A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome
Stimuli Technology
Summary
The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult subjects aged 22 years or older and, * Diagnosed with OAB symptoms (characterized by urinary urgency, with or without UUI), * Symptoms persisting for at least 3 months, and * Documented with 2 or more urgency episodes per day (with or without incontinence) in two 3-day bladder diaries and, * With at least 11 or more voids per day (urinary frequency) documented in two 3-day bladder diaries * Willing and capable of providing informed consent * Capable of participating in all testing associated with this clinical investigation Exclusion Criteria: * Patients with pac…
Interventions
- DeviceTensi+
Transcutaneous Tibial Nerve Stimulation
Locations (3)
- Cedars-SinaiBeverly Hills, California
- NYU Langone HealthNew York, New York
- Toronto Western HospitalToronto