NCT04547920

FREEOAB Study for Overactive Bladder

A Prospective Efficacy Study Comparing FREquency of Use and Efficacy of a Personalized Surgery-free Wearable and Personalized Bladder Modulation System With Objective Confirmation of Nerve Activation for Use in the Home by Subjects With OverActive Bladder Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Avation Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.

Conditions

• Overactive Bladder
• Urinary Frequency
• Urinary Incontinence, Urge
• Urinary Urgency

Interventions

Type	Name	Description
DEVICE	Wearable Bladder Modulation System	Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

Timeline

• Start date: 2021-01-11
• Primary completion: 2021-10-08
• Completion: 2023-06-15
• First posted: 2020-09-14
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study