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

Clean intermittent catheterization (CIC) is the treatment of choice for patients suffering from non-neurogenic (idiopathic) or neurogenic urinary retention. Idiopathic retention is associated with over distension of the bladder after spinal or general surgery, bladder obstruction by enlarged prostate, pelvic surgery, but in most patients no cause is found. Spinal cord injury (SCI) and multiple sclerosis (MS) are important causes of neurogenic retention. Most patients catheterize four to six times a day, keeping the catheterized volume preferably below 400-500 ml. Virtually all patients on CIC in Europe utilize single use (=disposable) catheters, which is in contrast to the practice of the use of reusable catheters in many non-European countries. 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 study will be performed in patients on CIC in a multicenter, prospective, randomized controlled, non-inferiority trial. The participants will be assigned to either single use or reuse catheterization during twelve months follow-up.
The main objective of this trial is to determine whether reusable catheters are not less safe as single use catheters, measured by symptomatic UTIs. Secondary objectives are adverse events like hospital admissions due to UTIs, changes in urine cultures, urethral damage/strictures, kidney/bladder stone formation and quality of life of the participants. Cost effectiveness and recommendations for practice will be provided.

The hypothesis of this trial is that reusable catheters are as safe and efficient as single use catheters and will be cost-effective.

Time of inclusion: 18 months
Time of follow-up: 12 months consisting of 4 clinical visits where urine samples will be obtained and 5 telephone calls.

Half of the participants will start using the reusable catheter after randomization. This catheter is developed for reuse and will be used for two weeks. The catheter will be stored in a container filled with a cleaning substance, which will be renewed every 24 hours. The control group will remain using their single use catheter. All participants will be followed for 12 months.