N/A
Completed N=30
Investigation of New Intermittent Catheters in Healthy Volunteers
Retention, Urinary
Source: ClinicalTrials.gov NCT04445051 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Residual Urine at 1st Flow-stop — 35.0; 1.1; 0.2; 37.0 mL — p=0.010
Summary
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Urine at 1st Flow-stop |
35.0; 1.1; 0.2; 37.0; 2.2; 1.0 | 0.010 sig |
| SECONDARY Post-void Residual Urine |
8.6; 1.5; 27.6; 5.3; 24.3; 16.3 | 0.665 |
| SECONDARY Catheterization Insertion Discomfort |
0.51; 0.81; 0.86; 2.32; 2.31; 2.79 | 0.615 |
| SECONDARY Catheterization Urination Discomfort |
0.18; 0.47; 0.55; 0.93; 0.74; 1.51 | 0.639 |
| SECONDARY Withdrawal Discomfort |
0.79; 0.83; 1.11; 2.05; 1.42; 2.28 | 0.798 |
| SECONDARY Overall Catheterization Discomfort |
0.66; 0.72; 1.04; 1.99; 1.71; 2.58 | 0.882 |
| SECONDARY Post-catheterization Urination Discomfort |
0.29; 0.09; 0.35; 0.66; 0.66; 1.88 | 0.877 |
Eligibility Criteria
Inclusion Criteria
- Minimum 18 years of age and with full legal capacity
- Written informed consent and signed letter of authority and secrecy agreement given
- Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
- Urine Multistix negative for erythrocytes (hematuria)
Exclusion Criteria
- Participation in any other clinical investigations during this investigation
- Known hypersensitivity towards any of the test products
- Symptoms of urinary tract infection (UTI) (Investigators judgement)
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT04445051). 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. Informational only — not medical advice.