Tensi+ for Treating Overactive Bladder
ConditionOveractive Bladder (OAB)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorStimuli Technology
About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tensi+
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov