Tolerability And Safety Of Urotainer® Polihexanide 0.02% In Long-Term Catheterized Patients: A Prospective Cohort Study [post]

2020 unpublished
In patients with long-term indwelling bladder catheters, bacterial colonization is inevitable, leading to urinary tract infections or encrustations with subsequent catheter blockage. Currently, bladder irrigations are the most frequently used prophylactic means, but the best solution remains yet to be determined. In vitro studies demonstrate that polihexanide is a promising option for catheter irrigation, but no data about safety and tolerability exist. Methods: In a prospective observational
more » ... udy in patients with long-term (> 2 weeks) indwelling bladder catheter, a 0.02% polihexanide solution was used to rinse the catheter on five consecutive days. Adverse events, tolerability and vital signs were assessed before, during, after and at the end of the treatment period. Results: There was no serious adverse event in the study. A total of 28 adverse events (AEs) in 15 (46.88%) participants were experienced. Absolute changes in pain scores were not clinically relevant. No incidences of either flushing or sweating were found during instillation. Bladder spasms during instillation were reported in two cases during a single instillation. Mean pulse rates did not change by more than 3 beats per minute. Mean changes in body temperature did not exceed 0.12 °C. Clinically relevant changes in blood pressure were recorded for 3 patients. Conclusions: This is the first study to demonstrate that a 0.02% polihexanide solution can safely be used for catheter Irrigation. Background Despite recent advances in urologic diagnostics and treatment, a significant group of patients has to rely on long-term indwelling urinary catheters, either due to urinary retention, urinary incontinence, neurogenic lower urinary tract dysfunction or due to
doi:10.21203/rs.2.21999/v1 fatcat:igdjgdbprve2taire4hqcnepv4