Trial Outcomes & Findings for A Randomised Cross-over Study With Two 1-piece Urostomy Bags. (NCT NCT00765388)

NCT ID: NCT00765388

Last Updated: 2014-03-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 27 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2014-03-11

Participant Flow

Subjects where recruited by 6 stoma care sites in UK

No pre-assignment details

Participant milestones

Measure	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.
Period 1 STARTED	16	11
Period 1 COMPLETED	15	6
Period 1 NOT COMPLETED	1	5
Period 2 STARTED	15	6
Period 2 COMPLETED	15	6
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.
Period 1 Lack of Efficacy	1	2
Period 1 Lost to Follow-up	0	1
Period 1 Herpes Zoster	0	1
Period 1 Hip operation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Entire Study Population n=27 Participants Includes groups randomized to receive SenSura Uro first and Hollister Uro first
Age, Continuous	61.6 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United Kingdom	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	SenSura Uro n=27 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=27 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Preference of Sensura vs Moderma	45 percentage of prefering the product	43 percentage of prefering the product

SECONDARY outcome

Timeframe: 4 weeks

Population: Intention to treat (ITT)

Evaluation of immediate adhesion after each period

Outcome measures

Measure	SenSura Uro n=21 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=20 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Immediate Adhesion Very poor	1 Participants	1 Participants
Immediate Adhesion Poor	1 Participants	4 Participants
Immediate Adhesion Reasonable	8 Participants	4 Participants
Immediate Adhesion Good	7 Participants	6 Participants
Immediate Adhesion Very good	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

How easy/difficult it was to remove the bag

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Removal of the Bag Very easy	5 Participants	5 Participants
Removal of the Bag Easy	12 Participants	11 Participants
Removal of the Bag Reasonable	5 Participants	7 Participants
Removal of the Bag Difficult	0 Participants	0 Participants
Removal of the Bag Very difficult	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

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

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Adhesion of the Bag During Use Very poor	2 Participants	3 Participants
Adhesion of the Bag During Use Poor	5 Participants	5 Participants
Adhesion of the Bag During Use Reasonable	7 Participants	5 Participants
Adhesion of the Bag During Use Good	3 Participants	6 Participants
Adhesion of the Bag During Use Very good	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

Evaluation of the adhesives ability to absorb perspiration from the skin

Outcome measures

Measure	SenSura Uro n=21 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Adhesives Ability to Absorb Perspiration Very poor	1 Participants	0 Participants
Adhesives Ability to Absorb Perspiration Poor	2 Participants	4 Participants
Adhesives Ability to Absorb Perspiration Reasonable	8 Participants	7 Participants
Adhesives Ability to Absorb Perspiration Good	6 Participants	9 Participants
Adhesives Ability to Absorb Perspiration Very good	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

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

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Flexibility of the Product Very poor	1 Participants	1 Participants
Flexibility of the Product Poor	0 Participants	4 Participants
Flexibility of the Product Reasonable	8 Participants	5 Participants
Flexibility of the Product Good	8 Participants	10 Participants
Flexibility of the Product Very good	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

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

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Awareness of the Presence of the Product Very much	0 Participants	2 Participants
Awareness of the Presence of the Product Much	1 Participants	3 Participants
Awareness of the Presence of the Product Some	8 Participants	5 Participants
Awareness of the Presence of the Product A little	11 Participants	10 Participants
Awareness of the Presence of the Product Not at all	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

The patients feeling of security with the bag during the day

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Feeling of Security During the Day Very poor	3 Participants	4 Participants
Feeling of Security During the Day Poor	3 Participants	4 Participants
Feeling of Security During the Day Reasonable	5 Participants	5 Participants
Feeling of Security During the Day Good	7 Participants	7 Participants
Feeling of Security During the Day Very good	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

The patients feeling of security with the product during the night

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Feeling of Security During the Night Very poor	3 Participants	3 Participants
Feeling of Security During the Night Poor	4 Participants	4 Participants
Feeling of Security During the Night Reasonable	3 Participants	6 Participants
Feeling of Security During the Night Good	6 Participants	7 Participants
Feeling of Security During the Night Very good	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

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

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Problems With Splashing Sounds During Use Very much	0 Participants	1 Participants
Problems With Splashing Sounds During Use Much	0 Participants	0 Participants
Problems With Splashing Sounds During Use Some	3 Participants	3 Participants
Problems With Splashing Sounds During Use A little	4 Participants	4 Participants
Problems With Splashing Sounds During Use Not at all	15 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

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

Outcome measures

Measure	SenSura Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=23 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Bag Twisting During Night Yes	4 Participants	13 Participants
Bag Twisting During Night No	18 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

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

Outcome measures

Measure	SenSura Uro n=21 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.	Hollister Uro n=22 Participants SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
Changes in Skin Compared to Before Study No, it is the same	17 Participants	19 Participants
Changes in Skin Compared to Before Study Yes, it is better	0 Participants	1 Participants
Changes in Skin Compared to Before Study Yes, it is worse	4 Participants	2 Participants

Adverse Events

Hollister Uro

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SenSura Uro

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Seema Suchdev Wrisberg

Coloplast A/S

Phone: +4549113519

Email: dkssw@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER