Tensi+ device for overactive bladder using Transcutaneous Tibial Nerve Stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests the Tensi+ device, which delivers Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) to adults with overactive bladder. The goal is to determine safety and whether the device can lessen urinary urgency, frequency, and urge incontinence. Eligible participants have had OAB symptoms for at least three months and meet diary-based thresholds for urgency and voids per day. Exclusion criteria include implanted electronic devices, bleeding risks, nerve conditions affecting the pelvic region, pregnancy, and certain ankle or skin issues. The study is led by Stimuli Technology with sites in California, New York, and Toronto.

Why it matters

Who can join: the full rules

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 it's running

• Cedars-Sinai
  Beverly Hills, California, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting
• Toronto Western Hospital
  Toronto, Canada Recruiting

Study contacts

• Study coordinator: Akshaya Mariadassou
• Email: a.mariadassou@stimuli-technology.com
• Phone: +331 84 60 48 25

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.