Urostomy PatentPhase 3NCT00761748
Comparison of Two Urostomy Bags (2-piece).
A Phase 3 study testing Convatec Uro 2-piece and SenSura Uro 2-piece in people with Urostomy Patent, run by Coloplast A/S at 1 site in Germany.
Trial summary
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urostomy Patent
- What is being tested?
- Convatec Uro 2-piece and SenSura Uro 2-piece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Feb 2009
- Phase
- Phase 3
- 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
- Be at least 18 years old,
- Be able to complete a written consent form
- Be able to fill in the Case Report Form
- Have a urostomy with a diameter of 33 mm. or less.
- Have had the urostomy for 3 months or more.
- Use a 2-piece convex (or convex light) normally.
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- Be able to use SenSura URO 2-piece product
- Be able to use ConvaTec, 2-piece product
- Be able to handle the product themselves (application, removal and emptying),
Who cannot join
- In order to be enrolled in the clinical investigation, the subjects must not:
- Need to use an ostomy belt
- Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
- 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
1 site in 1 country.
About this study
Official title: A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Read the detailed description
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
- Conditions
- Urostomy Patent
- Being tested
- Convatec Uro 2-piece, SenSura Uro 2-piece
- Keywords
- Urostomy,, 2-piece,, preference,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convatec Uro 2-pieceDevice
Also called ConvaTec 2-piece
Specific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'.
The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look.
SenSura Uro 2-pieceDevice
Also called SenSura
SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
| Study group | Role | What they receive |
|---|---|---|
| SenSura | Experimental | SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. Receives: Device: SenSura Uro 2-piece |
| Convatec | Active comparator | Convatec Uro 2-piece Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. Receives: Device: Convatec Uro 2-piece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of the Two Urostomy Products
Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.
The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionFeb 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 Urostomy PatentStudies 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Carter, M.Sc, Study chair, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761748
- Sponsor's protocol ID
- DK189OS
- Status last verified
- Nov 2012
- First submitted
- 26 Sep 2008
- Last updated
- 1 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany
- ClinicalTrials.gov ID
- NCT00761748
- Acronym / sponsor ID
- DK189OS
- Conditions
- Urostomy Patent
- Keywords
- Urostomy,, 2-piece,, preference,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 1 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Detailed description
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SenSura | Experimental | Device: SenSura Uro 2-pieceSenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. |
| Convatec | Active comparator | Device: Convatec Uro 2-pieceConvatec Uro 2-piece Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be at least 18 years old,
- Be able to complete a written consent form
- Be able to fill in the Case Report Form
- Have a urostomy with a diameter of 33 mm. or less.
- Have had the urostomy for 3 months or more.
Key exclusion criteria (6 listed)
- In order to be enrolled in the clinical investigation, the subjects must not:
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 |
|---|---|---|
| Convatec Uro 2-pieceAlso: ConvaTec 2-pieceSpecific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'. The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look. | Device | Convatec |
| SenSura Uro 2-pieceAlso: SenSuraSenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm) | Device | SenSura |
Primary outcome
Preference of the Two Urostomy Products
Time frame: 6 weeks
Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
- 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.
Daniel Carter, M.Sc study chair
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Convatec Uro 2-piece and SenSura Uro 2-piece in people with Urostomy Patent, run by Coloplast A/S at 1 site in Germany.
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 9 inclusion and 6 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 1 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 Jan 2013). 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 the Two Urostomy Products (time frame: 6 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 1 Jan 2013.