NCT07300904

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.

Trial Health

67
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jan 2027

First Submitted

Initial submission to the registry

December 21, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

December 21, 2025

Last Update Submit

April 22, 2026

Conditions

Overactive Bladder (OAB)

Keywords

Overactive BladderTranscutaneous Tibial Nerve StimulationUrology

Outcome Measures

Primary Outcomes (1)

  • Treatment success

    Percentage of responders in urgency events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline to Week 12, in total urgency events per day, or returns to normal (0 events per day) at Week 12. This endpoint will be evaluated through 3-day bladder diaries.

    12 weeks

Secondary Outcomes (5)

  • Frequency of urinary voids

    12 weeks

  • Urge urinary incontinence

    12 weeks

  • Overall Responder Rate Across OAB Symptoms

    12 weeks

  • Quality of life measures

    12 weeks

  • Endurance of effect

    24 weeks

Study Arms (2)

Tensi+ device to be delivered for use by patient

ACTIVE COMPARATOR
Device: Tensi+

Identical Tensi+ Sham device to be delivered for use by patient

SHAM COMPARATOR
Device: Tensi+

Interventions

Tensi+DEVICE

Transcutaneous Tibial Nerve Stimulation

Identical Tensi+ Sham device to be delivered for use by patientTensi+ device to be delivered for use by patient

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars-Sinai

Beverly Hills, California, 90211, United States

Location

NYU Langone Health

New York, New York, 10017, United States

Location

Toronto Western Hospital

Toronto, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Akshaya Mariadassou

CONTACT

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

Sarah Todeschini

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2025

First Posted

December 24, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)CA(1)