BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

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. Women and men ≥ 18 years of age

3. Self-reported bladder symptoms present ≥ 3 months

4. Self-reported failed conservative care of behavioral modifications and/or oralmedications

5. On a stable dose of antimuscarinics/beta-3 agonists for ≥ 4 weeks, and willing toremain on the medication for the duration of the study OR discontinuedantimuscarinics/beta-3 agonists for ≥ 2 weeks

6. Ambulatory and able to use a toilet independently, without difficulty

7. Subject agrees not to start any new treatment for OAB (medication or otherwise)during the treatment and follow-up periods. For Females Only:

8. 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))

Exclusion Criteria:

1. Botox® use in bladder or pelvic floor muscles in the past year

2. Subject weighs greater than 330 pounds

3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especiallyduring exercise; chest pain, such as squeezing, pressure of 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 thighs, at the discretion of the investigator.

5. Major metal implants such as: metal plates, screws, joint replacements, implantedcardiac pacemakers, drug pumps, neurostimulators, electronic implants, copperintrauterine devices, defibrillators, and metal implants in the pelvic area.Patients with other metal implants will be evaluated by the investigator forinclusion in the study.

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. Subject is currently receiving treatment for a malignant tumor that would interferewith study participation. Skin cancers are permitted.

11. Subject has used the BTL EMSELLA device previously

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

13. Current urinary tract infection. If a subject has a confirmed symptomatic UTI atscreening, per investigator's clinical judgment, they will be deferred fromscreening until treatment is completed, and may resume once symptoms have resolved

14. Current use of neuromodulation therapy, including interstim and PTNS, for bladdersymptoms within 3 months of screening visit (if past sacral/pudendal implant, mustbe explanted)

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

• 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.