At a glance
ClinicalIndex Comparison RecordN/ACompleted· 96 enrolled
Drug / intervention
Wearable Bladder Modulation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Wearable Bladder Modulation System for Overactive Bladder and 3 related conditions. Completed, enrolled 96 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartJan 2021
Primary CompletionOct 2021
Study CompletionJun 2023
TodayJul 2026
First PostedSep 14, 2020
Enrollment StartJan 11, 2021
Primary CompletionOct 8, 2021
Study CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago
Interventions
Wearable Bladder Modulation Systemdevice
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device