N/A
N=81
Clinical Trial of New Intermittent Single-use Catheter
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05814211 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) — 23.22; 15.87 milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device - newly developed intermittent catheter (Device); Comparator device #1 - SpeediCath Eve (Device); Comparator device #2 - SpeediCath Compact Plus Female (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Coloplast A/S
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) |
23.22; 15.87 | — |
| SECONDARY Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP) |
0.21; 0.57 | — |
| SECONDARY Number of Flow-stops (Catheterisation Profile, Self-catheterisation) |
0.28; 0.71 | — |
| SECONDARY Residual Volume at 1st Flow-stop |
19.88; 27.77 | — |
| SECONDARY Average Residual Volume Post Catheterisation (Bladder Scan) |
4.8; 12.0; 7.7; 9.3 | — |
| SECONDARY Number of Adverse Events |
10; 13 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05814211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.