- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557787
Investigation of Non-CE Marked Intermittent Catheters for Females
Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Female Users of Intermittent Catheters
Study Overview
Status
Conditions
Detailed Description
The CP324 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 15 female IC users.
For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Urologisk klinik, Afsnit 2112, Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female
- Minimum 18 years of age and with full legal capacity
- Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
- Ability to self-catheterize
- Written informed consent, signed letter of authority and signed secrecy agreement given
Exclusion Criteria:
- Breastfeeding
- Pregnancy (based on pregnancy test - urine)
- Participation in any other clinical study during this investigation
- Symptoms of urinary tract infection as judged by the investigator
- Any know allergies towards ingredients in the products
- Relevant medical history that would prevent the subject from participation (investigators judgement)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intermittent catheter; SpeediCath® Standard female
Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day.
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Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard female.
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Experimental: New intermittent catheter Variant 1 for females
Participants underwent two catheterizations with the new intermittent catheter variant 1 for females: The first was performed by a trained nurse, the second by the participant later the same day.
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Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
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Experimental: New intermittent catheter Variant 2 for females
Participants underwent two catheterizations with the new intermittent catheter variant 2 for females: The first was performed by a trained nurse, the second by the participant later the same day.
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Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual Urine at 1st Flow-stop During Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination.
This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter.
Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
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Immediately after the procedure/catheterization, up to 5 min.
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Residual Urine at 1st Flow-stop During Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
The residual urine at 1st flow-stop during self-catheterization (i.e., catheterization performed by the participant) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination.
This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter.
Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-void Residual Urine After Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 15 min.
|
The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.
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Immediately after the procedure/catheterization, up to 15 min.
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Post-void Residual Urine After Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 15 min.
|
The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner.
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Immediately after the procedure/catheterization, up to 15 min.
|
Insertion Discomfort During Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured at catheter insertion (performed by nurse), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
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Immediately after the procedure/catheterization, up to 5 min.
|
Urination Discomfort During Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured during catheter urination/emptying (performed by nurse), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Withdrawal Discomfort During Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured during catheter withdrawal (performed by nurse), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Overall Discomfort During Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Insertion Discomfort During Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured at catheter insertion (performed by participant), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Urination Discomfort During Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured during catheter urination/emptying (performed by participant), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Withdrawal Discomfort During Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured during catheter withdrawal (performed by participant), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Overall Discomfort During Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
Discomfort measured for the entire catheterization procedure (performed by participant), using the Visual Analogue Scale (VAS).
The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g.
discomfort/pain.
It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm).
The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced.
A high score reflects a worse outcome than a lower score.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Per Bagi, MD, Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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