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ClinicalTrials.gov ID

NCT07300904

Lead Sponsor

Stimuli TechnologyINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Apr 28, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

Official Title

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

Brief 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.

• Overactive Bladder (OAB)

• Tensi+

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Stimuli TechnologyINDUSTRY

benjamin.brucker@nyulangone.org646-825-6324

Dean.Elterman@uhn.ca416 603 5800 ext. ext. 5033