Overactive Bladder (OAB)NCT07300904
Tensi+ for Treating Overactive Bladder
A study testing Tensi+ in people with Overactive Bladder (OAB), run by Stimuli Technology at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Tensi+
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 May 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Cedars-Sinai
Beverly Hills, California, 90211
Karyn Eilber, 310-385-2992, Karyn.Eilber@cshs.org
Karyn Eilber
- Recruiting
NYU Langone Health
New York, New York, 10017
Benjamin Brucker, 646-825-6324, benjamin.brucker@nyulangone.org
Benjamin Brucker
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto
Dean Elterman, 416 603 5800 ext. ext. 5033, Dean.Elterman@uhn.ca
Dean Elterman
About this study
Official title: A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome
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)
- Being tested
- Tensi+
- Keywords
- Overactive Bladder, Transcutaneous Tibial Nerve Stimulation, Urology
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tensi+Device
Transcutaneous Tibial Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Tensi+ device to be delivered for use by patient | Active comparator | Not described Receives: Device: Tensi+ |
| Identical Tensi+ Sham device to be delivered for use by patient | Sham comparator | Not described Receives: Device: Tensi+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
Frequency of urinary voids
Percentage of responders in urinary frequency, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal
Measured: 12 weeks
Urge urinary incontinence
Percentage of responders in urge urinary incontinence, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal (0 events per day)
Measured: 12 weeks
Overall Responder Rate Across OAB Symptoms
Overall Responder rate defined as the percentage of responders who meet at least the responder criteria in one of the 3 symptoms of OAB, from baseline to Week 12 (urgency, frequency and UUI) from baseline
Measured: 12 weeks
Quality of life measures
Measured using the OAB-q Short Form (SF) questionnaire, which includes 19 questions scored from 1 ("none of the time") to 6 ("all of the time"). The total score ranges from 19 (best QOL) to 114 (worst QOL). A decrease in score from baseline to Week 12 indicates an improvement in quality of life.
Measured: 12 weeks
Endurance of effect
Maintenance of responder status from the primary endpoint (Week 12) through the last follow-up visit without relapse (Week 24), indicating a sustained treatment effect until the end-of-study visit.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start26 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stimuli Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300904
- Sponsor's protocol ID
- CIP-PF0001-02
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT07300904
- Acronym / sponsor ID
- CIP-PF0001-02
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Overactive Bladder, Transcutaneous Tibial Nerve Stimulation, Urology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stimuli TechnologyIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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+ |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tensi+Transcutaneous Tibial Nerve Stimulation | Device | Identical Tensi+ Sham device to be delivered for use by patient, Tensi+ device to be delivered for use by patient |
Primary outcome
Treatment success
Time frame: 12 weeks
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.
5 secondary outcomes
Frequency of urinary voids
Time frame: 12 weeks
Urge urinary incontinence
Time frame: 12 weeks
Overall Responder Rate Across OAB Symptoms
Time frame: 12 weeks
Quality of life measures
Time frame: 12 weeks
Endurance of effect
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder (OAB)
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Parasacral TENS Project
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RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
Overactive Bladder (OAB)
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PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Aquarius Pilot Study to Evaluate the New Axonics Trial System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tensi+ in people with Overactive Bladder (OAB), run by Stimuli Technology at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akshaya Mariadassou (+331 84 60 48 25, a.mariadassou@stimuli-technology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.