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

Clean intermittent catheterization (CIC) is the treatment of choice for
patients suffering from idiopathic or neurogenic urinary retention. Possible
causes are enlarged prostate, pelvic surgery, spinal cord injury (SCI) or
multiple sclerosis (MS). Most patients 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. The main reason is that there exists thus far no CE
marked reusable catheter. Our group has found that a Japanese company owns the
CE mark and this will be used to introduce the reusable catheter in Europe. The
suppliers who make the single use catheters support all patient advocate and
continence nurse societies. The webpages of the industry suggests strongly that
disposable catheters are less associated with urinary tract infections and
other complications. 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
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 with in vitro experiments that reuse of catheters
introduces unwanted bacterial 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 potential effects on the Dutch health economics will be
provided. The project is supported by ZonMW (project 853001104 in the framework
of Goed Gebruik Hulpmiddelenzorg).

The main objective of this trial is to determine whether reusable catheters are
not less efficient as single use catheters, measured by symptomatic UTIs.
Secondary objectives are adverse events like hospital admissions due to UTIs,
urethral damage/strictures, kidney/bladder stone formation and quality of life
of the participants. Cost effectiveness and recommendations for practice will
be provided.

The study will be performed in patients who CIC in a multicenter, prospective,
randomized controlled, non-inferiority trial. The patients on CIC will be
assigned to either single use or reuse catheterization during 12 months with
the primary outcome "the amount of symptomatic UTIs". The total duration of
this trial is 36 months.

Patients will be randomized into two groups, one group will use the single use
catheters, the other group will start using the reusable catheter which will be
renewed every two weeks.

Patients will have an extension of two clinical visits at the hospital and
seven telephone contacts for follow up of the trial. The extra burden for
patients in the reusable catheter group is the cleaning procedure of the
catheter in which patients will be schooled. During the follow-up, patients are
asked to fill in the questionnaires four times.