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

Recruiting

Conditions: inability of bladder emptying
Urinary retention
10046590

Registration Number: NL-OMON54700

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 386

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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is symptomatic urinary tract infections (UTIs).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be other adverse events, like hospital stays due to<br /><br>UTIs, bladder stones and haematuria, and symptom specific and quality of life<br /><br>questionnaires. Quality of life will be measured by the following validated<br /><br>questionnaires: EQ-5D-5L and an adjusted (shortened) version of the ICIQ-UAB<br /><br>questionnaire. The ease of use of the catheters will be evaluated by the<br /><br>Patient Global Impression of Improvement (PGI-I) scale, the ISCQ and the<br /><br>InCaSaQ. Cost-effectiveness calculation on both types of catheters will be<br /><br>made. The economic evaluation will be done using the iMCQ and iPCQ<br /><br>questionnaires. Two additional questions concerning patients thoughts on<br /><br>environmental burden and healthcare costs will be asked at week 0 and week 52.</p><br>