Comparison of Two Urostomy Bags (2-piece).

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Coloplast A/S

ClinicalTrials.gov Identifier:

NCT00761748

First received: September 26, 2008

Last updated: November 29, 2012

Last verified: November 2012

History of Changes

Results First Received: March 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Urostomy Patent
Interventions:	Device: Convatec Uro 2-piece Device: SenSura Uro 2-piece

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The subjects were recruited by the investigators at multiple sites in Germany.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
39 subjects were enrolled in the study, however 9 subjects were excluded from participating in the study.

Reporting Groups

	Description
Sensura Uro 2 Piece First, Then Convatec 2 Piece	Sensura is a newly developed two piece product for people with urostomies.
ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece	Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.

Participant Flow for 2 periods

Period 1: First Intervention (21 +/- 3 Days)

	Sensura Uro 2 Piece First, Then Convatec 2 Piece	ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece
STARTED	20	10
COMPLETED	17	7
NOT COMPLETED	3	3
Adverse Event	3	0
Lost to Follow-up	0	3

Period 2: Second Intervention (21 +/- 3 Days)

	Sensura Uro 2 Piece First, Then Convatec 2 Piece	ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece
STARTED	17	7
COMPLETED	17	7
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall Study Population	Urostomy operated subjects

Baseline Measures

	Overall Study Population
Number of Participants [units: participants]	30
Age [units: years] Median ( Full Range )	68 ( 42 to 82 )
Gender [units: participants]
Female	15
Male	15

Outcome Measures

1. Primary:

Preference of the Two Urostomy Products [ Time Frame: 6 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Director of Medical Outcome
Organization: Coloplast A/S
e-mail: dkbir@coloplast.com

No publications provided

Responsible Party:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00761748 History of Changes
Other Study ID Numbers:	DK189OS
Study First Received:	September 26, 2008
Results First Received:	March 8, 2010
Last Updated:	November 29, 2012
Health Authority:	Germany: Ethics Commission

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