Tensi+ for Treating Overactive Bladder
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Stimuli Technology
- Study ID
- NCT07300904
- Status
- Not Yet Recruiting
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Conditions
- Overactive Bladder (OAB)
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tensi+ — DEVICETranscutaneous Tibial Nerve Stimulation
Study Details
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.
Key Dates
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Tensi+ device to be delivered for use by patient
- Sham Comparator: Identical Tensi+ Sham device to be delivered for use by patient
Primary Outcome Measure
Treatment success [ Time Frame: 12 weeks ]
Central Contacts
- Akshaya Mariadassou+331 84 60 48 25
- Sarah Todeschini+331 84 60 48 25
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai | Beverly Hills | California | 90211 | Karyn Eilber (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Health | New York | New York | 10017 | Benjamin Brucker (PRINCIPAL_INVESTIGATOR) |
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