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

NCT06920953 | Not Yet Recruiting

• 1 other identifier: BA-O-H-24092
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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-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.

Conditions

Catheter Associated Urinary Tract Infection

Keywords

Catheter Washouts; Suprapubic long-term catheter

Outcome Measures

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'.

  At the end of the study (day 84)

Secondary Outcomes (3)

• Impact of washouts on participants QoL

  At two visits (day 1 and day 84)

• Impact of washouts on state of health

  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)

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Ltd. Centre of Excellence Infection Control: lead

Central Study Contacts

Thomas Frei, Bachelor

CONTACT

0798432644; thomas.frei@bbraun.com

Joerg Brechbuehl, Dr

CONTACT

0792382082; joerg.brechbuehl@bbraun.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 10, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share