Spinal Cord InjuriesNCT02230540
Intermittent Catheterization in Spinal Cord Injured Men
A study testing SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+ and Product B SelfCath and urine bag, Conveen Contour in people with Spinal Cord Injuries, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+ and Product B SelfCath and urine bag, Conveen Contour
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Sep 2014
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has given written informed consent
- Is at least 18 years of age and has full legal capacity
- Is a male
- Has an Spinal Cord Injury diagnosis
Who cannot join
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Known hypersensitivity toward any of the test products
- Serious abdominal scars
- Symptoms of urinary tract infections
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
- Conditions
- Spinal Cord Injuries
- Being tested
- SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+, Product B SelfCath and urine bag, Conveen Contour
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelfCath (comparator)Device
Commercially available CE-marked catheter for urinary drainage.
Product A SelfCath and urine bag, Conveen Security+Device
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Product B SelfCath and urine bag, Conveen ContourDevice
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions. Measurement of residual urine at different positions. Receives: Device: SelfCath (comparator); Device: Product A SelfCath and urine bag, Conveen Security+ |
| Sequence B | Experimental | Based on results from sequence A, sequence B may or may not be initiated.
Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product B in different positions. Measurement of residual urine at different positions. Receives: Device: SelfCath (comparator); Device: Product B SelfCath and urine bag, Conveen Contour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Volume Less Than 100ml
The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume <100ml" to "collected volume > 200ml", were used to interpret the primary endpoint.
Measured: 2-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionSep 2014
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 Spinal Cord InjuriesStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Bagi, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230540
- Sponsor's protocol ID
- CP250
- Status last verified
- Feb 2016
- First submitted
- 28 Aug 2014
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Catheterization in Spinal Cord Injured Men
- ClinicalTrials.gov ID
- NCT02230540
- Acronym / sponsor ID
- CP250
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Device: SelfCath (comparator), Device: Product A SelfCath and urine bag, Conveen Security+Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions. |
| Sequence B | Experimental | Device: SelfCath (comparator), Device: Product B SelfCath and urine bag, Conveen ContourBased on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has given written informed consent
- Is at least 18 years of age and has full legal capacity
- Is a male
- Has an Spinal Cord Injury diagnosis
Key exclusion criteria (4 listed)
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Known hypersensitivity toward any of the test products
- Serious abdominal scars
- Symptoms of urinary tract infections
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 |
|---|---|---|
| SelfCath (comparator)Commercially available CE-marked catheter for urinary drainage. | Device | Sequence A, Sequence B |
| Product A SelfCath and urine bag, Conveen Security+SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices). | Device | Sequence A |
| Product B SelfCath and urine bag, Conveen ContourSelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices). | Device | Sequence B |
Primary outcome
Residual Volume Less Than 100ml
Time frame: 2-4 hours
The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume <100ml" to "collected volume > 200ml", were used to interpret the primary endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- 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.
Per Bagi, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+ and Product B SelfCath and urine bag, Conveen Contour in people with Spinal Cord Injuries, run by Coloplast A/S at 1 site in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 15 Mar 2016. 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 Denmark. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2016). 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?
Residual Volume Less Than 100ml (time frame: 2-4 hours). 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 15 Mar 2016.