NCT06920953

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

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%

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: B. Braun Ltd. Centre of Excellence Infection Control · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Catheter Associated Urinary Tract Infection

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2025-04-10
• Last updated: 2025-04-10