The goal of this study is to check if the study device, the Akyva System, is safe to use and to find out if it has any possible side effects. Researchers will see if the study device can help you urinate without the need for catheterization, which involves passing a catheter (small tube) into the bladder, and if there is improvement in the leftover urine amount in your bladder after urinating or trying to urinate.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To characterize the safety of implantation and use of the Akyva System
Timeframe: From enrollment to the end of the treatment at 18 months
To characterize the safety of implantation and use of the Akyva System
Timeframe: From enrollment to the end of the treatment at 18 months