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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SenSura Uro | Experimental | The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive. |
|
| hollister Uro | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura Uro | Device | The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preference of Sensura vs Moderma | Subjects were asked which of the tested products they preferred; SenSura or Moderma. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Adhesion | Evaluation of immediate adhesion after each period | 4 weeks |
| Removal of the Bag | How easy/difficult it was to remove the bag |
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Inclusion Criteria:
In order to be enrolled in the clinical investigation, the subject must:
Exclusion Criteria:
In order to be enrolled in the clinical investigation, the subjects must not:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Katte, Stoma Nurse | Ashford and St. Peters Hospital | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Peters Hospital | Chertsey | Surrey | KT16OPZ | United Kingdom | ||
| Caroline Rudoni |
No pre-assignment details
Subjects where recruited by 6 stoma care sites in UK
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| ID | Title | Description |
|---|---|---|
| FG000 | Hollister Uro First, Then SenSura Uro | SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices. |
| FG001 | SenSura Uro First, Then Hollister Uro | SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive SenSura Uro first and Hollister Uro first |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Preference of Sensura vs Moderma | Subjects were asked which of the tested products they preferred; SenSura or Moderma. | Posted | Number | percentage of prefering the product | 4 weeks |
|
AE data where collected from inclusion and till the two test periods where completed (maximum 34 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hollister Uro | SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seema Suchdev Wrisberg | Coloplast A/S | +4549113519 | dkssw@coloplast.com |
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| Hollister | Device | 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. |
|
|
| 4 weeks |
| Adhesion of the Bag During Use | Evaluation of the adhesion of the base plate around the stoma during use | 4 weeks |
| Adhesives Ability to Absorb Perspiration | Evaluation of the adhesives ability to absorb perspiration from the skin | 4 weeks |
| Flexibility of the Product | Evaluation of the ability of the bag to conform with the patients movements (flexibility) | 4 weeks |
| Awareness of the Presence of the Product | Evaluates the patients awareness of the presence of the product during use. | 4 weeks |
| Feeling of Security During the Day | The patients feeling of security with the bag during the day | 4 weeks |
| Feeling of Security During the Night | The patients feeling of security with the product during the night | 4 weeks |
| Problems With Splashing Sounds During Use | The patient was asked whether he/she noticed any splashinh sounds during use | 4 weeks |
| Bag Twisting During Night | The patient was asked if he/she noticed whether the bag twisted during night | 4 weeks |
| Changes in Skin Compared to Before Study | The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product | 4 weeks |
| London |
| Tooting |
| SW17OQT |
| United Kingdom |
| Maureen Bridgland | Brighton | United Kingdom |
| Michael Lynch | Colchester | CO45JL | United Kingdom |
| University of London Hospital | London | WC1E 5DB | United Kingdom |
| Theresa Bowles | Norwich | United Kingdom |
| Herpes Zoster |
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| Hip operation |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Immediate Adhesion | Evaluation of immediate adhesion after each period | Intention to treat (ITT) | Posted | Number | Participants | 4 weeks |
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| Secondary | Removal of the Bag | How easy/difficult it was to remove the bag | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Adhesion of the Bag During Use | Evaluation of the adhesion of the base plate around the stoma during use | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Adhesives Ability to Absorb Perspiration | Evaluation of the adhesives ability to absorb perspiration from the skin | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Flexibility of the Product | Evaluation of the ability of the bag to conform with the patients movements (flexibility) | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Awareness of the Presence of the Product | Evaluates the patients awareness of the presence of the product during use. | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Feeling of Security During the Day | The patients feeling of security with the bag during the day | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Feeling of Security During the Night | The patients feeling of security with the product during the night | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Problems With Splashing Sounds During Use | The patient was asked whether he/she noticed any splashinh sounds during use | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Bag Twisting During Night | The patient was asked if he/she noticed whether the bag twisted during night | ITT population | Posted | Number | Participants | 4 weeks |
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| Secondary | Changes in Skin Compared to Before Study | The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product | ITT population | Posted | Number | Participants | 4 weeks |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | SenSura Uro | SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices. | 0 | 11 | 0 | 11 |
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.
| Reasonable |
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| Good |
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| Very good |
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| Reasonable |
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| Difficult |
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| Very difficult |
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| Reasonable |
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| Good |
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| Very good |
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| Reasonable |
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| Good |
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| Very good |
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| Reasonable |
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| Good |
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| Very good |
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| Some |
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| A little |
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| Not at all |
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| Reasonable |
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| Good |
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| Very good |
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| Reasonable |
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| Good |
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| Very good |
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| Some |
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| A little |
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| Not at all |
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| Yes, it is worse |
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