NCT05381116

A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder

A Prospective, Sham-Controlled, Safety and Efficacy Study of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Modulation and Digital Health System With Objective Confirmation of Nerve Activation for Use in Home by Subjects With Overactive Bladder Syndrome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Avation Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.

Conditions

• Overactive Bladder
• Urinary Urge Incontinence
• Urge Incontinence

Interventions

Type	Name	Description
DEVICE	Avation System	Subjects will perform therapy with active Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, eligible Subjects from the Active Arm will be offered the opportunity to participate in the additional twenty one (21) month Open-Label Phase.
DEVICE	Sham Avation System	Subjects will perform therapy with sham Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, all Subjects from the Sham Arm will be offered the opportunity to crossover and participate in the additional twenty one (21) month Open-Label Phase.

Timeline

• Start date: 2022-04-14
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-05-19
• Last updated: 2024-05-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study