STUDY DESIGN: Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial. OBJECTIVES: When possible, intermittent catheterisation is the preferred method of bladder emptying for neurogenic bladder dysfunction. Hydrophilic-coated catheters have improved safety and ease of use, and a new compact catheter for men has been developed to improve discretion. METHODS: Participants self-catheterised at least four times daily for 14 days with a standard or compact catheter. The primary outcome measure was discomfort, using a visual analogue scale. Non-inferiority was defined as a difference in mean discomfort score of <0.9 cm. Other assessments included ease of use, discretion and the degree of pain, stinging or resistance. RESULTS: A total of 36 individuals participated and 30 were included in the intention-to-treat analysis. The mean difference between catheters for participant discomfort was -0.347 cm (95% confidence intervals: -1.493, 0.800). There were significant differences (P≤0.0001) in favour of the compact catheter for disposal and discretion, and inserting, storing, carrying and controlling the catheter. Fewer participants experienced resistance with the compact catheter. Participants were less likely to touch the coated part of the compact catheter. One adverse event was reported for each catheter. CONCLUSIONS: The coated compact catheter is at least as acceptable to the user as the standard catheter, with no inferiority observed in the level of discomfort. Secondary endpoints suggest that there are advantages of using the compact catheter, particularly with regard to discretion and ease of use. SETTING: France/Denmark.
RCT Entities:
STUDY DESIGN: Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial. OBJECTIVES: When possible, intermittent catheterisation is the preferred method of bladder emptying for neurogenic bladder dysfunction. Hydrophilic-coated catheters have improved safety and ease of use, and a new compact catheter for men has been developed to improve discretion. METHODS:Participants self-catheterised at least four times daily for 14 days with a standard or compact catheter. The primary outcome measure was discomfort, using a visual analogue scale. Non-inferiority was defined as a difference in mean discomfort score of <0.9 cm. Other assessments included ease of use, discretion and the degree of pain, stinging or resistance. RESULTS: A total of 36 individuals participated and 30 were included in the intention-to-treat analysis. The mean difference between catheters for participant discomfort was -0.347 cm (95% confidence intervals: -1.493, 0.800). There were significant differences (P≤0.0001) in favour of the compact catheter for disposal and discretion, and inserting, storing, carrying and controlling the catheter. Fewer participants experienced resistance with the compact catheter. Participants were less likely to touch the coated part of the compact catheter. One adverse event was reported for each catheter. CONCLUSIONS: The coated compact catheter is at least as acceptable to the user as the standard catheter, with no inferiority observed in the level of discomfort. Secondary endpoints suggest that there are advantages of using the compact catheter, particularly with regard to discretion and ease of use. SETTING: France/Denmark.