Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9%
in the United States and has been found to increase with age. OAB has a negative impact on
health related quality of life (QoL), Per American Urological Association (AUA) / Society of
Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is
a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral
neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported
that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global
response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also
had statistically significant improvements in frequency, nighttime voids, voids with moderate
to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is
also early data from an implanted chronic tibial nerve stimulation lead study that shows a
minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in
incontinence episodes per day at one week. Our study will test the concept of whether the
PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of
each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical
improvement after a one week induction course.

Inclusion Criteria:

- Women and men > 18 years of age

- Self-reported failed conservative care of behavioral modifications and / or oral
medications

- A score the OAB-q symptom bother short form completed by the patient at screening
indicating quite a bit of bothersome urinary symptoms

- An above normal urinary frequency as recorded on initial 3-day voiding diary

- Self-reported bladder symptoms > 3 months

- Discontinued antimuscarinics/beta-3 agonists for > 2 weeks

- Capable of giving informed consent

- Ambulatory and able to use toilet independently without difficulty

- Capable and willing to follow all study-related procedures

Exclusion Criteria:

- Pregnant or planning to become pregnant during study duration

- Diagnosis of neurogenic bladder

- Botox use in bladder or pelvic floor muscles within past 12 months

- Pacemakers or implantable defibrillators

- Current urinary tract infection

- Active use of neuromodulation in any other form. If patient has InterStim, must be
turned off for 2 weeks for a washout period and remain off during the entirety of the
study.

- Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region,
back or legs

- Previous PTNS treatment who received greater than 6 treatments. Those who have
received less than 6 treatments will be allowed to screen if the last treatment was at
least 6 months prior to screening.

- Use of investigational drug/device therapy within past 4 weeks

- Participation in any clinical investigation involving or impacting gynecologic,
urinary or renal function within past 4 weeks

- Current or past history of any physical condition that, in the investigator's opinion,
might put the subject at risk or interfere with study results interpretation (i.e.
pelvic cancer or pelvic radiation treatment)