Single use vs reusable catheters in intermittent CatheterizatiOn for treatment of urinary retention: a Multicenter, Prospective, RandomizEd controlled, non-inferiority trial (COMPaRE)

OBJECTIVES/RESEARCH QUESTION(S): Clean intermittent catheterization (CIC) is the treatment of choice for patients suffering from idiopathic or neurogenic urinary retention, for example due to an enlarged prostate, pelvic surgery, spinal cord injury (SCI) or multiple sclerosis (MS). Most patients on CIC catheterize four to six times a day, keeping the catheterized volume preferably below 400-500 ml. Virtually all patients on CIC in the Netherlands utilize single use (=disposable) catheters, which is in contrast to the practice of the use of reusable catheters in many non-European countries. Possibly, this difference in practice is caused by observations that suggested that disposable catheters are less associated with urinary tract infections and other complications. Furthermore, the prevalence of reusable urinary catheters for CIC might be driven by restrains in healthcare budget. In this context, it is relevant to note that the global urinary catheter market size was valued in 2015 at USD 3.4 billion, with gradual grow in future perspective. This market is formed for around 60% by intermittent disposable catheters. The available literature on the differences in safety and efficacy between single use and reusable catheters is conflicting. On the one hand, it has been suggested that reuse of catheters introduces unwanted bacteria contamination and therefore increases the risk of symptomatic urinary infections and other complications, like stone formation and urethral strictures. On the other hand, limited evidence in patients on CIC suggest that reusable catheters are not less safe and not less effective as disposable catheters. The research question of this study will be: ‘Is the use of reusable catheters in patients on intermittent catheterization in urinary retention not less safe or not less efficient as the use of single use catheters?’ The study will be done in patients on CIC in a multicenter, prospective, randomized controlled, non-inferiority trial. The patients on CIC will be assigned to either single use or multi use catheterization during six months with the primary outcome ‘the amount of symptomatic UTIs’. The total duration of the project is 36 months. The potential effects on the health economics will be provided. HYPOTHESIS: The hypothesis of this study is that reusable catheters are not less safe and not less effective as single use catheters. STUDY DESIGN: The study will be set up as a multicenter, prospective, randomized controlled, non-inferiority trial. Patients will be randomized into two groups, one group will be assigned to the use of reusable catheters, the control group will use the single-use catheters. STUDY POPULATION AND SAMPLE SIZE Patients who self-catheterize and meet up to the inclusion criteria. The patients will be screened, included and randomized at the outpatient clinic of the participating hospital departments Sample size: a total of 456 patients are needed to be included. TYPE OF DEVICE: Catheters used for intermittent catheterization that are disposable and already reimbursed by standard health insurance in the Netherlands. The choice of the single use catheter will be determined by the preference of the patient. In this trail, the reusable catheter will be reused for a period of two weeks. USUAL CARE /COMPARISON: Currently the catheters used for intermittent catheterization in the Netherlands are used once and then thrown away. As mentioned above, often the type of disposable catheter is determined by the preference of the patients who are advised in their choice by the continence nurse. OUTCOME MEASURES: The primary outcome is symptomatic urinary tract infections (UTIs) UTIs. Secondary outcomes will be other adverse events, like hospital stays due to UTIs, bladder stones and hematuria, and symptom specific and quality of life questionnaires. Quality of life will be measured by the following questionnaires: Qualiveen-SF, MSISQ-15, UDI-6, ICIQ-7 and EQoL-5. The ease of use of the catheters will be evaluated by the Patient Global Impression of Improvement (PGI-I) scale and a cost-effectiveness calculation on both types of catheters will be made. ECONOMIC EVALUATION: This evaluation will be done in cooperation with the health economic in our projectgroup, using the iMCQ and iPCQ questionnaires and the EC-5D-5L measure method. TIME SCHEDULE: The study protocol is expected to be offered to the local Ethical Committee in October 2018. Inclusion of patients is expected to start in December 2018. We expect that the calculated sample size of patients is reached within 18 months. Patients will be in the initial study for six months. Thereafter, data is analyzed, validated and implementation for practice will be formed.