Phase 3
N=30
Comparison of Two Urostomy Bags (2-piece).
Urostomy Patent
Bottom Line
View on ClinicalTrials.gov: NCT00761748 ↗Enrolled (actual)
30
Serious AEs
1.7%
Results posted
Jan 2013
Primary outcome: Primary: Preference of the Two Urostomy Products — 21; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Convatec Uro 2-piece (Device); SenSura Uro 2-piece (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preference of the Two Urostomy Products |
21; 4 | — |
Summary
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00761748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.