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A Randomised Cross-over Study With Two 1-piece Urostomy Bags.

NCT00765388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-03-11

Study results available
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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.

Conditions

  • Urostomy

Interventions

DEVICE

SenSura Uro

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

DEVICE

Hollister

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.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Carol Katte, Stoma Nurse · Ashford and St. Peters Hospital

  • Maureen Bridgland, Stoma Nurse · Royal Sussex County Hospital

  • Caroline Rudoni, Stoma Nurse · St. Georges Hospital

  • Theresa Bowles, Stoma Nurse · Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  • Michael Lynch, Surgeon · Colchester General Hospital

  • Sharon Fillingham, Nurse · UCLH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00765388 on ClinicalTrials.gov