Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial
Introduction Evaluating the safety and acceptability of reusing catheters for intermittent catheterisation (IC) is one of the top 10 continence research priorities identified by the UK James Lind Alliance Priority Setting Partnership in 2008. There are an estimated 50 000 IC users in England and thi...
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BMJ Publishing Group
2024-08-01
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| author | Isabel Reading Jeremy Jones Gillian Watson Paul Little Michael Moore Carl R May Suzanne Hagen Doreen McClurg Karen Guerrero Jacqui Prieto Nina Wilson Carol Shields Mandy Fader Bridget Clancy Margaret Macaulay Thomas J Chadwick Brian S Buckley Rajvinder Khasriya Alaa Abouhajar Catherine P James Nicola Goudie Sylvia Dickson Miriam R Avery Jackie Broadbridge Alan Cottenden Cathy Murphy Anthony Timoney Sandra A Wilks |
| author_facet | Isabel Reading Jeremy Jones Gillian Watson Paul Little Michael Moore Carl R May Suzanne Hagen Doreen McClurg Karen Guerrero Jacqui Prieto Nina Wilson Carol Shields Mandy Fader Bridget Clancy Margaret Macaulay Thomas J Chadwick Brian S Buckley Rajvinder Khasriya Alaa Abouhajar Catherine P James Nicola Goudie Sylvia Dickson Miriam R Avery Jackie Broadbridge Alan Cottenden Cathy Murphy Anthony Timoney Sandra A Wilks |
| author_sort | Isabel Reading |
| collection | DOAJ |
| description | Introduction Evaluating the safety and acceptability of reusing catheters for intermittent catheterisation (IC) is one of the top 10 continence research priorities identified by the UK James Lind Alliance Priority Setting Partnership in 2008. There are an estimated 50 000 IC users in England and this number is rising. Globally, both single-use catheters (thrown away after use) and multi-use/reusable ones (cleaned between uses) are used. Using multi-use catheters as well as single-use ones (mixed-use) could bring benefits (eg, reducing plastic waste and patients never running out of catheters) and offer more choice to users. Evidence is needed that mixed-use is at least as safe and acceptable as using only single-use catheters.Methods The MultICath Trial is a non-inferiority randomised controlled trial involving 578 participants. The aim is to compare mixed-use catheter management with single-use catheter management over 12 months. Participants are randomised on a 1:1 basis to either mixed-use catheter management, which includes an evidence-based cleaning method for the multi-use catheters (intervention) or single-use catheter management (control). Following randomisation, participants are followed up for 12 months. The primary outcome is at least one episode of microbiologically confirmed symptomatic urinary tract infection with help-seeking or self-help behaviour over the 12-month follow-up period. Laboratory analysis of patient-initiated urine samples is blind. Secondary outcomes include antibiotic use, microhaematuria, visible blood on catheter/in urine, quality of life and health economics. A qualitative sub-study to examine participant experiences using mixed-use is included.Ethics and dissemination Ethical review was undertaken by South Central-Hampshire A Research Ethics Committee and favourable opinion was granted on 12 July 2019 (reference: 19/SC/0334). Written, informed consent to participate was obtained from all participants. Results will be disseminated in peer-reviewed publications, in the National Institute for Health and Care Research journal library and to participants and the public via a lay summary published on the trial website.Trial registration number ISRCTN42028483. |
| format | Article |
| id | doaj-art-3e2962596cd24d109aae3e5ba63b6f6b |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
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| spelling | doaj-art-3e2962596cd24d109aae3e5ba63b6f6b2025-08-20T01:58:24ZengBMJ Publishing GroupBMJ Open2044-60552024-08-0114810.1136/bmjopen-2024-088483Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trialIsabel Reading0Jeremy Jones1Gillian Watson2Paul Little3Michael Moore4Carl R May5Suzanne Hagen6Doreen McClurg7Karen Guerrero8Jacqui Prieto9Nina Wilson10Carol Shields11Mandy Fader12Bridget Clancy13Margaret Macaulay14Thomas J Chadwick15Brian S Buckley16Rajvinder Khasriya17Alaa Abouhajar18Catherine P James19Nicola Goudie20Sylvia Dickson21Miriam R Avery22Jackie Broadbridge23Alan Cottenden24Cathy Murphy25Anthony Timoney26Sandra A Wilks271 University of Southampton, Southampton, UK1 University of Southampton, Southampton, UK2 Newcastle University, Newcastle upon