Urinary Stress Incontinence and Urgency in Women With EMSELLA

Eligibility Criteria

• 1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
• 2. Subject is female;
• 3. Subject is aged 21-80 years;
• 4. Subject has a body mass index (BMI) \< 37 kg/m2;
• 5. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
• 6. Subject is currently sexually active and willing to continue sexual activity throughout the study;
• 7. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
• 8. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
• 9. Subject agrees to comply with the study procedures and visits.
• 1. Subject has used the BTL EMSELLA device previously;
• 2. Subject has any significant pelvic organ prolapse;
• 3. Subject has clinically significant findings on physical examination;
• 4. Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
• 5. Subject is unwilling to maintain current level of exercise throughout the study;
• 6. Subject has been diagnosed with overactive bladder or interstitial cystitis;
• 7. Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
• 8. Subject experiences pain with sexual activity
• 9. Subject answers anything other than "almost never or never" or "a few times" on pain questions 17 or 18 of the Female Sexual Function Index (FSFI)
• 10. Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI)
• 11. Subject planning to have surgery during the study;
• 12. Subject has untreated malignancy;
• 13. Subject is pregnant, planning to get pregnant or within 3 months postpartum;
• 14. Subject has a pacemaker;
• 15. Subject has and implant or IUD containing metal (e.g. copper 7);
• 16. Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
• 17. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
• 18. Subject has received an investigational drug within 30 days prior to signing consent;
• 19. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.