Recruiting

Tensi+ with TPTNS

Sponsor:

Stimuli Technology

Code:

NCT07300904

Conditions

Overactive Bladder (OAB)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Tensi+

Study Details

Brief 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.

Conditions

Overactive Bladder (OAB)

Study ID

NCT07300904

Start date

May 26, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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-BarrĂ© 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Tensi+

Transcutaneous Tibial Nerve Stimulation

Primary outcome measure

  • Treatment success [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Akshaya Mariadassou

+331 84 60 48 25a.mariadassou@stimuli-technology.com

Sarah Todeschini

+331 84 60 48 25s.todeschini@stimuli-technology.com

Locations

Cedars-Sinai

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Karyn Eilber

310-385-2992Karyn.Eilber@cshs.org

Principal Investigator:

Karyn Eilber

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Benjamin Brucker

646-825-6324benjamin.brucker@nyulangone.org

Principal Investigator:

Benjamin Brucker

Toronto Western Hospital

Recruiting

Toronto, Canada

Contacts

Dean Elterman

416 603 5800Dean.Elterman@uhn.ca

Principal Investigator:

Dean Elterman

More Information

Sponsor

Stimuli Technology

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Overactive Bladder
  • Transcutaneous Tibial Nerve Stimulation
  • Urology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Stimuli Technology on 2026-09-11.