Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial
NCT ID: NCT07300904
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2026-03-31
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tensi+ device to be delivered for use by patient
Tensi+
Transcutaneous Tibial Nerve Stimulation
Identical Tensi+ Sham device to be delivered for use by patient
Tensi+
Transcutaneous Tibial Nerve Stimulation
Interventions
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Tensi+
Transcutaneous Tibial Nerve Stimulation
Eligibility Criteria
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Inclusion Criteria
* 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 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
22 Years
ALL
No
Sponsors
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Stimuli Technology
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai
Beverly Hills, California, United States
NYU Langone Health
New York, New York, United States
Toronto Western Hospital
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP-PF0001-02
Identifier Type: -
Identifier Source: org_study_id
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