Stopped: Study was stopped due to issues with investigational device impacting its functionality and user handling. The sponsor decided to implement necessary design and/or material modifications to improve performance and safety before resuming recruitment.
This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.
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Patient experience for both types of catheterization
Timeframe: Through study completion, an average of 9 months
Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.
Timeframe: Day 28 after inclusion
Quantitively assessed self-perceived catheter-related experience
Timeframe: Day 28 after inclusion