Urostomy Clinical Trial
Official title:
A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04334226 -
The Impact of Preoperative Urostomy Education on Patients and Families
|
||
| Recruiting |
NCT02499588 -
User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
|
N/A |