Tyne, UKPrimary Care Research Centre, University of Southampton, Southampton, UK1 University of Southampton, Southampton, UK7 London School of Hygiene and Tropical Medicine, London, UKprofessor of health services research5 Glasgow Caledonian University, Glasgow, UK6 Queen Elizabeth University Hospital, Glasgow, UK1 University of Southampton, Southampton, UK2 Newcastle University, Newcastle upon Tyne, UK2 Newcastle University, Newcastle upon Tyne, UK1 University of Southampton, Southampton, UK1 University of Southampton, Southampton, UK1 University of Southampton, Southampton, UK2 Newcastle University, Newcastle upon Tyne, UK3 University of the Philippines, Manila, Philippines4 University College London, London, UK2 Newcastle University, Newcastle upon Tyne, UK4 University College London, London, UK2 Newcastle University, Newcastle upon Tyne, UK5 Glasgow Caledonian University, Glasgow, UK1 University of Southampton, Southampton, UK1 University of Southampton, Southampton, UK4 University College London, London, UK1 University of Southampton, Southampton, UK8 Southmead Hospital, Bristol, UK1 University of Southampton, Southampton, UKIntroduction Evaluating the safety and acceptability of reusing catheters for intermittent catheterisation (IC) is one of the top 10 continence research priorities identified by the UK James Lind Alliance Priority Setting Partnership in 2008. There are an estimated 50 000 IC users in England and this number is rising. Globally, both single-use catheters (thrown away after use) and multi-use/reusable ones (cleaned between uses) are used. Using multi-use catheters as well as single-use ones (mixed-use) could bring benefits (eg, reducing plastic waste and patients never running out of catheters) and offer more choice to users. Evidence is needed that mixed-use is at least as safe and acceptable as using only single-use catheters.Methods The MultICath Trial is a non-inferiority randomised controlled trial involving 578 participants. The aim is to compare mixed-use catheter management with single-use catheter management over 12 months. Participants are randomised on a 1:1 basis to either mixed-use catheter management, which includes an evidence-based cleaning method for the multi-use catheters (intervention) or single-use catheter management (control). Following randomisation, participants are followed up for 12 months. The primary outcome is at least one episode of microbiologically confirmed symptomatic urinary tract infection with help-seeking or self-help behaviour over the 12-month follow-up period. Laboratory analysis of patient-initiated urine samples is blind. Secondary outcomes include antibiotic use, microhaematuria, visible blood on catheter/in urine, quality of life and health economics. A qualitative sub-study to examine participant experiences using mixed-use is included.Ethics and dissemination Ethical review was undertaken by South Central-Hampshire A Research Ethics Committee and favourable opinion was granted on 12 July 2019 (reference: 19/SC/0334). Written, informed consent to participate was obtained from all participants. Results will be disseminated in peer-reviewed publications, in the National Institute for Health and Care Research journal library and to participants and the public via a lay summary published on the trial website.Trial registration number ISRCTN42028483.https://bmjopen.bmj.com/content/14/8/e088483.full |
| spellingShingle | Isabel Reading Jeremy Jones Gillian Watson Paul Little Michael Moore Carl R May Suzanne Hagen Doreen McClurg Karen Guerrero Jacqui Prieto Nina Wilson Carol Shields Mandy Fader Bridget Clancy Margaret Macaulay Thomas J Chadwick Brian S Buckley Rajvinder Khasriya Alaa Abouhajar Catherine P James Nicola Goudie Sylvia Dickson Miriam R Avery Jackie Broadbridge Alan Cottenden Cathy Murphy Anthony Timoney Sandra A Wilks Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial BMJ Open |
| title | Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial |
| title_full | Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial |
| title_fullStr | Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial |
| title_full_unstemmed | Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial |
| title_short | Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial |
| title_sort | trial to compare mixed use multi use and single use intermittent catheter management with single use management over 12 months the multicath trial protocol for a non inferiority randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/8/e088483.full |
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