Evaluation of the The Neuromodulation System for the Treatment of Overactive Bladder Symptoms

Inclusion criteria

• Women and men aged between 18 and 80 years old (including 18 and 80 years old)；
• Individual with primary OAB, or with OAB symptoms, satisfies one of the following conditions:

① Urinary urgency: sudden and strong desire to urinate, and it is difficult to be subjectively suppressed and delayed urination ;

② Urge urinary incontinence: accompanied with urinary urgency or immediately after urinary urgency ;

③ Urination frequency: adults urination frequency ≥8 times during the daytime，≥2 times at night, and each urine volume <200 ml .

• Individual meets the diagnostic criteria of OAB: According to the OABSS questionnaire, urgency score ≥2 points, total score ≥3 points, and symptoms duration ≥3 months;
• Individual newly diagnosed with OAB have not been medicated, or is able to stop taking OAB-related drugs (M receptor block, β3 receptor agonists) for at least 2 weeks prior to enrollment;
• The subject has autonomy and can go to the toilet independently;
• Individual is ambulatory and able to use the toilet independently;
• Individual is capable and willing to participate in the study and provide the written informed consent.

Exclusion criteria

• Woman is pregnant or lactating, or woman of childbearing age who plans to become pregnant during the study period;
• Individual has Stress Urinary Incontinence (SUI);
• Individual has obvious urinary obstruction due to various reasons accompanied by residual urine volume> 100 ml;
• Individual has an implanted pacemaker, embedded cardioverter defibrillator, or other electrical medical devices (including sacral neuromodulation (SNM) devices)
• Individual has uncured urinary system infection;
• Individual has urinary calculus resulting in lower urinary tract symptoms;
• Individual has congenital urinary tract malformations causing uncured lower urinary tract symptoms;
• Individual has uncured cancers;
• Individual had undergone lower urinary tract surgery within 3 months;
• Individual has neurological diseases or injuries accompanied with uncured lower urinary tract symptoms;
• Individual has skin breakage, malignant tumor or acute purulent inflammation on the surface of the plantar where the electrode pads are to be placed;
• Individual has participated in other drug clinical trials medical dev within 3 months, or participated in other ice clinical trials within 30 days;
• Individual is deemed unsuitable for enrollment in the study by investigator.