Status:
NOT_YET_RECRUITING
Participant Satisfaction and Quality of Life With Catheter Washouts in Adults Living With Long-Term Catheters and Currently Using Uro-Tainer® Polihexanide 0.02%
Lead Sponsor:
B. Braun Ltd. Centre of Excellence Infection Control
Conditions:
Catheter Associated Urinary Tract Infection
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06920953
Start Date
May 1 2025
End Date
February 28 2026
Last Update
April 10 2025
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