N/A
N=73
A Confirmatory Study Confirming Performance of a New Intermittent Catheter
Urinary Retention
Bottom Line
View on ClinicalTrials.gov: NCT05485935 ↗Enrolled (actual)
73
Serious AEs
2.1%
Results posted
Mar 2025
Primary outcome: Primary: Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile — 18; 63.93 mL — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device - intermittent catheter with micro-hole zone (Device); Comparator - standard intermittent catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile |
18; 63.93 | 0.001 sig |
| PRIMARY Number of Flow-stop Episodes (HCP-led Catheterization) |
0.20; 1.32 | <0.001 sig |
| SECONDARY Number of Flow-stop Episodes (Self-led Catheterization) |
0.13; 0.96 | <0.001 sig |
| SECONDARY Residual Urine at 1st Flow Stop (Self-led Catheterization) |
8.2; 36.8 | 0.004 sig |
| SECONDARY Mean Red Blood Cell Concentration |
16.25; 19.77 | — |
| SECONDARY Positive Hematuria Event Post-catheterisation |
0.17; 0.19 | — |
Summary
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73)where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
Eligibility Criteria
Inclusion Criteria
- Male
- Was at least 18 years of age and had full legal capacity
- Had given written informed consent
- Had signed letter of authority (only DK)
- Had used clean intermittent self-catheterization (CISC) for at least the last 3 months
- Had used intermittent catheterization as the only bladder emptying method for at least the last 3 months
- Self-catheterized using Coloplast SpeediCath Flex or Hollister VaPro catheters, CH12 or CH14, for at least 3 months prior to inclusion
- Had the ability (assessed by investigator) and willingness to adhere to a 2-month study period
Exclusion Criteria
- Participation in any other clinical study during this investigation
- Previous participation in the study
- Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI)
- Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
- Any known allergies towards ingredients in the investigational device
Data sourced from ClinicalTrials.gov (NCT05485935). 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.