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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK

Conditions
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Urostomy

Intervention / Treatment
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* Device: SenSura Uro
* Device: Hollister


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SenSura Uro<br>The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive. | Device: SenSura Uro<br>* The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.<br>* Other names: Product number:1438298;|
| Active Comparator: hollister Uro<br>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<br>* 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.<br>* Other names: product id : 29100;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urostomy, 1-piece, cross-over, randomised, preference