CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
SenSura Uro +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00765388
NCT00765388Phase 4Completed
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A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK

Coloplast A/S·interventional·Posted Oct 2, 2008·Updated Mar 11, 2014

In Brief

A Phase 4 clinical trial evaluating SenSura Uro and Hollister for Urostomy. Completed, enrolled 27 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrostomy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2008
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago

Interventions

SenSura Urodevice

The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.

Hollisterdevice

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.