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

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ClinicalTrials.gov Identifier: NCT00765388
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Urostomy
Interventions Device: SenSura Uro
Device: Hollister
Enrollment 27
Recruitment Details Subjects where recruited by 6 stoma care sites in UK
Pre-assignment Details No pre-assignment details
Arm/Group Title Hollister Uro First, Then SenSura Uro SenSura Uro First, Then Hollister Uro
Hide Arm/Group Description SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices. SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Period Title: Period 1
Started 16 [1] 11
Completed 15 6
Not Completed 1 5
Reason Not Completed
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 Title: Period 2
Started 15 6
Completed 15 6
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive SenSura Uro first and Hollister Uro first
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
61.6  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
9
  33.3%
Male
18
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 27 participants
27
1.Primary Outcome
Title Preference of Sensura vs Moderma
Hide Description Subjects were asked which of the tested products they preferred; SenSura or Moderma.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of prefering the product
45 43
2.Secondary Outcome
Title Immediate Adhesion
Hide Description Evaluation of immediate adhesion after each period
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 21 20
Measure Type: Number
Unit of Measure: Participants
Very poor 1 1
Poor 1 4
Reasonable 8 4
Good 7 6
Very good 4 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SenSura Uro, Hollister Uro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Regression, Logistic
Comments An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products
3.Secondary Outcome
Title Removal of the Bag
Hide Description How easy/difficult it was to remove the bag
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very easy 5 5
Easy 12 11
Reasonable 5 7
Difficult 0 0
Very difficult 0 0
4.Secondary Outcome
Title Adhesion of the Bag During Use
Hide Description Evaluation of the adhesion of the base plate around the stoma during use
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very poor 2 3
Poor 5 5
Reasonable 7 5
Good 3 6
Very good 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SenSura Uro, Hollister Uro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Regression, Logistic
Comments An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products
5.Secondary Outcome
Title Adhesives Ability to Absorb Perspiration
Hide Description Evaluation of the adhesives ability to absorb perspiration from the skin
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 21 22
Measure Type: Number
Unit of Measure: Participants
Very poor 1 0
Poor 2 4
Reasonable 8 7
Good 6 9
Very good 4 2
6.Secondary Outcome
Title Flexibility of the Product
Hide Description Evaluation of the ability of the bag to conform with the patients movements (flexibility)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very poor 1 1
Poor 0 4
Reasonable 8 5
Good 8 10
Very good 5 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SenSura Uro, Hollister Uro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Regression, Logistic
Comments An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products
7.Secondary Outcome
Title Awareness of the Presence of the Product
Hide Description Evaluates the patients awareness of the presence of the product during use.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very much 0 2
Much 1 3
Some 8 5
A little 11 10
Not at all 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SenSura Uro, Hollister Uro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Regression, Logistic
Comments An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products
8.Secondary Outcome
Title Feeling of Security During the Day
Hide Description The patients feeling of security with the bag during the day
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very poor 3 4
Poor 3 4
Reasonable 5 5
Good 7 7
Very good 4 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SenSura Uro, Hollister Uro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Regression, Logistic
Comments An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products
9.Secondary Outcome
Title Feeling of Security During the Night
Hide Description The patients feeling of security with the product during the night
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very poor 3 3
Poor 4 4
Reasonable 3 6
Good 6 7
Very good 6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SenSura Uro, Hollister Uro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Regression, Logistic
Comments An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products
10.Secondary Outcome
Title Problems With Splashing Sounds During Use
Hide Description The patient was asked whether he/she noticed any splashinh sounds during use
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Very much 0 1
Much 0 0
Some 3 3
A little 4 4
Not at all 15 15
11.Secondary Outcome
Title Bag Twisting During Night
Hide Description The patient was asked if he/she noticed whether the bag twisted during night
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
Yes 4 13
No 18 10
12.Secondary Outcome
Title Changes in Skin Compared to Before Study
Hide Description The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SenSura Uro Hollister Uro
Hide Arm/Group Description:
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Overall Number of Participants Analyzed 21 22
Measure Type: Number
Unit of Measure: Participants
No, it is the same 17 19
Yes, it is better 0 1
Yes, it is worse 4 2
Time Frame AE data where collected from inclusion and till the two test periods where completed (maximum 34 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hollister Uro SenSura Uro
Hide Arm/Group Description SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices. SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
All-Cause Mortality
Hollister Uro SenSura Uro
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hollister Uro SenSura Uro
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hollister Uro SenSura Uro
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/11 (0.00%) 
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.
Investigator may publish the Inventions subject to the prior written consent of Sponsor. The Investigator shall submit the manuscript to Sponsor for approval, provided however that the Investigator will submit the manuscript at least thirty (30) days before disclosure for such proposed publication. If Sponsor wishes to file patent applications on Inventions Sponsor is allowed to delay the publication upon to a maximum period of 6 months since he above-mentioned submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Seema Suchdev Wrisberg
Organization: Coloplast A/S
Phone: +4549113519
EMail: dkssw@coloplast.com
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00765388     History of Changes
Other Study ID Numbers: DK188OS
First Submitted: October 1, 2008
First Posted: October 2, 2008
Results First Submitted: September 19, 2011
Results First Posted: March 11, 2014
Last Update Posted: March 11, 2014