UrostomyPhase 4DK188OSNCT00765388
A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
A Phase 4 study testing SenSura Uro and Hollister in people with Urostomy, run by Coloplast A/S at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urostomy
- What is being tested?
- SenSura Uro and Hollister
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Oct 2008to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Maureen Bridgland
Brighton
St. Peters Hospital
Chertsey, Surrey, KT16OPZ
Michael Lynch
Colchester, CO45JL
Caroline Rudoni
London, Tooting, SW17OQT
University of London Hospital
London, WC1E 5DB
Theresa Bowles
Norwich
About this study
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.
Read the 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.
- Conditions
- Urostomy
- Being tested
- SenSura Uro, Hollister
- Keywords
- urostomy, 1-piece, cross-over, randomised, preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSura UroDevice
Also called SenSura URO Standard Wear 1-piece bag, Product number:1438298
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
HollisterDevice
Also called Moderma Flex Urostomy, Cut-to-fit bag, flat adhesive., product id : 29100
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.
| Study group | Role | What they receive |
|---|---|---|
| SenSura Uro | Experimental | The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive. Receives: 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 Receives: Device: Hollister |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of Sensura vs Moderma
Subjects were asked which of the tested products they preferred; SenSura or Moderma.
Measured: 4 weeks
Secondary outcomes (11)
Immediate Adhesion
Evaluation of immediate adhesion after each period
Measured: 4 weeks
Removal of the Bag
How easy/difficult it was to remove the bag
Measured: 4 weeks
Adhesion of the Bag During Use
Evaluation of the adhesion of the base plate around the stoma during use
Measured: 4 weeks
Adhesives Ability to Absorb Perspiration
Evaluation of the adhesives ability to absorb perspiration from the skin
Measured: 4 weeks
Flexibility of the Product
Evaluation of the ability of the bag to conform with the patients movements (flexibility)
Measured: 4 weeks
Awareness of the Presence of the Product
Evaluates the patients awareness of the presence of the product during use.
Measured: 4 weeks
Feeling of Security During the Day
The patients feeling of security with the bag during the day
Measured: 4 weeks
Feeling of Security During the Night
The patients feeling of security with the product during the night
Measured: 4 weeks
Problems With Splashing Sounds During Use
The patient was asked whether he/she noticed any splashinh sounds during use
Measured: 4 weeks
Bag Twisting During Night
The patient was asked if he/she noticed whether the bag twisted during night
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Katte, Stoma Nurse, Study chair, Ashford and St. Peters HospitalMaureen Bridgland, Stoma Nurse, Principal investigator, Royal Sussex County HospitalCaroline Rudoni, Stoma Nurse, Principal investigator, St. Georges HospitalTheresa Bowles, Stoma Nurse, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)Michael Lynch, Surgeon, Principal investigator, Colchester General HospitalSharon Fillingham, Nurse, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765388
- Sponsor's protocol ID
- DK188OS
- Acronym
- DK188OS
- Status last verified
- Aug 2012
- First submitted
- 1 Oct 2008
- Last updated
- 11 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK
- ClinicalTrials.gov ID
- NCT00765388
- Acronym / sponsor ID
- DK188OS / DK188OS
- Conditions
- Urostomy
- Keywords
- urostomy, 1-piece, cross-over, randomised, preference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 11 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SenSura Uro | Experimental | Device: SenSura UroThe test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive. |
| hollister Uro | Active comparator | Device: HollisterThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SenSura UroAlso: SenSura URO Standard Wear 1-piece bag, Product number:1438298The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive. | Device | SenSura Uro |
| HollisterAlso: Moderma Flex Urostomy, Cut-to-fit bag, flat adhesive., product id : 29100The 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 Uro |
Primary outcome
Preference of Sensura vs Moderma
Time frame: 4 weeks
Subjects were asked which of the tested products they preferred; SenSura or Moderma.
11 secondary outcomes
Immediate Adhesion
Time frame: 4 weeks
Removal of the Bag
Time frame: 4 weeks
Adhesion of the Bag During Use
Time frame: 4 weeks
Adhesives Ability to Absorb Perspiration
Time frame: 4 weeks
Flexibility of the Product
Time frame: 4 weeks
Awareness of the Presence of the Product
Time frame: 4 weeks
Feeling of Security During the Day
Time frame: 4 weeks
Feeling of Security During the Night
Time frame: 4 weeks
Problems With Splashing Sounds During Use
Time frame: 4 weeks
Bag Twisting During Night
Time frame: 4 weeks
Changes in Skin Compared to Before Study
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Katte, Stoma Nurse study chair
Ashford and St. Peters Hospital
Maureen Bridgland, Stoma Nurse principal investigator
Royal Sussex County Hospital
Caroline Rudoni, Stoma Nurse principal investigator
St. Georges Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SenSura Uro and Hollister in people with Urostomy, run by Coloplast A/S at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference of Sensura vs Moderma (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.