Participant Satisfaction and Quality of Life With Catheter Washouts in Adults Living With Long-Term Catheters and Currently Using Uro-Tainer® Polihexanide 0.02%

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorB. Braun Ltd. Centre of Excellence Infection Control

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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