UTP Washout Study

  • Research type

    Research Study

  • Full title

    A Prospective Observational Study to Evaluate Participant Satisfaction and Quality of Life with Catheter Washout in Adults Living with Long-Term Catheters and Currently Using Uro-Tainer® Polihexanide 0.02% (UTP WASHOUT)

  • IRAS ID

    356303

  • Contact name

    Thomas Frei

  • Contact email

    thomas.frei@bbraun.com

  • Sponsor organisation

    B. Braun Medical AG

  • Clinicaltrials.gov Identifier

    NCT06920953

  • Duration of Study in the UK

    0 years, 6 months, 18 days

  • Research summary

    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), and frequency of administration. The recent CATHETER II RCT showed potential benefit of a policy for prophylactic weekly catheter washout solutions (saline / acidic) in preventing blockages and catheter associated Urinary tract infections. However, the RCT was terminated early without reaching its target recruitment due to COVID pandemic [Abdel-fattah 2025].
    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 [NHS 2013].
    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 LTC. This maintenance solution for indwelling urethral and suprapubic LTC aim to aid removal of deposits, tissue waste, clots, and mucus.

    In this observational study of people living with LTC and currently using UTP washouts as part of their standard clinical care, we aim to address the following:
    - Participant satisfaction with their UTP washout and Impact of their washout plan on their QoL
    - Patient reported 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.

  • REC name

    North East - Tyne & Wear South Research Ethics Committee

  • REC reference

    25/NE/0098

  • Date of REC Opinion

    21 May 2025

  • REC opinion

    Favourable Opinion