NCT07300904 · Stimuli Technology
Tensi+ for Treating Overactive Bladder
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Tensi+
Transcutaneous Tibial Nerve Stimulation
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Beverly Hills, California
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations