N/A
Completed N=91
Comparison of Two Intermittent Urinary Catheters
Urinary Retention
Source: ClinicalTrials.gov NCT01284361 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants — 91.5 percentage of participants
Summary
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants |
91.5 | — |
| SECONDARY Assessment of Ease of Use Characteristics |
84.65; 67.78; 94.85; 86.34; 86.48; 72.19 | — |
Eligibility Criteria
Inclusion Criteria
- is male and at least 18 years of age
- is self-catheterizing at least 3 times a day
- has been performing catheterizations for at least 2 months
- wheelchair bound
- is able to use a size 12 or 14 French straight catheter
- is willing and able to follow the study protocol and Investigator's instructions
- is, in the opinion of the Investigator, qualified to participate
Exclusion Criteria
- has cognitive impairments that preclude completion of study protocol
- cannot communicate as determined by the Investigator
- has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
- has a symptomatic urinary tract infection determined by interview
- has a retracted penis
- has participated in a study during the previous 30 days involving catheterization
- has been diagnosed with an enlarged prostate
- has urethral strictures, false passages, or urethral obstruction
Data sourced from ClinicalTrials.gov (NCT01284361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.