Urinary Stress Incontinence and Urgency in Women With EMSELLA

This is a blinded study to be conducted at San Diego Sexual Medicine in San Diego, CA.
Participants meeting inclusion and exclusion criteria will receive one treatment cycle of
active treatment or sham. The device will be equipped with 3 protocols in addition to the
standard protocol, two of which are identical to the standard protocol (for active treatment)
and one of which does not deliver HIFEM (for sham treatment). The active treatment arm
consists of 6 treatments, 2 per week, with at least one day in between. Follow-up visits will
occur at 4 weeks and 12 weeks after the last treatment. Unblinding will take place at the 12
week follow up visit, and subjects assigned to the sham arm will be crossed over to active
treatment, beginning their first treatment on that day, completing 6 treatments and 2 follow
up visits. Once unblinded the subject will be treated with the standard protocol of the
device.

After the informed consent is signed, and inclusion and exclusion criteria completed,
participants will complete validated questionnaires and undergo a baseline physical therapy
assessment of pelvic floor muscle strength.

Inclusion 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.

Exclusion Criteria:

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.