A Randomised Cross-over Study With Two 1-piece Urostomy Bags. (DK188OS)

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.

Study Overview

• Status: Completed
• Conditions: Urostomy
• Intervention / Treatment: Device: SenSura Uro; Device: Hollister

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom
    • Maureen Bridgland
  • Colchester, United Kingdom, CO45JL
    • Michael Lynch
  • London, United Kingdom, WC1E 5DB
    • University of London Hospital
  • Norwich, United Kingdom
    • Theresa Bowles
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16OPZ
      • St. Peters Hospital
  • Tooting
    • London, Tooting, United Kingdom, SW17OQT
      • Caroline Rudoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SenSura Uro; The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.	Device: SenSura Uro; The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.; Other Names: SenSura URO Standard Wear 1-piece bag; Product number:1438298
ACTIVE_COMPARATOR: hollister Uro; 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	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.; Other Names: Moderma Flex Urostomy, Cut-to-fit bag, flat adhesive.; product id : 29100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference of Sensura vs Moderma	Subjects were asked which of the tested products they preferred; SenSura or Moderma.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate Adhesion	Evaluation of immediate adhesion after each period	4 weeks
Removal of the Bag	How easy/difficult it was to remove the bag	4 weeks
Adhesion of the Bag During Use	Evaluation of the adhesion of the base plate around the stoma during use	4 weeks
Adhesives Ability to Absorb Perspiration	Evaluation of the adhesives ability to absorb perspiration from the skin	4 weeks
Flexibility of the Product	Evaluation of the ability of the bag to conform with the patients movements (flexibility)	4 weeks
Awareness of the Presence of the Product	Evaluates the patients awareness of the presence of the product during use.	4 weeks
Feeling of Security During the Day	The patients feeling of security with the bag during the day	4 weeks
Feeling of Security During the Night	The patients feeling of security with the product during the night	4 weeks
Problems With Splashing Sounds During Use	The patient was asked whether he/she noticed any splashinh sounds during use	4 weeks
Bag Twisting During Night	The patient was asked if he/she noticed whether the bag twisted during night	4 weeks
Changes in Skin Compared to Before Study	The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product	4 weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Chair: Carol Katte, Stoma Nurse, Ashford and St. Peters Hospital; Principal Investigator: Maureen Bridgland, Stoma Nurse, Royal Sussex County Hospital; Principal Investigator: Caroline Rudoni, Stoma Nurse, St. Georges Hospital; Principal Investigator: Theresa Bowles, Stoma Nurse, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK); Principal Investigator: Michael Lynch, Surgeon, Colchester General Hospital; Principal Investigator: Sharon Fillingham, Nurse, UCLH

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (ESTIMATE): October 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: urostomy, 1-piece, cross-over, randomised, preference
• Other Study ID Numbers: DK188OS