Comparison of Two Intermittent Urinary Catheters

Urinary Retention Clinical Trial

Official title:

User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284361
• Other study ID #: 4875-I
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: October 17, 2013
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2012
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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/Charriere 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Device:
• test and control intermittent urinary catheters
randomized cross-over

Locations

Country	Name	City	State
United States	Shepherd Center and Crawford Research Institute	Atlanta	Georgia
United States	Restored Images	Kansas City	Missouri
United States	Vanderbilt University	Nashville	Tennessee
United States	Mark Drug Medical Supply	Wheeling	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preference for length	proportion of subjects favoring one length over the other	1 week	No
Secondary	appreciation of user characteristics	ease of insertion, removal, and control while catheterizing rated using a 5 point Likert scale	1 week	No