Comparison of Two Intermittent Urinary Catheters

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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. is 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.

Official Title
-----------------
User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter

Conditions
-----------------
Urinary Retention

Intervention / Treatment
-----------------
* Device: 30 cm Intermittent Catheter
* Device: 40 cm Intermittent Catheter


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 cm Intermittent Catheter<br>Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design. | Device: 30 cm Intermittent Catheter<br>* Randomized cross-over<br>* Other names: Apogee Intermittent Catheter;|
| Active Comparator: 40 cm Intermittent Catheter<br>Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design. | Device: 40 cm Intermittent Catheter<br>* randomized cross-over<br>* Other names: Apogee Intermittent Catheter;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants | Percentage of participants that preferred the 40 cm catheter | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Ease of Use Characteristics | Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the top two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intermittent catheter, preference