An observational study in Catheter Associated Urinary Tract Infection, sponsored by B. Braun Ltd. Centre of Excellence Infection Control. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by B. Braun Ltd. Centre of Excellence Infection Control · Observational
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 :
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.
752 studies on the registry are indexed under Urinary Tract Infections; 127 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 188 observational studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →B. Braun Ltd. Centre of Excellence Infection Control is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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'.
Time frame: At the end of the study (day 84)
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).
Time frame: At two visits (day 1 and day 84)
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.)
Time frame: 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)
Lont-Term-Catheter washouts diary
Time frame: 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.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
B. Braun Ltd. Centre of Excellence Infection Control