Evaluation of Residual Urine After Intermittent Catheterisation

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00324233
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief Summary

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Intermittent catheter; Device: Compact intermittent catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SC Speedicath (SC) catheter is a catheter for intermittent catherisation	Device: Intermittent catheter; SpeediCath catherter (SC) for intermittent catherisation
Experimental: SCCM SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males	Device: Compact intermittent catheter; SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

Outcome Measures

Primary Outcome Measures

1. Residual Urine Measured by Ultra Sound [2]

Secondary Outcome Measures

1. Subjectively Measured Handling []

2. Subjectively Measured Insertion of the Catheter []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male

• 18 years and above

• A negative urine dip-stick

• Have signed informed written consent to participate

Exclusion Criteria:

• The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen	København Ø	Denmark	2100

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Per Bagi, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT00324233
• Other Study ID Numbers: DK052CC
• First Posted: May 10, 2006
• Last Update Posted: Jan 1, 2013
• Last Verified: Nov 1, 2012

• Keywords provided by Coloplast A/S: Residual urine; Hematuria; Ultra sound

Study Results

Participant Flow

Arm/Group Title	SC Then SCCM	SCCM Then SC
Arm/Group Description	SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period	SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
Period Title: First Period
STARTED	18	18
COMPLETED	17	18
NOT COMPLETED	1	0
Period Title: First Period
STARTED	17	18
COMPLETED	12	11
NOT COMPLETED	5	7

Baseline Characteristics

Arm/Group Title	SC Then SCCM	SCCM Then SC	Total
Arm/Group Description	SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period	SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period	Total of all reporting groups
Overall Participants	18	18	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 100%	18 100%	36 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.6 (3.0)	23.9 (2.9)	23.7 (2.9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	18 100%	18 100%	36 100%
Region of Enrollment (participants) [Number]
Denmark	18 100%	18 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Residual Urine Measured by Ultra Sound
Time Frame	2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SpeediCath	SpediCath Compact Male
Arm/Group Description
Measure Participants	36	33
Mean (Standard Deviation) [ml]	11 (30)	6 (23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SpeediCath, SpediCath Compact Male
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	equivalence testing
	Comments

2. Secondary Outcome

Title	Subjectively Measured Handling

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Subjectively Measured Insertion of the Catheter

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	SC Then SCCM		SCCM Then SC
Arm/Group Description	SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period		SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
All Cause Mortality
	SC Then SCCM		SCCM Then SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SC Then SCCM		SCCM Then SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	SC Then SCCM		SCCM Then SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.