NCT06956209

Akyva First In Human

A First-in-Human, Open-Label, Multicenter 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Iota Biosciences, Inc · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Underactive Bladder

Interventions

Type	Name	Description
DEVICE	Direct Bladder Wall Stimulation	The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination

Timeline

• Start date: 2025-09-24
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-05-04
• Last updated: 2026-02-09

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated device study