A first-in-human, open-label, multicentre study evaluating the safety and efficacy of an implantable device for direct bladder wall stimulation in participants with lower urinary tract symptoms of underactive bladder.
This first-in-human clinical trial is evaluating the AKYVA System, an active implantable device designed to deliver simulation directly to the anterior-lateral bladder wall to initiate detrusor contraction and allow bladder emptying.
This study is targeting patients with underactive bladder symptoms related to non-obstructive urinary retention who rely on clean intermittent catheterisations to void.
