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Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial

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

NCT07300904•Stimuli Technology

View on ClinicalTrials.gov

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

22 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (3)

Cedars-Sinai

Beverly Hills, California, United States

NYU Langone Health

New York, New York, United States

Toronto Western Hospital

Toronto, Canada

Key Dates

Start Date

March 1, 2026

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Overactive Bladder (OAB)

Interventions

Tensi+

DEVICE

Contacts

Akshaya Mariadassou

CONTACT

+331 84 60 48 25 a.mariadassou@stimuli-technology.com

Sarah Todeschini

CONTACT

+331 84 60 48 25 s.todeschini@stimuli-technology.com

INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407

Overactive Bladder (OAB)

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RECRUITINGNA

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

NCT07195656

Overactive Bladder (OAB)

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ENROLLING_BY_INVITATIONNA

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial

Inclusion Criteria

Exclusion Criteria

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.

BlueWind RENOVA iStim™ System for the Treatment of OAB

Cefar URO - Symptomatic Treatment of Overactive Bladder