Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Females
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

Arm && Interventions

Group	Intervention	Description
TENS Treatment Arm	TENS	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.

Primary Outcome Measures

Name	Time	Method
Change in Urge Incontinence Episodes	Baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Micturitions Per Day	Baseline and 8 weeks	Mean number of urinary voids per day (taken over a 3-day period)
Change in Health-related Quality of Life (HRQL)	Baseline and 8 weeks	Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.