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-Tainer® Polihexanide 0.02%
50 participantsStarted 2025-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-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
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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