Comparison of Two Intermittent Urinary Catheters

• Sponsor: Hollister Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01284361
• Collaborator: (none)
• Enrollment: 91
• Locations: 4
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 22.8
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Device: 30 cm Intermittent Catheter; Device: 40 cm Intermittent Catheter	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 30 cm Intermittent Catheter 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; Randomized cross-over; Other Names: Apogee Intermittent Catheter
Active Comparator: 40 cm Intermittent Catheter Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.	Device: 40 cm Intermittent Catheter; randomized cross-over; Other Names: Apogee Intermittent Catheter

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants [1 week]

   Percentage of participants that preferred the 40 cm catheter

Secondary Outcome Measures

1. Assessment of Ease of Use Characteristics [1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shepherd Center and Crawford Research Institute	Atlanta	Georgia	United States	30309-1465
2	Mark Drug Medical Supply	Wheeling	Illinois	United States	60090
3	Restored Images	Kansas City	Missouri	United States	64119
4	Vanderbilt University	Nashville	Tennessee	United States	37235

Sponsors and Collaborators

• Hollister Incorporated

Investigators

• Study Director: Rita Kaurs, MSHSA MT NMT, Hollister Incorporated

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization

Publications

None provided.

• Responsible Party: Hollister Incorporated
• ClinicalTrials.gov Identifier: NCT01284361
• Other Study ID Numbers: 4875-I
• First Posted: Jan 27, 2011
• Last Update Posted: Feb 1, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Hollister Incorporated: intermittent catheter; preference
• Additional relevant MeSH terms: Urinary Retention

Study Results

Participant Flow

Recruitment Details	Recruitment period: October 10, 2010 - July 21 , 2011 types of locations: private vendor, public rehabilitation center, university

Arm/Group Title	Control and Test Crossover
Arm/Group Description	test and control intermittent urinary catheters : randomized cross-over
Period Title: Overall Study
STARTED	91
COMPLETED	82
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Control and Test Crossover
Arm/Group Description	test and control intermittent urinary catheters : randomized cross-over
Overall Participants	82
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	82 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.3 (11.7)
Gender (Count of Participants)
Female	0 0%
Male	82 100%
Region of Enrollment (participants) [Number]
United States	82 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants
Description	Percentage of participants that preferred the 40 cm catheter
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control and Test Crossover
Arm/Group Description	Control and test intermittent urinary catheters : randomized cross-over
Measure Participants	82
Number [percentage of participants]	91.5 111.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control and Test Crossover
	Comments	The sample size of 81 subjects provides a 10.8% margin of error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Proportion
	Estimated Value	91.5
	Confidence Interval	(2-Sided) 95%; 84.5 to 97.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.

2. Secondary Outcome

Title	Assessment of Ease of Use Characteristics
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

82 self-catheterizing wheelchair-using men

Arm/Group Title	Control 40 cm Catheter	Test 30 cm Catheter
Arm/Group Description	Commercial gel lubricated 40 cm catheter	Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
Measure Participants	82	82
Ease of insertion	84.65 103.2%	67.78 NaN
Ease of Removal	94.85 115.7%	86.34 NaN
Ease of Catheter Control Upon Urethral Insertion	86.48 105.5%	72.19 NaN
Confidence of Complete Bladder Drainage	84.15 102.6%	45.80 NaN
Ease of Draining into Receptacle	87.00 106.1%	58.02 NaN
Ease of Connecting Urine Bag	35.68 43.5%	31.49 NaN

Adverse Events

Arm/Group Title	Control 40 cm Catheter		Test 30 cm Catheter
Arm/Group Description	Commercial 40 cm gel lubricated catheter		Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
All Cause Mortality
	Control 40 cm Catheter		Test 30 cm Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control 40 cm Catheter		Test 30 cm Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		0/91 (0%)
Other (Not Including Serious) Adverse Events
	Control 40 cm Catheter		Test 30 cm Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		2/91 (2.2%)
Renal and urinary disorders
bleeding	0/91 (0%)	0	1/91 (1.1%)	91
discomfort	0/91 (0%)	0	1/91 (1.1%)	91

Limitations/Caveats

Male catheter users only in USA only.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Variable restriction depends on site.