Phase 3
Completed N=37
Bladder Scan of Residual Urine With New Catheter
Source: ClinicalTrials.gov NCT01048541 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Mean Residual Urine Volume — 12.4; 9.4 mL
Summary
Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Residual Urine Volume |
12.4; 9.4 | — |
| SECONDARY The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) |
— | — |
| SECONDARY Median Absolute RU Volume |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject is a male IC user able to self-catheterise
- Subject has used hydrophilic-coated ICs for at least 1 month
- Subject is at least 18 years old.
- Subject has provided informed consent.
Exclusion Criteria
- Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).
- Subject has known abnormalities in the lower urinary tract.
Data sourced from ClinicalTrials.gov (NCT01048541). 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.