Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

Exclusion Criteria

• •1. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening.
• •2. Pelvic floor trigger point injections, pudendal nerve block, or bladder hydrodistention within 30 days prior to screening
• •3. Subject weighs more than 330 pounds
• •4. Current urinary tract infection (UTI). If a subject has a confirmed symptomatic UTI at screening, per the investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved.
• •5. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
• •6. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
• •7. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
• •8. History of Hunner's lesion in the medical record
• •9. Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study.
• •10. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
• •11. Subject has used the BTL EMSELLA device previously
• •12. Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
• •13. 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:
• •14. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
• •Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.