A Randomised Cross-over Study With Two 1-piece Urostomy Bags. (DK188OS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00765388
First received: October 1, 2008
Last updated: January 27, 2014
Last verified: August 2012
Results First Received: September 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Urostomy
Interventions: Device: SenSura Uro
Device: Hollister

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects where recruited by 6 stoma care sites in UK

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No pre-assignment details

Reporting Groups
  Description
Hollister Uro First, Then SenSura Uro SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro First, Then Hollister Uro SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.

Participant Flow for 2 periods

Period 1:   Period 1
    Hollister Uro First, Then SenSura Uro     SenSura Uro First, Then Hollister Uro  
STARTED     16 [1]   11  
COMPLETED     15     6  
NOT COMPLETED     1     5  
Lack of Efficacy                 1                 2  
Lost to Follow-up                 0                 1  
Herpes Zoster                 0                 1  
Hip operation                 0                 1  
[1] A cross-over study

Period 2:   Period 2
    Hollister Uro First, Then SenSura Uro     SenSura Uro First, Then Hollister Uro  
STARTED     15     6  
COMPLETED     15     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Entire Study Population Includes groups randomized to receive SenSura Uro first and Hollister Uro first

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 11.5  
Gender  
[units: participants]
 
Female     9  
Male     18  
Region of Enrollment  
[units: participants]
 
United Kingdom     27  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Preference of Sensura vs Moderma   [ Time Frame: 4 weeks ]

2.  Secondary:   Immediate Adhesion   [ Time Frame: 4 weeks ]

3.  Secondary:   Removal of the Bag   [ Time Frame: 4 weeks ]

4.  Secondary:   Adhesion of the Bag During Use   [ Time Frame: 4 weeks ]

5.  Secondary:   Adhesives Ability to Absorb Perspiration   [ Time Frame: 4 weeks ]

6.  Secondary:   Flexibility of the Product   [ Time Frame: 4 weeks ]

7.  Secondary:   Awareness of the Presence of the Product   [ Time Frame: 4 weeks ]

8.  Secondary:   Feeling of Security During the Day   [ Time Frame: 4 weeks ]

9.  Secondary:   Feeling of Security During the Night   [ Time Frame: 4 weeks ]

10.  Secondary:   Problems With Splashing Sounds During Use   [ Time Frame: 4 weeks ]

11.  Secondary:   Bag Twisting During Night   [ Time Frame: 4 weeks ]

12.  Secondary:   Changes in Skin Compared to Before Study   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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: Seema Suchdev Wrisberg
Organization: Coloplast A/S
phone: +4549113519
e-mail: dkssw@coloplast.com


No publications provided


Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00765388     History of Changes
Other Study ID Numbers: DK188OS
Study First Received: October 1, 2008
Results First Received: September 19, 2011
Last Updated: January 27, 2014
Health Authority: United Kingdom: Research Ethics Committee