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

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 3weeks prior to the implant and for the entire study period and not to changedosages/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 withability 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 ofcontraception 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, 5and 6 months after starting external device usage
16. Willing to complete a Patient Voiding Diary for 7 consecutive days prior to implantand 7 consecutive days before each follow-up visit, with moderate to severe urgecomponent at Baseline

Exclusion Criteria:

1. Neurogenic bladder
2. Urinary tract mechanical obstruction including but not limited to Benign ProstaticHyperplasia (BPH), treated or untreated, with ongoing significant obstruction
3. Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) orsurgery 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 stresscomponent 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 theimplant
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 ofbirth 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 involvingor 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, sacralnerve 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 toconfound study
17. Requirement for serial MRIs
18. Presence of a documented condition or abnormality that could compromise the safety ofthe patient
19. Life expectancy of less than 1 year