Trial Outcomes & Findings for Test Catheter Pilot Study in Healthy Volunteers (NCT NCT00832078)

NCT ID: NCT00832078

Last Updated: 2012-09-05

Results Overview

Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

After each catheterisation

Results posted on

2012-09-05

Participant Flow

28 participants enrolled in study. 2 were excluded before randomization as they did not comply with inclusion criteria. One was excluded from study (ITT) as participants dropped out before having any data recorded.

Participant milestones

Participant milestones
Measure	Group A Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant	Group B Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
Test Day 1- 1 Period STARTED	13	12
Test Day 1- 1 Period COMPLETED	13	12
Test Day 1- 1 Period NOT COMPLETED	0	0
Test Day 1-2 Period STARTED	13	12
Test Day 1-2 Period COMPLETED	13	10
Test Day 1-2 Period NOT COMPLETED	0	2
Test Day 2 - 1 Period STARTED	13	10
Test Day 2 - 1 Period COMPLETED	13	10
Test Day 2 - 1 Period NOT COMPLETED	0	0
Test Day 2 - 2 Period STARTED	13	10
Test Day 2 - 2 Period COMPLETED	12	10
Test Day 2 - 2 Period NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant	Group B Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
Test Day 1-2 Period Lack of Efficacy	0	2
Test Day 2 - 2 Period Lack of Efficacy	1	0

Baseline Characteristics

Test Catheter Pilot Study in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=25 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	27.3 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Denmark	25 participants n=5 Participants

PRIMARY outcome

Timeframe: After each catheterisation

Population: The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM)

Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)

Outcome measures

Outcome measures
Measure	Test Catheter SCCM n=23 Participants The Test catheter SpeediCath Compact Male (SCCM)	Standard Catheter SC n=25 Participants The Stanard catheter SpeediCath (SC)
Discomfort	2.25 units on a scale Standard Deviation 1.5	2.52 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: After each catheterisation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After each catheterisation

Outcome measures

Outcome data not reported

Adverse Events

Test Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scientific Manager

Coloplast

Phone: +4549113557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60