Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

(EmsellaPain Trial)

Overseen By Jennifer Giordano, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Disqualifiers: Pulmonary insufficiency, Malignant tumor, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

11 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

No, you don't need to stop your current medications. You just need to keep taking them at the same dose throughout the trial.

How is the BTL Emsella Chair treatment different from other treatments for its condition?

The BTL Emsella Chair is unique because it uses high-intensity focused electromagnetic (HIFEM) technology to stimulate pelvic floor muscles, which is a non-invasive approach compared to traditional treatments that may involve surgery or medication. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on patients with chronic pelvic pain. These patients often have severe pain that doesn't respond well to usual treatments. The chair helps by making the pelvic muscles work out and get stronger. Electromagnetic fields (EMFs) provide a non-invasive, safe, and easy method to treat pain with respect to musculoskeletal diseases.

Research Team

Kenneth Peters, MD

Principal Investigator

Beaumont Hospital-Royal Oak

Eligibility Criteria

Inclusion Criteria

You have chronic pelvic pain that lasts for at least 6 months and doesn't go away with other treatments.

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 AEs and other clinically important information.

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

Exclusion Criteria

You weigh more than 330 pounds.

Current 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.

History of Hunner's lesion in the medical record

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Emsella Chair or Sham treatment twice a week for chronic pelvic pain

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• BTL Emsella Chair

Participant Groups

Group I: Emsella Chair Active Treatment Active Control 1 Intervention

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 II: Emsella Sham Treatment Placebo Group 1 Intervention

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).

BTL Emsella Chair is already approved in United States for the following indications:

Approved in United States as BTL Emsella Chair for:

• Urinary incontinence in women and men
• Sexual dysfunction including erectile dysfunction

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Superior outcome of pediatric acute myeloid leukemia patients with orbital and CNS myeloid sarcoma: a report from the Children's Oncology Group. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Extramedullary leukemia in children with newly diagnosed acute myeloid leukemia: a report from the Children's Cancer Group. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Spinal cord involvement as the presenting symptom of acute monocytic leukemia. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Extramedullary leukemia in children with acute myeloid leukemia: A population-based cohort study from the Nordic Society of Pediatric Hematology and Oncology (NOPHO). [2017]

5. Japan pubmed.ncbi.nlm.nih.gov

Myelosarcoma of the cavernous sinus in a nonleukemic patient--case report. [2019]