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Tensi+ for Overactive Bladder

This study is looking into how safe and effective the Tensi+ device is for treating Overactive Bladder (OAB) symptoms. OAB can cause frequent urination, a sudden strong need to urinate (urgency), and sometimes accidental leaks (urge urinary incontinence). Tensi+ uses Transcutaneous Tibial Nerve Stimulation, which involves gentle electrical stimulation through the skin. You might be able to join if you are 22 or older, have OAB symptoms for at least 3 months, and experience at least two urgency episodes and 11 or more urinations per day. The main goal is to see if the treatment is successful after 12 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. The study will evaluate the Tensi+ device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for treatment success is measured at 12 weeks.

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NCT07300904

Tensi+ for Treating Overactive Bladder

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Stimuli Technology
~60 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Tensi+

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment success
Measured over 12 weeks

Conditions

Overactive Bladder (OAB)

Explore related trials

Overactive Bladder

Where it's being run

3 sites across 3 states
California1
New York1
Canada1

Who to contact

Akshaya Mariadassou
[email protected]
+331 84 60 48 25
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Treatment success12 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.