PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB

Exclusion Criteria

• •1. Have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB or advanced therapy treatment options for OAB (botulinum toxin injections, sacral neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation)
• •2. Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• •3. Have implantable pacemakers or implantable defibrillators
• •4. Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs
• •5. Women who are pregnant or planning to become pregnant during the course of the study
• •6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
• •7. Nerve damage that could impact either tibial nerve or pelvic floor function.
• •8. Subjects prone to excessive bleeding
• •9. Inadequate skin integrity in the area of PTNM needle placement
• •10. History of diabetes unless the diabetes is well-controlled through diet and/or medications
• •11. Have symptomatic urinary tract infection (UTI)
• •12. Participation in any research study involving or impacting gynecologic, urinary or renal function within the 4-week period prior to or plans to participate during study enrollment