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โ† Trials
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Tensi+ for Treating Overactive Bladder

RecruitingNAAges 22 Years - anyAllStimuli Technology
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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-Barrรฉ 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
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What it tests

  • Tensi+
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Where

3 sites
Cedars-Sinai
Beverly Hills, United States
NYU Langone Health
New York, United States
Toronto Western Hospital
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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