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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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