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Tensi+ for Treating Overactive Bladder

Recruiting

A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome

Who can join

Ages 22 and older · All sexes

Full eligibility criteria
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 pacemakers or implanted defibrillators or any other implanted electronic device
* Patients prone to excessive bleeding
* Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function
* Patients who are pregnant or planning to become pregnant while using this product
* Patients with ankle joint problems, ankle oedema or dermatological oedema in the area where the electrodes should be placed
* Patients wearing a metal implant near the stimulated area
* Patient with cognitive deficiency
* Administration of intravesical injection of botulinum toxin within 12 months of study enrollment, or treatment within the previous year with other forms neuromodulation for OAB
* Patients treated with medical therapy OAB treatment washout inferior to 30 days
* Patients with diabetic neuropathy
* Patients with uncontrolled diabetes and HbA1c levels above 7%
* Guillain-Barré syndrome
* Chronic inflammatory demyelinating polyneuropathy (CIDP)
* Multiple sclerosis
* A primary diagnosis of stress urinary incontinence (SUI)
* Patients with recurrent rrinary tract infections (UTIs) defined as more than 2 episodes per year, or with any baseline lower urinary tract pathology identified at the time of the 3-day bladder diary assessment.
* Currently participating in another clinical trial

About the study

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.

What is being tested

Sponsor: Stimuli Technology · Participants: 60 · Started: May 26, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07300904

Locations in the U.S.

CaliforniaCedars-Sinai, Beverly Hills
New YorkNYU Langone Health, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.