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

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00765388
• Collaborator: (none)
• Enrollment: 27
• Locations: 6
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Background Urostomy is a surgical procedure that detours or diverts urine away form a diseased or defective bladder. The bladder can be removed and the urine is passed out of the body through an opening (stoma) in the stomach. People with urostomy will not be able to start and stop urine coming out through the stoma, so a urostomy bag will be fitted to collect the urine as it comes out.

A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a bag connected to the adhesive to collect the urine.

It is very important the standard is high on these products; otherwise the user (urostomy-patient) will experience lots of problems with the skin around the stoma.

Condition or Disease	Intervention/Treatment	Phase
Urostomy	Device: SenSura Uro; Device: Hollister	Phase 4

Detailed Description

In this trial we are comparing two types of urostomy bags - the SenSura 1-piece and Hollisters Moderma Flex.

Both products are CE-marked, meaning that they are safe and approved in use for people with an urostomy.

Population 30 urostomy operated people from UK will participate in the trial. Only participants who normally use a flat 1-piece urostomy bag can participate. It is very important that the participants keep their normal use- and change pattern. Furthermore they need to be over 18 years old, have had the urostomy for more than 3 months, the size of the urostomy shall be between 15-55 mm, otherwise the bag will not fit them and then they should be able to handle the bags themselves and be willing to use the two products tested in the trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SenSura Uro The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.	Device: SenSura Uro; The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.; Other Names: SenSura URO Standard Wear 1-piece bag Product number:1438298
Active Comparator: hollister Uro The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive	Device: Hollister; The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive.; Other Names: Moderma Flex Urostomy, Cut-to-fit bag, flat adhesive. product id : 29100

Outcome Measures

Primary Outcome Measures

1. Preference of Sensura vs Moderma [4 weeks]

   Subjects were asked which of the tested products they preferred; SenSura or Moderma.

Secondary Outcome Measures

1. Immediate Adhesion [4 weeks]

   Evaluation of immediate adhesion after each period

2. Removal of the Bag [4 weeks]

   How easy/difficult it was to remove the bag

3. Adhesion of the Bag During Use [4 weeks]

   Evaluation of the adhesion of the base plate around the stoma during use

4. Adhesives Ability to Absorb Perspiration [4 weeks]

   Evaluation of the adhesives ability to absorb perspiration from the skin

5. Flexibility of the Product [4 weeks]

   Evaluation of the ability of the bag to conform with the patients movements (flexibility)

6. Awareness of the Presence of the Product [4 weeks]

   Evaluates the patients awareness of the presence of the product during use.

7. Feeling of Security During the Day [4 weeks]

   The patients feeling of security with the bag during the day

8. Feeling of Security During the Night [4 weeks]

   The patients feeling of security with the product during the night

9. Problems With Splashing Sounds During Use [4 weeks]

   The patient was asked whether he/she noticed any splashinh sounds during use

10. Bag Twisting During Night [4 weeks]

    The patient was asked if he/she noticed whether the bag twisted during night

11. Changes in Skin Compared to Before Study [4 weeks]

    The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product

Eligibility Criteria

Criteria

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

Inclusion Criteria:

In order to be enrolled in the clinical investigation, the subject must:

• Be at least 18 years old,

• Be mentally and physically capable of signing the written consent form

• Be able to fill in the Case Report Form (questionnaire)

• Have an urostomy with a size between 15-55 mm.

• Have had the urostomy for 3 months or more,

• Use a 1-piece bag normally.

• Be able to handle the bag themselves (application and removal)

• Be willing to use Coloplast SenSura 1-piece bag

• Be willing to use Hollisters Moderma Flex, 1-piece bag

Exclusion Criteria:

In order to be enrolled in the clinical investigation, the subjects must not:

• Be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma forward)

• Need to use an ostomy belt

• Be currently suffering from any dermatologiacal problems, needing special treatment, in the peristomal area (investigator will evaluate skin according to a newly developed ostomy skin tool from Coloplast A/S)

• Being treated with chemo- or radiation therapy,

• Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or

• Be pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Peters Hospital	Chertsey	Surrey	United Kingdom	KT16OPZ
2	Caroline Rudoni	London	Tooting	United Kingdom	SW17OQT
3	Maureen Bridgland	Brighton		United Kingdom
4	Michael Lynch	Colchester		United Kingdom	CO45JL
5	University of London Hospital	London		United Kingdom	WC1E 5DB
6	Theresa Bowles	Norwich		United Kingdom

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Study Chair: Carol Katte, Stoma Nurse, Ashford and St. Peters Hospital
• Principal Investigator: Maureen Bridgland, Stoma Nurse, Royal Sussex County Hospital
• Principal Investigator: Caroline Rudoni, Stoma Nurse, St. Georges Hospital
• Principal Investigator: Theresa Bowles, Stoma Nurse, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
• Principal Investigator: Michael Lynch, Surgeon, Colchester General Hospital
• Principal Investigator: Sharon Fillingham, Nurse, UCLH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT00765388
• Other Study ID Numbers: DK188OS
• First Posted: Oct 2, 2008
• Last Update Posted: Mar 11, 2014
• Last Verified: Aug 1, 2012

