A Confirmatory Study Confirming Performance of a New Intermittent Catheter

A multi-centre, randomised, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3, catheterisations were performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a home-use test period, followed by visit 3 which terminated the study.