Bladder Scan of Residual Urine With New Catheter

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01048541
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Device: Test Catheter - SpeediCath Compact Male; Device: SpeediCath	Phase 2/Phase 3

Detailed Description

See brief summary

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SpeediCath catheter Standard treatment	Device: SpeediCath; Catheter for intermittent catheterisation; Other Names: Test catheter
Experimental: Test product	Device: Test Catheter - SpeediCath Compact Male; Compact catheter for intermittent catheterisation; Other Names: SpeediCath Test catheter

Outcome Measures

Primary Outcome Measures

1. Mean Residual Urine Volume [3 catheterisations on 1 day]

   Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation

Secondary Outcome Measures

1. The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) [Study period]

2. Median Absolute RU Volume [3 catheterisations on 1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is a male IC user able to self-catheterise

2. Subject has used hydrophilic-coated ICs for at least 1 month

3. Subject is at least 18 years old.

4. Subject has provided informed consent.

Exclusion Criteria:

1. Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).

2. Subject has known abnormalities in the lower urinary tract.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Werner-Wicker-Klinik, Abteilung für Neuro-Urologie	Bad Wildungen	Hessen	Germany	34537

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Burkhard Domurath, Dr. med., Werner Wicker Klinik
• Study Director: Henrik S Knoth, M.Sc Pharm, Coloplast A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01048541
• Other Study ID Numbers: CP061CC
• First Posted: Jan 13, 2010
• Last Update Posted: Sep 3, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Urinary Incontinence

Study Results

Participant Flow

Arm/Group Title	AB: First Test Catheter Then Standard Catheter	BA: First Standard Catheter Then Test Catheter
Arm/Group Description	Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period	Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
Period Title: Overall Study
STARTED	18	19
COMPLETED	17	19
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Entire Study
Arm/Group Description	Includes groups randomized to standard catheter first and test catheter first
Overall Participants	37
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	36 97.3%
>=65 years	1 2.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.5 (12.7)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	37 100%
Region of Enrollment (participants) [Number]
Germany	37 100%

Outcome Measures

1. Primary Outcome

Title	Mean Residual Urine Volume
Description	Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation
Time Frame	3 catheterisations on 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Catheter	Standard Catheter
Arm/Group Description	Test catheter (SpeediCath Compact Male)	Standard catheter (SpediCath straight)
Measure Participants	36	36
Mean (Standard Deviation) [mL]	12.4 (15.7)	9.4 (11.4)

2. Secondary Outcome

Title	The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)
Time Frame	Study period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Median Absolute RU Volume
Time Frame	3 catheterisations on 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Test Catheter		Standard Catheter
Arm/Group Description	Test catheter (SpeediCath Compact Male)		Standard catheter (SpediCath straight)
All Cause Mortality
	Test Catheter		Standard Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Test Catheter		Standard Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Test Catheter		Standard Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)		0/36 (0%)
Renal and urinary disorders
Burning in the urethra	1/36 (2.8%)		0/36 (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.