Urinary retention due to non-neurogenic and neurogenic causes
Conditions
Interventions
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 fil
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Male/Female patients = 16 years old - Diagnosed with urinary retention or significant post-void residue due to non-neurogenic or neurogenic causes - Expected chronic, but at least for a duration of twelve months, necessity for daily drainage of the urinary bladder - Be able to administer self CIC via the urethra daily and have at least two weeks of experience in CIC
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age < 16 years - Temporary use of catheterization because of transient causes - Known significant urethral stricture which complicates CIC - Urinary tract stones - Bladder augmentation - Non-urethral catheterization - History of bladder cancer with active follow-up - The use of immunosuppressives for transplantation or auto-immune diseases - Neurocognitive disease which prevents complete comprehension of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary objectives are adverse events like hospital admissions due to UTIs, changes in urine cultures/urinary microbiome, urethral damage/strictures, kidney/bladder stone formation and quality of life of the participants. Cost effectiveness and recommendations for practice will be provided. | — |
Contacts
Public ContactBertil Blok
Erasmus Medical Center
Outcome results
None listed