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Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)
The ACCTUATE study: Assessment of CymActive™ Catheter Technology for UrinAry reTention and acceptancE study will evaluate a novel catheter design that addresses the specific needs of male long term catheter users living in the community. The primary endpoint of the study will be tolerability, assessed by measuring patient-reported Quality of Life and VAS pain scale assessments up to approximately day 90 (end of study). The secondary endpoints will be comparisons of the Adverse Event nature and frequency, up to approximately 90 days (end of study) and genomic profiling of the abundance and diversity of microorganisms present in the screening visit urine sample versus the end of study urine sample of participants from both arms of the trial.
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