Chronic urinary retention is a common lower urinary tract disorder, mostly neurogenic or idiopathic in origin. The preferred treatment is clean intermittent urinary self-catheterisation (CISC) four to six times a day. In most European countries, virtually all patients use single use catheters, which is in contrast to several countries where the use of reusable catheters is more common. The available literature on the use of reusable catheters is conflicting and until now, no randomised controlled trial with sufficient power has been performed to investigate if reusable catheters for CISC is as safe as single use catheters.
We described this protocol for a prospective, randomised controlled non-inferiority trial to investigate if the use of reusable catheters is as safe as single use catheters for CISC patients, measured by symptomatic urinary tract infections (sUTIs). Secondary objectives are adverse events due to a sUTI, urethral damage, stone formation, quality of life and patient satisfaction. A cost-effectiveness analysis will also be performed. 456 Participants will be randomised into two groups stratified for age, gender, menopausal status and (non-)neurogenic underlying disorder. The intervention group will replace the reusable catheter set every 2 weeks for a new set and replace the cleaning solution every 24 hours. The control group continues to use its own catheters. The primary outcome (amount of sUTIs from baseline to 1 year) will be tested for non-inferiority. Categorical outcome measures will be analysed using χ2 tests and quantitative outcome variables by t-tests or Mann-Whitney U tests. Two-sided p values will be calculated.
This protocol was reviewed and approved by the Medical Ethics Committee of the Erasmus MC (MEC 2019-0134) and will be performed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for non-inferiority trials. The results of this randomised controlled non-inferiority trial will be published in a peer-reviewed journal and will be publicly available.
NL8296.
BMJ open. 2022 Apr 11*** epublish ***
Tess van Doorn, Sophie A Berendsen, Jeroen R Scheepe, Bertil F M Blok
Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands., Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands .