Comparison of Two Intermittent Urinary Catheters

Hollister

Status: Completed

Conditions: Urinary Retention

Treatments: Device: 40 cm Intermittent Catheter; Device: 30 cm Intermittent Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284361

4875-I

Details and patient eligibility

About

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.

Full description

1. is male and at least 18 years of age.
2. is self-catheterizing at least 3 times a day.
3. has been performing catheterizations for at least 2 months.
4. is wheelchair bound.
5. is able to use a size 12 or 14 French straight catheter.
6. is willing and able to follow the study protocol and Investigator's instructions.
7. is in the opinion of the Investigator, qualified to participate.

Enrollment: 91 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

91 participants in 2 patient groups

30 cm Intermittent Catheter

Experimental group

Description:

Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design.

Treatment:

Device: 30 cm Intermittent Catheter

40 cm Intermittent Catheter

Active Comparator group

Description:

Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.

Treatment:

Device: 40 cm Intermittent Catheter