Tensi+ for Treating Overactive Bladder
Starting soon · Not applicable · Has a placebo group
Conditions studied: Overactive Bladder (OAB)
In brief
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.
Key facts
- Study ID
- NCT07300904
- Run by
- Stimuli Technology
- People needed
- 60
- Starts
- 2026-05-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai — Beverly Hills, California, United States
- NYU Langone Health — New York, New York, United States
- Toronto Western Hospital — Toronto, Canada
Full record on ClinicalTrials.gov
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