CATHETER II: a 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

Mohammed Abdel-Fattah* (Corresponding Author), Muhammad Imran Omar, Diana Johnson, David Cooper, Lynda Constable, Sheela Tripathee, Sara MacLennan, Konstantinos Dimitropoulos, Suzanne Evans, Paraskeve Granitsiotis, Hashim Hashim, Mary Kilonzo, James Larcombe, Paul Little, Peter Murchie, Phyo Kyaw Myint, James N'Dow, Catherine Paterson, Karen Powell, Graham ScotlandNikesh Thiruchelvam, Amanda J Young, Seonaidh Cotton, John Norrie, Graeme MacLennan

*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Objectives Do weekly prophylactic saline or acidic catheter washouts in addition to standard long-term catheter (LTC) care improve the outcomes of adults with LTC compared with standard LTC care only.

Design Three-arm superiority open-label randomised controlled trial.

Setting UK community-based study.

Participants 80 adults with LTC (any type/route) ≥28 days in situ with no plans to discontinue and able to self-manage the washouts/study documentation with/without a carer.

Interventions Randomly allocated (26:27:27) to receive standard LTC care with weekly saline or weekly acidic or no prophylactic washouts for up to 24 months.

Primary and secondary outcome measures The primary outcome was catheter blockage requiring intervention (per 1000 catheter days). Secondary outcomes were symptomatic catheter-associated urinary tract infection (S-CAUTI) requiring antibiotics, adverse events, participants’ quality of life and day-to-day activities, acceptability and adherence.

Results Outcomes reported for 25 saline, 27 acidic and 26 control participants. LTC blockages (per 1000 catheter days) requiring treatment were 9.96, 10.53 and 20.92 in the saline, acidic and control groups, respectively. The incident rate ratio (IRR) favours the washout groups (saline 0.65 (97.5% CI 0.24 to 1.77); p=0.33 and acidic 0.59 (97.5% CI 0.22 to 1.63); p=0.25), although not statistically significant. The S-CAUTI rate (per 1000 catheter days) was 3.71, 6.72 and 8.05 in the saline, acidic and control groups, respectively. The IRR favours the saline group (saline 0.40 (97.5% CI 0.20 to 0.80); p=0.003 and acidic 0.98 (97.5% CI 0.54 to 1.78); p=0.93). The trial closed before reaching target recruitment due to reduced research capacity during the COVID-19 pandemic.

Conclusions Early closure and small sample size limits our ability to provide a definite answer. However, the observed non-statistically significant differences over control are favourable for lower rates of LTC blockages without a concomitant rise in S-CAUTI. The results support a multinational randomised controlled trial of catheter washouts in patients with LTC to ascertain their clinical and cost-effectiveness.
Original languageEnglish
Article numbere087203
Number of pages14
JournalBMJ Open
Volume14
Issue number12
Early online date2 Dec 2024
DOIs
Publication statusPublished - 2 Dec 2024

Data Availability Statement

Data are available on reasonable request. A request to access the datasets generated during the trial should be directed in the first instance to the corresponding author (Professor Mohamed Abdel-fattah, [email protected]). The datasets collected in questionnaires at all timepoints and the baseline, monthly and serious adverse event case report forms for all 80 participants recruited to the trial are available. The dataset is available in fully anonymised electronic form, at an individual level and in accordance with participant consent. The data dictionaries, study protocol, statistical analysis plan, patient information leaflets and template case report forms are also available on request to facilitate interpretation of data. Questionnaire templates, or parts thereof, may be available pending review of the relevant licensing agreements. Data for the study are currently available within a local repository at the University of Aberdeen and will be retained for a period of at least 10 years after close of trial in accordance with funder, sponsor and local archiving procedures. Applicants will require to complete a data request form that will be reviewed by a Data Sharing Committee, which includes the Chief Investigator. Applications will be considered on a case-by-case basis from bonafide researchers. We are obligated to ensure that optimal use is made of the data that are collected for research and we recognise the value of sharing individual-level data. The interests of research participants, researchers and other stakeholders will be considered when considering each application. A fully authorised data sharing agreement will be required prior to the release of data.

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  • Abdel-fattah_BMJO_CatheterII_A_Randomised_VoR

    © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    Final published version, 1.44 MBLicence: CC BY

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