Urostomy Patent
Conditions
Keywords
Urostomy,, 2-piece,, preference,
Brief summary
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Detailed description
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
Interventions
DEVICEConvatec Uro 2-piece
Specific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'. The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look.
DEVICESenSura Uro 2-piece
SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years old, * Be able to complete a written consent form * Be able to fill in the Case Report Form * Have a urostomy with a diameter of 33 mm. or less. * Have had the urostomy for 3 months or more. * Use a 2-piece convex (or convex light) normally. * Be able to use SenSura URO 2-piece product * Be able to use ConvaTec, 2-piece product * Be able to handle the product themselves (application, removal and emptying),
Exclusion criteria
* In order to be enrolled in the clinical investigation, the subjects must not: * Need to use an ostomy belt * Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference of the Two Urostomy Products | 6 weeks | Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred. |
Countries
Germany
Participant flow
Recruitment details
The subjects were recruited by the investigators at multiple sites in Germany.
Pre-assignment details
39 subjects were enrolled in the study, however 9 subjects were excluded from participating in the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population Urostomy operated subjects | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (21 +/- 3 Days) | Adverse Event | 3 | 0 |
| First Intervention (21 +/- 3 Days) | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age Continuous | 68 years |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 30 | 0 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 |
Outcome results
Primary
Preference of the Two Urostomy Products
Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
Time frame: 6 weeks
Population: The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). \*One drop out was evaluable, as the subject tried both products and stated a preference.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensura Uro 2 Piece | Preference of the Two Urostomy Products | 21 participants |
| Convatec 2 Piece | Preference of the Two Urostomy Products | 4 participants |