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Clinical Trials/NL-OMON19999
NL-OMON19999RecruitingNot Applicable

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

Erasmus MC0 sites456 target enrollmentStarted: TBDLast updated:
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

Sponsor
Erasmus MC

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