Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

NCT ID: NCT04248491

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2023-07-13

Brief Summary

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of chronic pelvic pain. Currently there are no other studies utilizing the Emsella Chair for the treatment of chronic pelvic pain. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Detailed Description

Chronic pelvic pain (CPP) is a common and often debilitating in both men and women. It occurs below the umbilicus and is severe enough to cause functional impairment or require treatment. The health care burden of CPP is substantial. First line treatments involve a multidisciplinary approach and include general relaxation and stress management, patient education, self-care and behavioral modification, and pain management. Second-line agents include physical therapy (avoiding kegel exercises), and oral and intravesical agents. More invasive options including neuromodulation.

The Emsella chair is currently approved as a treatment for stress urinary incontinence. Chronic pelvic pain patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of stress urinary incontinence (SUI), in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Emsella Chair Active Treatment

Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the remainder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Group Type: ACTIVE_COMPARATOR

BTL Emsella chair

Intervention Type: DEVICE

Subjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Emsella Sham Treatment

Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (\<10% power).

Group Type: SHAM_COMPARATOR

BTL Emsella chair

Intervention Type: DEVICE

Subjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Interventions

BTL Emsella chair

Subjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about adverse events (AEs) and other clinically important information.

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

3. Self-reported CPP defined as pelvic pain that is non-cyclical and of at least 6 months duration and refractory to other treatments

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

5. Subject agrees to maintain a stable dose all current medications throughout the treatment and follow-up period

For Females Only:

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Kenneth M Peters, MD

Director and Chair of the Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital-Royal Oak

Locations

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-348

Identifier Type: -

Identifier Source: org_study_id