Product Evaluation of a Newly Developed Intermittent Catheter.

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02966015
• Collaborator: (none)
• Enrollment: 153
• Arm: 1
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the navigation of a newly developed catheter.

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urinary	Device: Coloplast test catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Testing the new Coloplast Test catheter The subjects used the new Coloplast Test catheter for 1 week	Device: Coloplast test catheter; This is a newly developed catheter

Outcome Measures

Primary Outcome Measures

1. Number of Participants Successfully Able to Insert Catheter [1 week]

   The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Male and at least 18 years

2. Has used Intermittent self-catheterization at least 3 months

3. Has normal to slightly reduced hand mobility

4. Use catheter size CH12 or CH14 (must use same size during product evaluation)

Exclusion Criteria:

1. Currently receiving treatment for urinary tract infection

2. Currently receiving chemotherapy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Study Chair: Camilla F Vibjerg, Msc, Head of clinical operation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT02966015
• Other Study ID Numbers: CP268
• First Posted: Nov 17, 2016
• Last Update Posted: Feb 28, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

Participant Flow

Arm/Group Title	Tiemann/Coudé Users	Traditional Sleeve Catheter Users
Arm/Group Description	The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
Period Title: Inclusion Visit
STARTED	95	58
COMPLETED	87	55
NOT COMPLETED	8	3
Period Title: Inclusion Visit
STARTED	87	55
COMPLETED	87	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Tiemann/Coudé Users	Traditional Sleeve Catheter Users	Total
Arm/Group Description	The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.	Total of all reporting groups
Overall Participants	95	58	153
Age, Customized (participants) [Number]
Participants older than 18 years	95 100%	58 100%	153 100%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	95 100%	58 100%	153 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Successfully Able to Insert Catheter
Description	The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tiemann/Coudé Users	Traditional Sleeve Catheter Users
Arm/Group Description	The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
Measure Participants	95	58
Count of Participants [Participants]	82 86.3%	58 100%

Adverse Events

Time Frame	Adverse events were collected during the trial period
Arm/Group Title	Tiemann/Coudé Users		Traditional Sleeve Catheter Users
Arm/Group Description	The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter		The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
All Cause Mortality
	Tiemann/Coudé Users		Traditional Sleeve Catheter Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/58 (0%)
Serious Adverse Events
	Tiemann/Coudé Users		Traditional Sleeve Catheter Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/58 (0%)
Other (Not Including Serious) Adverse Events
	Tiemann/Coudé Users		Traditional Sleeve Catheter Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/58 (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.