NL-OMON19999RecruitingNot Applicable
Single use vs reusable catheters in intermittent CatheterizatiOn for treatment of urinary retention: a Multicenter, Prospective, RandomizEd controlled, non-inferiority trial.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Erasmus MC
- Enrollment
- 456
Study Overview
Brief Summary
/A
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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