Recruiting
Not applicable
Tensi+ for Treating Overactive Bladder
Condition(s) studied
Overactive Bladder (OAB)
Investigational drug(s) / intervention(s)
Tensi+
Tensi+: Transcutaneous Tibial Nerve Stimulation
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Treatment success — 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.
Trial sites (3)
| Facility | City | Region | Status |
| Cedars-Sinai |
Beverly Hills |
California |
Recruiting |
| NYU Langone Health |
New York |
New York |
Recruiting |
| Toronto Western Hospital |
Toronto |
Canada |
Recruiting |
Other trials for the same condition