BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Inclusion Criteria:

1. Able to read, understand, and provide written, dated, informed consent prior toscreening, and be likely to comply with study protocol, including independentlycomplete study questionnaires and communicate with study personnel about AEs andother clinically important information.

2. Females and males, 18 to 80 years of age, inclusive, at screening

3. Positive Cough or Bladder Stress Test at screening

4. Subject agrees not to start any new treatment (medication or otherwise) during thetreatment and follow-up periods.

5. Subject agrees to maintain a stable dose of any medication known to affect lowerurinary tract function, including but not limited to anticholinergics, tricyclicantidepressants, beta-3 adrenergic agonist, or α-adrenergic blockers, throughout thetreatment and follow-up periods.

For Females Only:

• Subject agrees to discontinue use of bladder support devices, including but notlimited to vaginal pessary, during the screening, treatment, and follow-up periods.

• If of child-bearing age and female, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginalcontraceptive ring, IUD, implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))

For Males Only:

• Subject must be ≥ 4 months post radical prostatectomy

Exclusion Criteria:

1. Pelvic floor physical therapy, including muscle training and/or electrostimulation,in a clinical setting within 30 days prior to screening

2. Subject is morbidly obese (defined as body mass index 40 or greater)

3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especiallyduring exercise; chest pain, such as squeezing, pressure or tightness; the sensationof rapid or irregular heartbeat (palpitations); swelling of the legs or feet;dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)

4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks,and lower extremities

5. Implanted cardiac pacemaker or metal in the body, including, but not limited to drugpumps, neurostimulators, electronic implants, copper intrauterine devices (IUDs),and/or defibrillators

6. Subject has a piercing between the waist and knees and is not willing to remove itbefore each treatment

7. Active urethral diverticula

8. Known vesicoureteral reflux

9. Currently healing from surgical procedures where muscle contraction may disrupt thehealing process

10. Treatment with urethral bulking agents within the 6 months prior to the ScreeningVisit

11. Subject is currently receiving treatment for a malignant tumor that would interferewith study participation.

12. Subject has used the BTL EMSELLA device previously

13. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis,spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.

14. Clinically confirmed urinary tract infection, requiring treatment as determined bythe investigator, at the Screening Visit

15. Currently participating in an investigational study that may impact study results orpreviously received an investigational drug or treatment within 30 days of theScreening Visit

16. Current or history of any physical condition that, in the investigator's opinion,might put the subject at risk or interfere with study results interpretation For Females Only:

17. Pregnant, or planning to become pregnant, at screening or anytime throughout thestudy period

18. History of surgery with insertion of vaginal mesh for SUI

19. Vaginal prolapse beyond the introitus

20. Vaginal rejuvenation treatment, including laser treatments and radiofrequencytherapy, within the 6 months prior to the Screening Visit

• Note for the sake of preserving scientific integrity, one or more of theeligibility criteria have been left off the list posted while the trial isongoing. A full list of eligibility criteria will be posted upon completion ofthe trial.