Emsella Chair for Pelvic Pain

(EmsellaPain Trial)

Overseen By Jennifer Giordano, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corewell Health East

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the BTL Emsella Chair, which uses electromagnetic technology, can reduce chronic pelvic pain. Participants will compare this therapy to a sham treatment that mimics the experience without the active technology. It is ideal for individuals who have experienced non-cyclical pelvic pain for over six months and have not found relief with other treatments. Participants will receive two treatments per week for four weeks. As an unphased trial, this study provides a unique opportunity for patients to explore a novel treatment option for chronic pelvic pain.

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.

What prior data suggests that the Emsella Chair therapy is safe for treating chronic pelvic pain?

Research has shown that the BTL Emsella Chair, which uses electromagnetic technology, is generally easy to tolerate. This chair primarily treats urinary incontinence, or loss of bladder control, and has been studied for safety in this context. One study found the Emsella Chair to be safe and effective, with no serious side effects reported. During treatment, users might feel slight muscle contractions, which is normal and not harmful.

Since this trial tests a device similar to those already approved for other conditions, the risks are low. The treatment is non-invasive, meaning it doesn't involve surgery or breaking the skin, which typically results in fewer risks and side effects. For those considering joining this trial, available evidence suggests that the Emsella Chair is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for chronic pelvic pain, which often include medications or invasive procedures, the Emsella Chair offers a non-invasive approach using High-Intensity Focused Electromagnetic (HIFEM) technology. This innovative method stimulates pelvic floor muscles, helping to strengthen and rehabilitate them without surgery or downtime. Researchers are excited about this treatment because it promises an effective and comfortable alternative, potentially providing relief with minimal side effects and without the need for daily medication.

What evidence suggests that the Emsella Chair is effective for chronic pelvic pain?

Research has shown that the Emsella Chair, which uses high-intensity focused electromagnetic (HIFEM) technology, effectively strengthens pelvic floor muscles. In this trial, participants will receive either the Emsella Chair Active Treatment or the Emsella Sham Treatment. Studies have found this method more effective than traditional treatments for weak pelvic floors. While specific studies on its use for chronic pelvic pain are lacking, the chair has demonstrated positive results for similar issues, such as stress urinary incontinence. The technology induces strong, deep contractions in the pelvic muscles, enhancing their strength and function. This suggests that the Emsella Chair might help reduce chronic pelvic pain by stabilizing the pelvic floor. ^{4 5 6 7 8}

Who Is on the Research Team?

Kenneth Peters, MD

Principal Investigator

Beaumont Hospital-Royal Oak

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BTL Emsella Chair

How Is the Trial Designed?

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?

Corewell Health East

Lead Sponsor

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8016513/

A Comparative Study on the Effects of High-Intensity ...

According to the documented results, we suggest that HIFEM therapy was more effective method for treatment of weakened pelvic floor than electrostimulation in ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/91/NCT04248491/Prot_SAP_000.pdf

A Single-Blind, Randomized Study of the BTL Emsella™ ...

The subject will experience tingling and pelvic floor muscles' contractions during the treatment. The subject may resume daily activities immediately after the ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12026803/

Prospective Comparative Study of EMSella Therapy and ...

The results indicate that anterior colporrhaphy is significantly more effective in reducing prolapse and improving bladder function.

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04133675/btl-emsella-chair-versus-sham-for-the-treatment-of-stress-urinary-incontinence

BTL Emsella Chair Versus Sham for the Treatment of ...

This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

5.

btlaesthetics.com

btlaesthetics.com/en/for-providers/emsella-providers

EMSELLA - A breakthrough treatment for incontinence and ...

EMSELLA uses HIFEM energy to cause deep and intense pelvic-floor muscle contractions, helping your incontinent patients regain their confidence. HIFEM ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6851770/

Safety and Efficacy of a Non‐Invasive High‐Intensity ...

The aim of this study was to objectively evaluate the efficacy and safety of the BTL EMSELLA device (BTL Industries Inc., Boston, MA) utilizing ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf18/K181497.pdf

November 14, 2018 BTL Industries, Inc. David Chmel VP of ...

Applicator Chair is designed for non-invasive therapy of urinal incontinence. The coil is located in the middle of the seat and air cooled.

8.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04873037

BTL Emsella Chair Versus Sham for the Treatment of ...

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 ...