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 criteria¹

• IC for 3+ months​
• IC as only bladder emptying method applied​
• Neurogenic and non-neurogenic bladder dysfunction​
• No UTI symptoms at inclusion​
• SC Flex or Vapro user

Endpoints¹

Primary endpoints: Flow-stop episodes and residual volume at 1st flow-stop in IC by HCP​
Secondary endpoints: Flow-stop episodes, residual volume at 1st flow-stop, and haematuria (yes/no) in self IC​
Exploratory endpoints: Intra-catheter pressure, Residual volume w. BladderScanner, Discomfort, QoL, Perception, Haematuria grading​
Assessments: IC position, Urine volumes (at all flow-stops), dipstick haematuria/leukocyturia, ​
Assessments (DK-only): Labs on haematuria/leukocyturia, 17 biomarkers on inflammation, 2 cellular biomarkers

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.}