RecruitingNot ApplicableNCT06956209

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

Sponsor

Iota Biosciences, Inc

Enrollment

15 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

Underactive Bladder

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Direct Bladder Wall Stimulation for people with underactive bladder. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDirect Bladder Wall Stimulation

The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination

Locations(2)

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Australian Prostate Centre

Melbourne N., Victoria, Australia

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NCT06956209