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

NCT00765388 | Completed Phase 4 Results

• 1 other identifier: DK188OS
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

urostomy, 1-piece, cross-over, randomised, preference

Outcome Measures

Primary Outcomes (1)

• Preference of Sensura vs Moderma

  Subjects were asked which of the tested products they preferred; SenSura or Moderma.

  4 weeks

Secondary Outcomes (11)

• Immediate Adhesion

  4 weeks

• Removal of the Bag

  4 weeks

• Adhesion of the Bag During Use

  4 weeks

• Adhesives Ability to Absorb Perspiration

  4 weeks

• Flexibility of the Product

  4 weeks

Study Arms (2)

SenSura Uro

EXPERIMENTAL

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

Device: SenSura Uro

hollister Uro

ACTIVE COMPARATOR

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

Interventions

SenSura Uro DEVICE

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

Also known as: SenSura URO Standard Wear 1-piece bag, Product number:1438298

SenSura Uro

Hollister DEVICE

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.

Also known as: Moderma Flex Urostomy, Cut-to-fit bag, flat adhesive., product id : 29100

hollister Uro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (6)

St. Peters Hospital

Chertsey, Surrey, KT16OPZ, United Kingdom

Location

Caroline Rudoni

London, Tooting, SW17OQT, United Kingdom

Location

Maureen Bridgland

Brighton, United Kingdom

Location

Michael Lynch

Colchester, CO45JL, United Kingdom

Location

University of London Hospital

London, WC1E 5DB, United Kingdom

Location

Theresa Bowles

Norwich, United Kingdom

Location

Results Point of Contact

• Title: Seema Suchdev Wrisberg
• Organization: Coloplast A/S

dkssw@coloplast.com

+4549113519

Study Officials

• Carol Katte, Stoma Nurse

  Ashford and St. Peters Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 11, 2014
• Results First Posted: March 11, 2014

Record last verified: 2012-08

Locations

GB (6)