19Apr 2022
Muscarinic‐3‐receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial

Muscarinic‐3‐receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial

This study aims to evaluate the safety and efficacy of ASP8302, a novel positive allosteric modulator for the muscarinic M3 receptor (M3‐PAM), in patients with underactive bladder (UAB). A randomized, double‐blind, placebo‐controlled multicenter study was performed in adult male/female subjects with UAB, defined as incomplete bladder emptying (postvoid residual volume [PVR] > 100 ml) without significant bladder outlet obstruction and/or overactive bladder. One hundred and thirty‐five patients were randomized (ASP8302 group: 65 patients, placebo group: 70 patients). In males, functional and symptomatic outcomes improved. Urinary incontinence episodes/24 h decreased in males with preexisting incontinence. ASP8302 was safe and well tolerated in patients with UAB identified by nonurodynamic clinical criteria, but it did not show efficacy in the primary endpoint. However, in males, it showed improvement in symptoms and functional parameters. BVE (using US) is a more optimal outcome measure than PVR in UAB.

  • #urology

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