Ireland
--:--IST
Recruiting Not applicable

Tensi+ for Treating Overactive Bladder

NCT07300904 · tracked via the Priya Life Science USA tracker
Sponsor
Stimuli Technology
Phase
Not applicable
Started
2026-05-26
Last updated
2026-09-11

Condition(s) studied

Overactive Bladder (OAB)

Investigational drug(s) / intervention(s)

Tensi+

Tensi+: Transcutaneous Tibial Nerve Stimulation

Study 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

Sex
ALL
Min age
22 Years
Max age
—
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 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 outcome measure(s)

  • Treatment success — 12 weeks
    Percentage of responders in urgency events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline to Week 12, in total urgency events per day, or returns to normal (0 events per day) at Week 12. This endpoint will be evaluated through 3-day bladder diaries.

Trial sites (3)

FacilityCityRegionStatus
Cedars-Sinai Beverly Hills California Recruiting
NYU Langone Health New York New York Recruiting
Toronto Western Hospital Toronto Canada Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07300904 on ClinicalTrials.gov ↗ ← All trials in the USA