) living in the community with urethral or suprapubic long-term (\> 28 days) catheter (LTC) and currently undertaking Uro-Tainer® Polihexanide 0.02 % washouts
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Long-Term-Catheter participant satisfaction with their washout policy
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'.
Secondary outcomes
Impact of washouts on participants QoL
Quality of Life assessed on ICIQ-LTCqol 12/12 (disease specific questionnaire), including * eight questions to the topic "Catheter function and concern", and to each question a VAS "How much does this bother you", with a value from 0 (= overall good) to 10 (= overall bad), * three questions to the topic "Lifestyle impact", and * four unscored questions, and to each question a VAS "How much does this bother you", with a value from 0 (= overall good) to 10 (= overall bad).
Impact of washouts on state of health
Quality of Life assessed with the questionnaire EQ-5D-5L, including fife questions, and EQ-5D-VAS "How good or bad your health is TODAY?", with a value from 0 (= The worst health you can imagine) to 100 (= The best health you can imagine.)
Adverse events: Long-Term-Catheter (LTC) blockage requiring an intervention; symptomatic LTC-related urinary tract infections (S-CAUTI)
Lont-Term-Catheter washouts diary
Locations
Sponsors and contacts
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