Urinary IncontinencePhase 4NCT01056666
Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
A Phase 4 study testing Conveen Optima is a urisheath to be used together with a collecting bag for urine and absorbent protection in people with Urinary Incontinence, run by Coloplast A/S.
Trial summary
The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Conveen Optima is a urisheath to be used together with a collecting bag for urine and absorbent protection
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18
- Out clinic patient
- Patient using absorbent protection for his urinary incontinence
- Moderate to severe urinary incontinence (1 hour pad test > 10g)
- All kind of stable urinary incontinence
- Patient able to apply himself the device
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- Patient able to understand the questions
- Patient having given his informed consent
- Patient whose overall treatment for his urinary incontinence is not modified during the study
Who cannot join
- Patient having a retracted penis
- Patient having skin problem on the penis
- Patient using urisheaths
- Bedridden patient
- Institutionalized patient
- Patient with indwelling catheter or under intermittent catheterisation
- Patient with fecal incontinence leading to the use of absorbent protection
- Patient suffering of urinary tract infection
About this study
Official title: Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle
The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.
- Conditions
- Urinary Incontinence
- Being tested
- Conveen Optima is a urisheath to be used together with a collecting bag for urine, absorbent protection
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conveen Optima is a urisheath to be used together with a collecting bag for urineDevice
Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis
absorbent protectionDevice
The patient use his usual absorbent protection (same brand), and change it when needed
| Study group | Role | What they receive |
|---|---|---|
| Conveen optima urisheaths | Experimental | Not described Receives: Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine |
| absorbent protections | Placebo comparator | The patient use their usual absorbent protection as comparator. All brands are allowed. Receives: Device: absorbent protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on quality of life
Measured: Days 0, 15, 30
Secondary outcomes (1)
Efficacy (leakages)
Measured: days 13, 14, 15 and days 28, 29, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Costa, Professor, Principal investigator, Hôpital Caremeau Nimes. France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056666
- Sponsor's protocol ID
- FR002CC
- Status last verified
- Apr 2007
- First submitted
- 25 Jan 2010
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle
- ClinicalTrials.gov ID
- NCT01056666
- Acronym / sponsor ID
- FR002CC
- Conditions
- Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conveen optima urisheaths | Experimental | Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine |
| absorbent protections | Placebo comparator | Device: absorbent protectionThe patient use their usual absorbent protection as comparator. All brands are allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient over 18
- Out clinic patient
- Patient using absorbent protection for his urinary incontinence
- Moderate to severe urinary incontinence (1 hour pad test > 10g)
- All kind of stable urinary incontinence
Key exclusion criteria (8 listed)
- Patient having a retracted penis
- Patient having skin problem on the penis
- Patient using urisheaths
- Bedridden patient
- Institutionalized patient
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 |
|---|---|---|
| Conveen Optima is a urisheath to be used together with a collecting bag for urineConveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis | Device | Conveen optima urisheaths |
| absorbent protectionThe patient use his usual absorbent protection (same brand), and change it when needed | Device | absorbent protections |
Primary outcome
Impact on quality of life
Time frame: Days 0, 15, 30
1 secondary outcome
Efficacy (leakages)
Time frame: days 13, 14, 15 and days 28, 29, 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
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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.
Pierre Costa, Professor principal investigator
Hôpital Caremeau Nimes. France
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conveen Optima is a urisheath to be used together with a collecting bag for urine and absorbent protection in people with Urinary Incontinence, run by Coloplast A/S.
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 8 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 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact on quality of life (time frame: Days 0, 15, 30). 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 19 Sep 2011.