FREEOAB Study for Overactive Bladder
NCT04547920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2025-02-26
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
- DEVICE
-
Wearable Bladder Modulation System
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device
Sponsors & Collaborators
-
Avation Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-11
- Primary Completion
- 2021-10-08
- Completion
- 2023-06-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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