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Trial Outcomes & Findings for A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study (NCT NCT00990093)

NCT ID: NCT00990093

Last Updated: 2012-09-05

Results Overview

Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

14 days

Results posted on

2012-09-05

Participant Flow

Participant milestones

Participant milestones
Measure
B: First Standard Catheter Then Test Catheter
Test catheter is a CH 12 hydrophilic coated intermittent catheter
A: First Test Catheter Then Standard Catheter
Test catheter is a CH 12 hydrophilic coated intermittent catheter
Test Period 1 (1-14 Days)
STARTED
17
19
Test Period 1 (1-14 Days)
COMPLETED
15
15
Test Period 1 (1-14 Days)
NOT COMPLETED
2
4
Test Period 2 (15-28 Days)
STARTED
15
15
Test Period 2 (15-28 Days)
COMPLETED
14
13
Test Period 2 (15-28 Days)
NOT COMPLETED
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
B: First Standard Catheter Then Test Catheter
Test catheter is a CH 12 hydrophilic coated intermittent catheter
A: First Test Catheter Then Standard Catheter
Test catheter is a CH 12 hydrophilic coated intermittent catheter
Test Period 1 (1-14 Days)
Adverse Event
0
1
Test Period 1 (1-14 Days)
Withdrawal by Subject
0
2
Test Period 1 (1-14 Days)
Other
0
1
Test Period 1 (1-14 Days)
Lack of Efficacy
2
0
Test Period 2 (15-28 Days)
Adverse Event
0
1
Test Period 2 (15-28 Days)
Lack of Efficacy
0
1
Test Period 2 (15-28 Days)
Other
1
0

Baseline Characteristics

A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=36 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
32 Participants
n=5 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
Age Continuous
43.2 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants
Region of Enrollment
Denmark
24 participants
n=5 Participants
Region of Enrollment
France
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.

Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)

Outcome measures

Outcome measures
Measure
Test Catheter
n=30 Participants
SpeediCath Compact Male Catheter
Standard Catheter
n=30 Participants
SpeediCath Catheter
Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
1.59 units on a scale
Standard Deviation 2.28
1.94 units on a scale
Standard Deviation 2.24

Adverse Events

Test Catheter

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Standard Catheter

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Test Catheter
n=32 participants at risk
SpeediCath Compact Male
Standard Catheter
n=34 participants at risk
SpeediCath, CH 12 hydrophilic coated intermittent catheter
Infections and infestations
epididymitis
0.00%
0/32
2.9%
1/34
Renal and urinary disorders
discomfort during insertion
3.1%
1/32
0.00%
0/34

Additional Information

Kristine Gjødsbøl, PhD

Coloplast

Phone: +4549113557

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60