Participant Satisfaction and Quality of Life With Catheter Washouts in Adults Living With Long-Te⦠(NCT06920953) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Participant Satisfaction and Quality of Life With Catheter Washouts in Adults Living With Long-Term Catheters and Currently Using Uro-TainerĀ® Polihexanide 0.02%
50 participantsStarted 2025-05-01
Plain-language summary
Uro-TainerĀ® 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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-TainerĀ® 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
Exclusion Criteria:
* 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,ā¦
What they're measuring
1
Long-Term-Catheter participant satisfaction with their washout policy
Timeframe: At the end of the study (day 84)
Trial details
NCT IDNCT06920953
SponsorB. Braun Ltd. Centre of Excellence Infection Control