N/A
N=73
Clinical Trial of New Single-use Compact Intermittent Catheter
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05841004 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) — 15.3; 23.7 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device (Device); Comparator device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Coloplast A/S
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) |
15.3; 23.7 | — |
| SECONDARY Number of Flowstops (Catheterisation Performed by a Healthcare Professional) |
0.27; 0.59 | — |
| SECONDARY Residual Volume Post Catheterisation |
10.1; 15.8 | — |
| SECONDARY Number of Adverse Events |
1; 1 | — |
Summary
The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.
The total study duration for the individual subject will be up to 14 days.
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 or is able to use a compact catheter assessed by investigator
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 (NCT05841004). 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.