A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 82
- Locations
- 16
- Primary Endpoint
- Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is Female
- •Is at least 18 years of age and has full legal capacity
- •Has signed an informed consent form
- •Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
- •Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
- •Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
- •Has the ability (assessed by investigator) and willingness to follow study procedures
Exclusion Criteria
- •Is participating in any other clinical study during this investigation
- •Has previously participated in this study
- •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)
- •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
- •Has any known allergies towards ingredients in the investigational device
- •Is pregnant
- •Is breastfeeding
Outcomes
Primary Outcomes
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
Time Frame: Tested at site visit after 14 days of device home use.
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 Outcomes
- Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)(Tested at site visit after 14 days of device home use.)
- Number of Flow-stops (Catheterisation Profile, Self-catheterisation)(Tested at site visit after 14 days of device home use.)
- Residual Volume at 1st Flow-stop(Tested at site visit after 14 days of device home use.)
- Average Residual Volume Post Catheterisation (Bladder Scan)(Tested at site visit after 14 days of device home use.)
- Number of Adverse Events(From Week 0-4)