A multi-centre randomised controlled study confirming the improved performance with a new Micro-hole zone catheter in a population of adult male intermittent catheter users
PDF
1
page
Get full access with a free account
Benefits of the Coloplast® Professional Educational platform
Full access to educational content, events and resources
Track your progress
Share content with your colleagues
Share supporting material with your patient
Confirmatory Mode of Action in Male IC users1
Objectives: To demonstrate superiority of Luja over 2-eyelet catheters in terms of number of flow-stop episodes, residual volume and frequency of positive haematuria.
Population: 72 Male IC users (Vapro/SC Flex users)
Key eligibility criteria for recruitment to trial 1
- SC as only bladder emptying method applied
- Neurogenic and non-neurogenic bladder dysfunction
- No UTI symptoms at inclusion
- Currently using a sleeved ISC catheter
Endpoints1
Primary endpoints: Flow-stop episodes and residual volume at 1st flow-stop in ISC by HCP
Secondary endpoints: Flow-stop episodes, residual volume at 1st flow-stop, and haematuria (yes/no) in self ISC
Exploratory endpoints: Intra-catheter pressure, Residual volume w. Bladder Scanner, Discomfort, QoL, Perception, Haematuria grading
Assessments: ISC position, Urine volumes (at all flow-stops), dipstick haematuria/leukocyturia,
The Micro-hole Zone Technology catheter is superior to comparator§ in terms of1
Additionally the following perceptions were obtained by users:1
- Less blocking sensation: Significantly less blocking sensation compared with a conventional eyelet catheter (p<0.001).
- More confidence at first flow-stop: Significantly more confident that their bladder is completely empty when the urine flow stops compared to a conventional eyelet catheter (p=0.003).
- Easier emptying: Significantly easier to completely empty the bladder compared with a conventional eyelet catheter (p=0.004).
*Statistically confirmed at p < 0.001
§ SpeediCath Flex was the comparator product in 98% of the catheterizations by HCPs and in all self-catheterizations.
†The last flow-stop is considered equal to end of catheterisation and therefore discounted from the total number of flow-stops. Hence, catheterisations with a single flow-stop are reported as having no flow-stops.