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

Inclusion Criteria

• 18 years of age or older
• Diagnosis of OAB and associated symptoms of UUI and qualify with at least 3 episodes of mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary
• Experiencing UUI symptoms for at least 3 months
• No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB
• Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol
• Willing and able to provide signed and dated informed consent

Exclusion Criteria

• 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)
• Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• Have implantable pacemakers or implantable defibrillators
• Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs
• Women who are pregnant or planning to become pregnant during the course of the study
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
• Nerve damage that could impact either tibial nerve or pelvic floor function.
• Subjects prone to excessive bleeding
• Inadequate skin integrity in the area of PTNM needle placement
• History of diabetes unless the diabetes is well-controlled through diet and/or medications
• Have symptomatic urinary tract infection (UTI)
• 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