Phase 4
Completed N=27
A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Urostomy
Source: ClinicalTrials.gov NCT00765388 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Preference of Sensura vs Moderma — 45; 43 percentage of prefering the product
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preference of Sensura vs Moderma |
45; 43 | — |
| SECONDARY Immediate Adhesion |
1; 1; 1; 4; 8; 4 | 0.96 |
| SECONDARY Removal of the Bag |
5; 5; 12; 11; 5; 7 | — |
| SECONDARY Adhesion of the Bag During Use |
2; 3; 5; 5; 7; 5 | 0.92 |
| SECONDARY Adhesives Ability to Absorb Perspiration |
1; 0; 2; 4; 8; 7 | — |
| SECONDARY Flexibility of the Product |
1; 1; 0; 4; 8; 5 | 0.40 |
| SECONDARY Awareness of the Presence of the Product |
0; 2; 1; 3; 8; 5 | 0.64 |
| SECONDARY Feeling of Security During the Day |
3; 4; 3; 4; 5; 5 | 0.55 |
| SECONDARY Feeling of Security During the Night |
3; 3; 4; 4; 3; 6 | 0.48 |
| SECONDARY Problems With Splashing Sounds During Use |
0; 1; 0; 0; 3; 3 | — |
| SECONDARY Bag Twisting During Night |
4; 13; 18; 10 | — |
| SECONDARY Changes in Skin Compared to Before Study |
17; 19; 0; 1; 4; 2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00765388). 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. Informational only — not medical advice.