Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial

Stimuli Technology

Status

Begins enrollment this month

Conditions

Overactive Bladder (OAB)

Treatments

Device: Tensi+

Study type

Interventional

Funder types

Industry

Identifiers

NCT07300904

CIP-PF0001-02

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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-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