Spinal Cord InjuriesNCT03337048
Exploratory Study Investigating Urodynamic Parameters During Catheterisation
A study testing SpeediCath in people with Spinal Cord Injuries and Enlarged Prostate With Lower Urinary Tract Symptoms, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Enlarged Prostate With Lower Urinary Tract Symptoms
- What is being tested?
- SpeediCath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Nov 2017to 29 May 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be male
- For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit
- For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture
- For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months
Who cannot join
- Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)
- Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination)
- For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.
Read the detailed description
The investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with SCI and 10 patients with BPH.
The healthy volunteers included into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard IC (4-15 days after visit 1). (Visit 0 and visit 1 can be the same day).
The subjects with SCI and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (Most IC users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). The second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard IC (4-15 days after visit 0 while subject is on prophylaxis antibiotics).
The investigation is conducted at one site and is an explorative study, estimated to last eight (8) months.
Due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.
- Being tested
- SpeediCath
- 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.
SpeediCathDevice
SpeediCath is a standard intermittent catheter that is on the market.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of endpoints | Experimental | In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter.
In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter. Receives: Device: SpeediCath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort During Catheter Insertion on a Visual Analogue Scale
On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome.
Measured: Filled out after 5 minutes per catheterisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start30 Nov 2017
- Primary completion29 May 2018
- Study completion29 May 2018
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
- Not applicable
- Intervention model
- Single group
- 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
- Nazarena Mazarro, Study director, Vice president Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337048
- Sponsor's protocol ID
- CP277
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2017
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Investigating Urodynamic Parameters During Catheterisation
- ClinicalTrials.gov ID
- NCT03337048
- Acronym / sponsor ID
- CP277
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 12 Aug 2024
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 the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.
Detailed description
The investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with SCI and 10 patients with BPH.
The healthy volunteers included into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard IC (4-15 days after visit 1). (Visit 0 and visit 1 can be the same day).
The subjects with SCI and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (Most IC users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). The second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard IC (4-15 days after visit 0 while subject is on prophylaxis antibiotics).
The investigation is conducted at one site and is an explorative study, estimated to last eight (8) months.
Due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of endpoints | Experimental | Device: SpeediCathIn healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter. In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be male
- For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit
- For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture
Key exclusion criteria (3 listed)
- Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)
- Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination)
- For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract
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 |
|---|---|---|
| SpeediCathSpeediCath is a standard intermittent catheter that is on the market. | Device | Measurement of endpoints |
Primary outcome
Discomfort During Catheter Insertion on a Visual Analogue Scale
Time frame: Filled out after 5 minutes per catheterisation.
On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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.
Nazarena Mazarro study director
Vice president Medical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpeediCath in people with Spinal Cord Injuries and Enlarged Prostate With Lower Urinary Tract Symptoms, 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 6 inclusion and 3 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 12 Aug 2024. 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 12 Aug 2024). 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?
Discomfort During Catheter Insertion on a Visual Analogue Scale (time frame: Filled out after 5 minutes per catheterisation.). 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 12 Aug 2024.