Neurogenic Bladder Dysfunction NosPhase 4NCT01523743
Quality of Life Intermittent Catheter Study
A Phase 4 study testing SpeediCath Compact in people with Neurogenic Bladder Dysfunction Nos, run by Coloplast A/S at 11 sites in 5 countries.
Trial summary
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder Dysfunction Nos
- What is being tested?
- SpeediCath Compact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Nov 2011to May 2012
- 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
- Is at least 18 years of age
- Has given written informed consent
- Has neurogenic bladder dysfunction
- Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
- Is able to self-catheterise
- Is able to use SpeediCath® compact catheters
- If spinal cord injury subject, injury must have occurred more than 12 months ago
- Covered by Social security system
Who cannot join
- Has used SpeediCath® compact catheters (not including screening for this investigation)
- Is admitted to rehabilitation centre
- Subjects using primarily catheter sets
- Is pregnant or breast-feeding
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
France4 sites
Hôpital Raymond Poincaré, Urology clinic
Garches, 92350
Hôpital Léon Berard, Rehabilitation clinic,
Hyères
Hôpital Tenon, Neuro-Urology and perineal explorations department,
Paris, Cedex 20
Hôpital Henry Gabrielle, Urology clinic,
Saint-Genis-Laval
Denmark3 sites
PrivatHospitalet Danmark, privat hospital,
Charlottenlund
Rigshospitalet, Urology clinic,
Copenhagen
CCBR Vejle, Clinical research site,
Vejle
Sweden2 sites
Gävle sjukhus, Urology clinic,
Gävle
Rehab Station Stockholm,
Stockholm
About this study
Official title: Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
- Conditions
- Neurogenic Bladder Dysfunction Nos
- Being tested
- SpeediCath Compact, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeediCath CompactDevice
Also called SpeediCath®Compact Male, for male participants, SpeediCath®Compact Female, for female participants
The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
Standard careDevice
The coated intermittent catheter normally used by subject
| Study group | Role | What they receive |
|---|---|---|
| Compact catheter | Experimental | Compact intermittent catheter Receives: Device: SpeediCath Compact |
| Standard Care | Active comparator | Standard Care: Coated intermittent catheter normally used by subject Receives: Device: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (0-100 Point)
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.
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 posted1 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionMay 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bladder Dysfunction NosStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Chartier-Kastler, Proff, Principal investigator, Hôpital Raymond poincarè, Service d'Urologie, Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523743
- Sponsor's protocol ID
- CP220
- Status last verified
- Aug 2016
- First submitted
- 9 Jan 2012
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
PubMed 34699062
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters
- ClinicalTrials.gov ID
- NCT01523743
- Acronym / sponsor ID
- CP220
- Conditions
- Neurogenic Bladder Dysfunction Nos
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compact catheter | Experimental | Device: SpeediCath CompactCompact intermittent catheter |
| Standard Care | Active comparator | Device: Standard careStandard Care: Coated intermittent catheter normally used by subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is at least 18 years of age
- Has given written informed consent
- Has neurogenic bladder dysfunction
- Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
- Is able to self-catheterise
Key exclusion criteria (4 listed)
- Has used SpeediCath® compact catheters (not including screening for this investigation)
- Is admitted to rehabilitation centre
- Subjects using primarily catheter sets
- Is pregnant or breast-feeding
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 |
|---|---|---|
| SpeediCath CompactAlso: SpeediCath®Compact Male, for male participants, SpeediCath®Compact Female, for female participantsThe SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra. | Device | Compact catheter |
| Standard careThe coated intermittent catheter normally used by subject | Device | Standard Care |
Primary outcome
Quality of Life (0-100 Point)
Time frame: 6 weeks
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34699062Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
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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.
Emmanuel Chartier-Kastler, Proff principal investigator
Hôpital Raymond poincarè, Service d'Urologie, Garches, France
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SpeediCath Compact in people with Neurogenic Bladder Dysfunction Nos, run by Coloplast A/S at 11 sites in 5 countries.
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 8 inclusion and 4 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Denmark, Sweden, Germany, Norway. 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 22 May 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?
Quality of Life (0-100 Point) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01523743, which also lists 1 linked publication.
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 30 Sep 2016.