Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial

Approximately 180 subjects will be enrolled in the Percutaneous Tibial Nerve Stimulation
(PTNS) for Overactive Bladder study. After signing the informed consent and completing the
screening visit, eligible candidates will be asked to (1) stop any OAB medications (including
but not limited to anti-muscarinic medication or tricyclic antidepressants (TCA) as well as
stabilize dosage and frequency of any concomitant medications for 3 weeks, if applicable, and
then (2) complete a daily Patient Voiding Diary for 7 days .

Subjects will then return to the office for baseline review. If all screening and baseline
criteria are met, the subject will be enrolled, randomized in a 1:1 ratio into either the
"control group" or the "investigational group" and scheduled for implant with the StimRouter
device.

After approximately 3 weeks for healing post-implant, study participants will be programmed
according to their randomization assignment. All subjects will be instructed to apply
stimulation at least 3 days/week for at least 30 minutes/day (i.e., the minimum protocol
requirements for device use) for 6 months and to apply stimulation when they anticipate OAB
events. Patient Voiding Diaries will be completed by the participants for 7 days prior to
each follow-up visit and provided to the office at each follow-up visit. Follow-up visits
will occur at Month 1, Month 2, Month 3, Month 5 and Month 6. Each follow-up visit will
include the review of subject voiding diaries and the completion of other subject
questionnaires for measuring OAB and quality of life assessments. Final follow-up evaluations
for all subjects will occur at Month 6.

Inclusion Criteria:

1. Male or female age ≥22 years and competent to provide consent

2. Minimum 3 months of self-reported OAB symptoms

3. A mean score of ≥4.0 on the OAB-q symptom questions 1-8

4. Diagnosis of OAB with Overactive Bladder Symptom Score (OABSS) ≥ 8.0

5. Average urinary frequency of ≥ 10 daily voids associated with urgency

6. Able to tolerate and sense tibial nerve stimulation

7. Willing to discontinue OAB and/or tricyclic antidepressant (TCA) medications for 3
weeks prior to the implant and for the entire study period and not to change
dosages/frequency of all others for 3 weeks prior to the implant

8. Failed/inadequate response to first- and second-line therapy for OAB

9. Body mass index (BMI) < 31 or investigator does not expect BMI to interfere with
ability to place the implant or negatively impact healing at implant site

10. Able to toilet self and have and maintain good personal hygiene

11. Able to utilize the StimRouter system independently

12. Negative urine dipstick result (no UTI detected)

13. If female of child-bearing age, willing to use a medically-acceptable method of
contraception for the duration of the study (e.g. oral contraceptives, condoms, shot,
patch, etc.)

14. Able to provide clear, thoughtful responses to questions and questionnaires

15. Willing to visit office for device programming and clinical evaluations at 1, 2, 3, 5
and 6 months after starting external device usage

16. Willing to complete a Patient Voiding Diary for 7 consecutive days prior to implant
and 7 consecutive days before each follow-up visit, with moderate to severe urge
component at Baseline

Exclusion Criteria:

1. Neurogenic bladder

2. Urinary tract mechanical obstruction including but not limited to Benign Prostatic
Hyperplasia (BPH), treated or untreated, with ongoing significant obstruction

3. Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or
surgery in past 12 months

4. Urinary tract, bladder or vaginal infection or inflammation

5. More than minimal level of stress incontinence or mixed incontinence with stress
component likely to confound study outcome

6. Type I diabetes or uncontrolled Type II diabetes

7. Allergy to local anesthetic or adhesives

8. Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the
implant

9. Pregnant, lactating, planning to become pregnant, given birth in the past 12 months,
or female of child-bearing potential and not practicing a medically-approved method of
birth control

10. Skin lesions or compromised skin at the implant or stimulation site

11. Use of investigational drug or device therapy or participation in any study involving
or impacting gynecologic, urinary or renal function within past 4 weeks

12. Implanted neurostimulator, pacemaker, or defibrillator

13. Current use of TENS in pelvic region, back or leg

14. Current or prior use of electrical stimulation therapy for OAB (e.g. PTNS, sacral
nerve stimulation, pelvic floor muscle stimulation or biofeedback)

15. Metallic implant below knee, within 6 inches of proposed site for implanted lead

16. Prior vaginal mesh or similar surgery that has not abolished stress incontinence,
intravaginal pessaries, or other evidence of stress incontinence significant enough to
confound study

17. Requirement for serial MRIs

18. Presence of a documented condition or abnormality that could compromise the safety of
the patient

19. Life expectancy of less than 1 year