Tensi+ for Treating Overactive Bladder

September 8, 2026 updated by: Stimuli Technology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Toronto, Canada
        • Recruiting
        • Toronto Western Hospital
        • Principal Investigator:
          • Dean Elterman
        • Contact:
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Cedars-Sinai
        • Contact:
        • Principal Investigator:
          • Karyn Eilber
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Benjamin Brucker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tensi+ device to be delivered for use by patient
Device: Tensi+
Transcutaneous Tibial Nerve Stimulation
Sham Comparator: Identical Tensi+ Sham device to be delivered for use by patient
Device: Tensi+
Transcutaneous Tibial Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of urinary voids
Time Frame: 12 weeks
Percentage of responders in urinary frequency, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal
12 weeks
Urge urinary incontinence
Time Frame: 12 weeks
Percentage of responders in urge urinary incontinence, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal (0 events per day)
12 weeks
Overall Responder Rate Across OAB Symptoms
Time Frame: 12 weeks
Overall Responder rate defined as the percentage of responders who meet at least the responder criteria in one of the 3 symptoms of OAB, from baseline to Week 12 (urgency, frequency and UUI) from baseline
12 weeks
Quality of life measures
Time Frame: 12 weeks
Measured using the OAB-q Short Form (SF) questionnaire, which includes 19 questions scored from 1 ("none of the time") to 6 ("all of the time"). The total score ranges from 19 (best QOL) to 114 (worst QOL). A decrease in score from baseline to Week 12 indicates an improvement in quality of life.
12 weeks
Endurance of effect
Time Frame: 24 weeks
Maintenance of responder status from the primary endpoint (Week 12) through the last follow-up visit without relapse (Week 24), indicating a sustained treatment effect until the end-of-study visit.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stimuli Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-PF0001-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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