Tensi+ for Treating Overactive Bladder (NCT07300904) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tensi+ for Treating Overactive Bladder
United States, Canada60 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-Barr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.