Overactive Bladder (OAB)
Conditions
Keywords
Overactive Bladder, Transcutaneous Tibial Nerve Stimulation, Urology
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.
Interventions
DEVICETensi+
Transcutaneous Tibial Nerve Stimulation
Sponsors
Stimuli Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of urinary voids | 12 weeks | 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 |
| Urge urinary incontinence | 12 weeks | 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) |
| Overall Responder Rate Across OAB Symptoms | 12 weeks | 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 |
| Quality of life measures | 12 weeks | 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. |
| Endurance of effect | 24 weeks | 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. |
Countries
Canada, United States
Contacts
CONTACTAkshaya Mariadassou
CONTACTSarah Todeschini
Outcome results
None listed