Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Aug 4;23(1):630.
doi: 10.1186/s13063-022-06577-2.

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study

Mohamed Abdel-Fattah  1 , Diana Johnson  2 , Lynda Constable  2 , Ruth Thomas  2 , Seonaidh Cotton  2 , Sheela Tripathee  3 , David Cooper  4 , Sue Boran  5 , Konstantinos Dimitropoulos  3 , Suzanne Evans  6 , Paraskeve Granitsiotis  7 , Hashim Hashim  8 , Mary Kilonzo  9 , James Larcombe  10 , Paul Little  11 , Sara MacLennan  3 , Peter Murchie  12 , Phyo Kyaw Myint  13 , James N'Dow  3 , John Norrie  14 , Muhammad Imran Omar  3 , Catherine Paterson  15 , Graham Scotland  9 , Nikesh Thiruchelvam  16 , Graeme MacLennan  2
Affiliations

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study

Mohamed Abdel-Fattah et al. Trials. .

Abstract

Background: Various washout policies are widely used in adults living with long-term catheters (LTC). There is currently insufficient evidence on the benefits and potential harms of prophylactic LTC washout policies in the prevention of blockages and other LTC-related adverse events, such as urinary tract infections. CATHETER II tests the hypothesis that weekly prophylactic LTC washouts (normal saline or citric acid) in addition to standard LTC care reduce the incidence of catheter blockage requiring intervention compared to standard LTC care only in adults living with LTC.

Methods: CATHETER II is a pragmatic three-arm open multi-centre superiority randomised controlled trial with an internal pilot, economic analysis, and embedded qualitative study. Eligible participants are adults aged ≥ 18 years, who have had a LTC in use for ≥ 28 days, have no plans to discontinue the use of the catheter, are able to undertake the catheter washouts, and complete trial documentation or have a carer able to help them. Participants are identified from general practitioner practices, secondary/tertiary care, community healthcare, care homes, and via public advertising strategies. Participants are randomised 1:1:1 to receive a weekly saline (0.9%) washout in addition to standard LTC care, a weekly citric acid (3.23%) washout in addition to standard LTC care or standard LTC care only. Participants and/or carers will receive training to administer the washouts. Patient-reported outcomes are collected at baseline and for 24 months post-randomisation. The primary clinical outcome is catheter blockage requiring intervention up to 24 months post-randomisation expressed per 1000 catheter days. Secondary outcomes include symptomatic catheter-associated urinary tract infection requiring antibiotics, catheter change, adverse events, NHS/ healthcare use, and impact on quality of life.

Discussion: This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015).

Trial registration: ISRCTN ISRCTN17116445 . Registered prospectively on 06 November 2019.

Keywords: Catheter blockage; Catheter maintenance solutions; Catheter washout solutions; Indwelling catheter; Long-term catheter; Symptomatic catheter-associated urinary tract infection.

PubMed Disclaimer

Conflict of interest statement

The study is funded by the NIHR Health Technology Assessment. B. Braun Medical AG donated the supply of washout solutions for use in the CATHETER II study. B. Braun Medical AG had no role in the design of the study, collection of data and the writing of this paper and will not have a role in future collection and analysis and interpretation of the data. B.Braun Medical AG may comment on future manuscripts prior to submission, and these shall be considered so long as they do not compromise the scientific nature or neutrality of the publication. The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram describing the participant timeline through CATHETER II
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Wilde MH, McMahon JM, Crean HF, Brasch J. Exploring relationships of catheter-associated urinary tract infection and blockage in people with long-term indwelling urinary catheters. J Clin Nurs. 2017;26(17-18):2558–2571. doi: 10.1111/jocn.13626. - DOI - PMC - PubMed
    1. Shepherd AJ, Mackay WG, Hagen S. Washout policies in long-term indwelling urinary catheterisation in adults. Cochrane Database Syst Rev. 2017;3(3):CD004012. - PMC - PubMed
    1. National Institute for Health and Clinical Excellence (NICE). Healthcare-associated infections: prevention and control in primary and community care. 2017; Available at: www.nice.org.uk/guidance/cg139. Accessed 31 Mar 2021. - PubMed
    1. National Health Service. Urinary catheters. 2020; Available at: https://www.nhs.uk/conditions/urinary-catheters/. Accessed 11 Apr 2022.
    1. Wilde MH, Mcdonald MV, Brasch J, Mcmahon JM, Fairbanks E, Shah S, et al. Long-term urinary catheter users self-care practices and problems. J Clin Nurs. 2013;22(3-4):356–367. doi: 10.1111/jocn.12042. - DOI - PMC - PubMed

Publication types