Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Completed · Not applicable
Conditions studied: Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT03595215
- Run by
- Theranova, L.L.C.
- People needed
- 18
- Starts
- 2018-09-10
- Expected to finish
- 2019-09-17
- Last updated by the study team
- 2021-05-21
Who can join
Age: 55 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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