Clinical Trial of New Intermittent Single-use Catheter
Study Details
Study Description
Brief Summary
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational device - newly developed intermittent catheter Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. |
Device: Investigational device - newly developed intermittent catheter
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.
|
| Active Comparator: Comparator device (#1 OR #2) SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. |
Device: Comparator device #1 - SpeediCath Eve
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
Device: Comparator device #2 - SpeediCath Compact Plus Female
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
|
Outcome Measures
Primary Outcome Measures
- Residual volume at 1st flow-stop (catheterisation performed by HCP) [Week 2 and 4]
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Secondary Outcome Measures
- Number of flow-stops (catheterisation profile, catheterisation performed by HCP) [Week 2 and 4]
Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)
- Number of flow-stops (catheterisation profile, self-catheterisation) [Week 2 and 4]
Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)
- Residual volume at 1st flow-stop [Week 2 and 4]
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)
- Average residual volume post catheterisation (bladder scan) [Week 2 and 4]
Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)
- Number of Adverse events [From Week 0-4]
Number of Adverse events (number)
Other Outcome Measures
- Exploratory: Perception questionnaire [Week 2 and 4]
Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit
Eligibility Criteria
Criteria
Inclusion Criteria:
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Is Female
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Is at least 18 years of age and has full legal capacity
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Has signed an informed consent form
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Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
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Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
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Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
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Has the ability (assessed by investigator) and willingness to follow study procedures
Exclusion Criteria:
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Is participating in any other clinical study during this investigation
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Has previously participated in this study
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Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
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Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
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Has any known allergies towards ingredients in the investigational device
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Is pregnant
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Is breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshopsitalet | Copenhagen | København Ø | Denmark | 2100 |
| 2 | Sanos Clinic | Gandrup | Nordjylland | Denmark | 9362 |
| 3 | Odense Universitetshospital | Odense | Denmark | 5000 | |
| 4 | Sanos Clinic Vejle | Vejle | Denmark | 7100 | |
| 5 | Hôpital Saint- Philibert | Lille | France | ||
| 6 | Hôpital Tenon | Paris | France | 75020 | |
| 7 | CHU Toulouse Rangueil | Toulouse | France | ||
| 8 | Synexus Birmingham | Birmingham | United Kingdom | ||
| 9 | North Bristol NHS Trust | Bristol | United Kingdom | ||
| 10 | Addenbrookes | Cambridge | United Kingdom | ||
| 11 | Synexus Merseyside | Liverpool | United Kingdom |
Sponsors and Collaborators
- Coloplast A/S
Investigators
- Principal Investigator: Karin Andersen, MD, Odense Universitetshospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP348