inability of bladder emptying Urinary retention
Conditions
Interventions
 
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. 
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 64 Years
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 prevents 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 primary outcome is symptomatic urinary tract infections (UTIs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be other adverse events, like hospital stays due to UTIs, bladder stones and haematuria, and symptom specific and quality of life questionnaires. Quality of life will be measured by the following validated questionnaires: EQ-5D-5L and an adjusted (shortened) version of the ICIQ-UAB questionnaire. The ease of use of the catheters will be evaluated by the Patient Global Impression of Improvement (PGI-I) scale, the ISCQ and the InCaSaQ. Cost-effectiveness calculation on both types of catheters will be made. The economic evaluation will be done using the iMCQ and iPCQ questionnaires. Two additional questions concerning patients thoughts on environmental burden and healthcare costs will be asked at week 0 and week 52. | — |
Countries
Netherlands
Contacts
Public ContactCHH Christiaans
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed