NCT03595215CompletedNot Applicable
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Theranova, L.L.C.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change in Urge Incontinence Episodes
Study Overview
Brief Summary
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •55-100 years old
- •Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
- •Have self-reported bladder symptoms of more than 3 months
- •Are ambulatory and able to use the toilet independently
- •Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
- •Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
- •Able to provide informed consent
- •Capable and willing to follow all study-related procedures
Exclusion Criteria
- •Have primary complaint of stress urinary incontinence
- •Have a pacemaker or implantable defibrillator
- •Had botox injections in the bladder or pelvic floor muscles in the past 12 months
- •Have a current urinary tract or vaginal infection
- •Have an active implantable SNS device (InterStim & Bion)
- •Have been diagnosed with peripheral neuropathy or nerve damage
- •Currently pregnant
- •Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Arms & Interventions
TENS Treatment Arm
Experimental
This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.
Intervention: TENS (Device)
Outcomes
Primary Outcomes
Change in Urge Incontinence Episodes
Time Frame: Baseline and 8 weeks
Secondary Outcomes
- Change in Micturitions Per Day(Baseline and 8 weeks)
- Change in Health-related Quality of Life (HRQL)(Baseline and 8 weeks)
Investigators
Study Sites (1)
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