Health TrialsbyHealthPanel

Tensi+ for Treating Overactive Bladder

ConditionOveractive Bladder (OAB)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tensi+

    Device

    Transcutaneous Tibial Nerve Stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tensi+ device to be delivered for use by patientActive comparator 1 intervention
Group B: Identical Tensi+ Sham device to be delivered for use by patientSham comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

Time frame
12 weeks
2

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)

Time frame
12 weeks
3

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

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stimuli Technology

Lead sponsor

Source ClinicalTrials.gov
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