• Keywords provided by Coloplast A/S: urostomy, 1-piece, cross-over, randomised, preference

Study Results

Participant Flow

Recruitment Details	Subjects where recruited by 6 stoma care sites in UK
Pre-assignment Detail	No pre-assignment details

Arm/Group Title	Hollister Uro First, Then SenSura Uro	SenSura Uro First, Then Hollister Uro
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	11
COMPLETED	15	6
NOT COMPLETED	1	5
Period Title: Period 1
STARTED	15	6
COMPLETED	15	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes groups randomized to receive SenSura Uro first and Hollister Uro first
Overall Participants	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (11.5)
Sex: Female, Male (Count of Participants)
Female	9 33.3%
Male	18 66.7%
Region of Enrollment (participants) [Number]
United Kingdom	27 100%

Outcome Measures

1. Primary Outcome

Title	Preference of Sensura vs Moderma
Description	Subjects were asked which of the tested products they preferred; SenSura or Moderma.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	27	27
Number [percentage of prefering the product]	45	43

2. Secondary Outcome

Title	Immediate Adhesion
Description	Evaluation of immediate adhesion after each period
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT)

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	21	20
Very poor	1 3.7%	1 NaN
Poor	1 3.7%	4 NaN
Reasonable	8 29.6%	4 NaN
Good	7 25.9%	6 NaN
Very good	4 14.8%	5 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SenSura Uro, Hollister Uro
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	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
Description	How easy/difficult it was to remove the bag
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very easy	5 18.5%	5 NaN
Easy	12 44.4%	11 NaN
Reasonable	5 18.5%	7 NaN
Difficult	0 0%	0 NaN
Very difficult	0 0%	0 NaN

4. Secondary Outcome

Title	Adhesion of the Bag During Use
Description	Evaluation of the adhesion of the base plate around the stoma during use
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very poor	2 7.4%	3 NaN
Poor	5 18.5%	5 NaN
Reasonable	7 25.9%	5 NaN
Good	3 11.1%	6 NaN
Very good	5 18.5%	4 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SenSura Uro, Hollister Uro
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	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
Description	Evaluation of the adhesives ability to absorb perspiration from the skin
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	21	22
Very poor	1 3.7%	0 NaN
Poor	2 7.4%	4 NaN
Reasonable	8 29.6%	7 NaN
Good	6 22.2%	9 NaN
Very good	4 14.8%	2 NaN

6. Secondary Outcome

Title	Flexibility of the Product
Description	Evaluation of the ability of the bag to conform with the patients movements (flexibility)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very poor	1 3.7%	1 NaN
Poor	0 0%	4 NaN
Reasonable	8 29.6%	5 NaN
Good	8 29.6%	10 NaN
Very good	5 18.5%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SenSura Uro, Hollister Uro
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	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
Description	Evaluates the patients awareness of the presence of the product during use.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very much	0 0%	2 NaN
Much	1 3.7%	3 NaN
Some	8 29.6%	5 NaN
A little	11 40.7%	10 NaN
Not at all	2 7.4%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SenSura Uro, Hollister Uro
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	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
Description	The patients feeling of security with the bag during the day
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very poor	3 11.1%	4 NaN
Poor	3 11.1%	4 NaN
Reasonable	5 18.5%	5 NaN
Good	7 25.9%	7 NaN
Very good	4 14.8%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SenSura Uro, Hollister Uro
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	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
Description	The patients feeling of security with the product during the night
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very poor	3 11.1%	3 NaN
Poor	4 14.8%	4 NaN
Reasonable	3 11.1%	6 NaN
Good	6 22.2%	7 NaN
Very good	6 22.2%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SenSura Uro, Hollister Uro
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	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
Description	The patient was asked whether he/she noticed any splashinh sounds during use
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Very much	0 0%	1 NaN
Much	0 0%	0 NaN
Some	3 11.1%	3 NaN
A little	4 14.8%	4 NaN
Not at all	15 55.6%	15 NaN

11. Secondary Outcome

Title	Bag Twisting During Night
Description	The patient was asked if he/she noticed whether the bag twisted during night
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	22	23
Yes	4 14.8%	13 NaN
No	18 66.7%	10 NaN

12. Secondary Outcome

Title	Changes in Skin Compared to Before Study
Description	The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	SenSura Uro	Hollister Uro
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.
Measure Participants	21	22
No, it is the same	17 63%	19 NaN
Yes, it is better	0 0%	1 NaN
Yes, it is worse	4 14.8%	2 NaN

Adverse Events

Time Frame	AE data where collected from inclusion and till the two test periods where completed (maximum 34 days)
Arm/Group Title	Hollister Uro		SenSura Uro
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hollister Uro		SenSura Uro
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Hollister Uro		SenSura Uro
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.