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

Erasmus MC0 个研究点目标入组 456 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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

•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

发起方