Trial Outcomes & Findings for Comparison of Two Intermittent Urinary Catheters (NCT NCT01284361)

NCT ID: NCT01284361

Last Updated: 2017-02-01

Results Overview

Percentage of participants that preferred the 40 cm catheter

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 91 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2017-02-01

Participant Flow

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

Participant milestones

Measure	Control and Test Crossover test and control intermittent urinary catheters : randomized cross-over
Overall Study STARTED	91
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Control and Test Crossover test and control intermittent urinary catheters : randomized cross-over
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	5
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Comparison of Two Intermittent Urinary Catheters

Baseline characteristics by cohort

Measure	Control and Test Crossover n=82 Participants test and control intermittent urinary catheters : randomized cross-over
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.3 years STANDARD_DEVIATION 11.7 • n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	82 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Percentage of participants that preferred the 40 cm catheter

Outcome measures

Measure	Control and Test Crossover n=82 Participants Control and test intermittent urinary catheters : randomized cross-over	Test 30 cm Catheter Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
Percentage of Participants	91.5 percentage of participants	—

SECONDARY outcome

Timeframe: 1 week

Population: 82 self-catheterizing wheelchair-using men

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.

Outcome measures

Measure	Control and Test Crossover n=82 Participants Control and test intermittent urinary catheters : randomized cross-over	Test 30 cm Catheter n=82 Participants Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
Assessment of Ease of Use Characteristics Ease of insertion	84.65 percentage of participants	67.78 percentage of participants
Assessment of Ease of Use Characteristics Ease of Removal	94.85 percentage of participants	86.34 percentage of participants
Assessment of Ease of Use Characteristics Ease of Catheter Control Upon Urethral Insertion	86.48 percentage of participants	72.19 percentage of participants
Assessment of Ease of Use Characteristics Confidence of Complete Bladder Drainage	84.15 percentage of participants	45.80 percentage of participants
Assessment of Ease of Use Characteristics Ease of Draining into Receptacle	87.00 percentage of participants	58.02 percentage of participants
Assessment of Ease of Use Characteristics Ease of Connecting Urine Bag	35.68 percentage of participants	31.49 percentage of participants

Adverse Events

Control 40 cm Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test 30 cm Catheter

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control 40 cm Catheter n=91 participants at risk Commercial 40 cm gel lubricated catheter	Test 30 cm Catheter n=91 participants at risk Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
Renal and urinary disorders bleeding	0.00% 0/91	1.1% 1/91 • Number of events 91
Renal and urinary disorders discomfort	0.00% 0/91	1.1% 1/91 • Number of events 91

Additional Information

Malford Cullum PhD/Sr Clin Res Scientist

Hollister Incorporated

Phone: 847-918-3975

Email: malford.cullum@hollister.com

Results disclosure agreements

• Principal investigator is a sponsor employee Variable restriction depends on site.
• Publication restrictions are in place

Restriction type: OTHER