A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder

Inclusion Criteria:

1. Male or female and 18 years of age or older at the time of enrollment

2. Willing and capable of giving informed consent

3. Willing and able to comply with all Study-related requirements and procedures

4. Have been diagnosed or have symptoms of OAB for at least 3 months prior toenrollment

5. Have an average of 11 or more voiding events and/or 3 or more incontinent events per 24-hour period in a 3-Day Bladder Diary(a minimum of 30 voiding events over the 3days measured by the Diary)

6. If currently on medications that may affect their OAB symptoms, is on a stable dose (no new, discontinued, or change in dose) of all prescribed medications for at least 4 weeks prior to enrollment or throughout the Study

7. Female Subjects of child-bearing potential must have a negative urine dip stickpregnancy test at baseline

Exclusion Criteria:

1. Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors,Parkinson's etc.)

2. Have failed a third line treatment (PTNS, Botox or SNS) for their OAB because oflack of effectiveness within the 2 years prior to enrollment

3. Have evidence of an uncontrolled active disruptive psychological or psychiatricdisorder or other known condition significant enough to impact perception of pain,compliance of intervention and/or ability to evaluate treatment outcomes, in theopinion of the Investigator

4. Has or had a significant untreated substance use disorder or polysubstance usedisorder stemming from dependency-producing medications, alcohol, and/or illicitdrugs less than 6 months prior to enrollment

5. Are planning to or have scheduled a surgery, for any condition, that would requirecatheterization, or a prolonged hospital stay and affect the ability to ambulate,use the toilet, or complete Therapy during the first 12 weeks of the Study

6. Has symptoms of, been diagnosed, or being actively treated for benign prostatichyperplasia or prostate cancer (weak stream, straining, hesitancy, or intermittency)

7. Have a pacemaker or implanted defibrillator

8. Has a neurological disorder that affects the bladder or a diagnosis of interstitialcystitis, radiation cystitis, or fistulas

9. Incontinence due to stress-predominant mixed urinary incontinence (greater that 60%of the time)or being actively treated for stress urinary incontinence(Diagnosed orby review of the Baseline 3-Day Bladder Diary)

10. Has been diagnosed with or has symptoms of polyuria (>2500 cc urine output per day)

11. Has urinary retention or incomplete bladder emptying

12. Have a documented current or reoccurring Urinary Tract Infection (3 or more in themonths prior to enrollment)

13. Have had Botox treatment for their OAB in the previous 8 months

14. Have used TENS anywhere on the body within the last year for any reason oranticipated use of TENS within 12 weeks of enrollment in pelvic region, back or legsfor any reason

15. Had PTNS treatment for OAB within 6 months prior to enrollment.

16. Use of investigational drug/device Therapy, for any reason, within past 12 weeks

17. Current use or implantation of an implanted device for treatment of their OAB orincontinence (including but not limited to sacral nerve stimulators)

18. Participation in another clinical Study during the term of the Study

19. Pregnant or planning to become pregnant during the Study. Female Subjects ofchildbearing potential who become pregnant during the Study will be withdrawn fromthe Study and will be asked to sign a separate pregnancy consent form to allow theInvestigator and Sponsor to follow up on the Subject's pregnancy and outcome

20. Has scar tissue, metal, or another implant or a large tattoo that might interferewith Therapy

21. Has a neurological disorder that causes abnormal sensations in the lower leg (lossof sensation or allodynia)

22. Has a skin condition, for example allergic reaction, rash or open wounds, in thearea of where the Therapy Garment will be placed