Trial Outcomes & Findings for Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers (NCT NCT01142115)

NCT ID: NCT01142115

Last Updated: 2011-10-07

Results Overview

Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
• Results posted on: 2011-10-07

Participant Flow

January-May, 2010, Department of Urology, Rigshospitalet, Denmark

Participant milestones

Measure	SpeediCath First, Then Monza Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.	Monza First, Then SpeediCath Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
First Intervention STARTED	21	20
First Intervention COMPLETED	19	19
First Intervention NOT COMPLETED	2	1
Second Intervention STARTED	19	19
Second Intervention COMPLETED	19	19
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	SpeediCath First, Then Monza Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.	Monza First, Then SpeediCath Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
First Intervention Lack of Efficacy	1	1
First Intervention Adverse Event	1	0

Baseline Characteristics

Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

Baseline characteristics by cohort

Measure	Entire Study Population n=41 Participants Includes groups randomized to receive SpeediCath first and Monza first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	25.9 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment Denmark	41 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1

Population: Intention to Treat (ITT) population

Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).

Outcome measures

Measure	Monza n=38 Participants Test product	SpeediCath n=39 Participants Control Product
Discomfort Measured on the Visual Analog Scale (VAS)	3.7 cm Standard Deviation 2.2	2.6 cm Standard Deviation 1.8

SECONDARY outcome

Timeframe: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

Population: ITT

After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.

Yes - they experienced irritation. No - they did not experience irritation.

Outcome measures

Measure	Monza n=38 Participants Test product	SpeediCath n=39 Participants Control Product
Irritation During Voiding After Catheterization Answer "No"	17 Participants	32 Participants
Irritation During Voiding After Catheterization Answer "Yes"	21 Participants	7 Participants

SECONDARY outcome

Timeframe: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

Population: ITT

After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.

There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy

Outcome measures

Measure	Monza n=38 Participants Test product	SpeediCath n=39 Participants Control Product
Ease of Use Measured on a 5 Point Scale: Insertion Effort Answer "Very Difficult"	1 participants	0 participants
Ease of Use Measured on a 5 Point Scale: Insertion Effort Answer "Very Easy"	2 participants	7 participants
Ease of Use Measured on a 5 Point Scale: Insertion Effort Answer "Easy"	16 participants	20 participants
Ease of Use Measured on a 5 Point Scale: Insertion Effort Answer "Neither easy nor difficult"	13 participants	8 participants
Ease of Use Measured on a 5 Point Scale: Insertion Effort Answer "Difficult"	6 participants	4 participants

SECONDARY outcome

Timeframe: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

Population: ITT

After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.

There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy

Outcome measures

Measure	Monza n=38 Participants Test product	SpeediCath n=39 Participants Control Product
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort Answer "Easy"	10 participants	11 participants
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort Answer "Very Easy"	28 participants 0.45	28 participants 0.46
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort Answer "Neither easy nor difficult"	0 participants	0 participants
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort Answer "Difficult"	0 participants	0 participants
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort Answer "Very difficult"	0 participants	0 participants

SECONDARY outcome

Timeframe: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1

Population: ITT

Visual blood observed on the catheter or in the urine in connection to catheterization.

The nurse who conducted the catheterization could answer yes or no as follows:

Yes = visible blood observed. No = no visible blood observed.

Outcome measures

Measure	Monza n=38 Participants Test product	SpeediCath n=39 Participants Control Product
Visible Blood Visible blood	3 participants	1 participants
Visible Blood No visible blood	35 participants	38 participants

SECONDARY outcome

Timeframe: 2 hours after catheterisation at visits 1 and 2

Population: ITT

Negative or positive result on a multistix urin analysis.

Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.

Outcome measures

Measure	Monza n=38 Participants Test product	SpeediCath n=39 Participants Control Product
Haematuria Positive for haematuria	10 participants	9 participants
Haematuria Negative for haematuria	28 participants	30 participants

Adverse Events

Entire Study Population

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Entire Study Population n=41 participants at risk Includes groups randomized to receive SpeediCath first and Monza first
Renal and urinary disorders Urinary Tract Infection	2.4% 1/41 • Number of events 1

Additional Information

Trine Møller Kruse

Clinical Regulatory Development, Global R&D

Phone: +4549112174

Email: dktrm@coloplast.com

Results disclosure agreements

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

Restriction type: OTHER