Emsella Chair for Pelvic Pain
(EmsellaPain Trial)
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.12345Why 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.45678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Emsella Chair or Sham treatment twice a week for chronic pelvic pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BTL Emsella Chair
BTL Emsella Chair is already approved in United States for the following indications:
- Urinary incontinence in women and men
- Sexual dysfunction including erectile dysfunction
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Beaumont Hospitals
Lead Sponsor