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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Catheter Associated Urinary Tract Infection

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 (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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Thomas Frei, Bachelor; Phone Number: +41 0798432644; Email: thomas.frei@bbraun.com
• Study Contact Backup: Name: Joerg Brechbuehl, Dr; Phone Number: +41 0792382082; Email: joerg.brechbuehl@bbraun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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, the inner and middle ear, the central nervous systems, eyes, hyaline cartilage, and meninges

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.)	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	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Catheter Washouts; Suprapubic long-term catheter
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: BA-O-H-24092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No