BTL Emsella for Stress Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial will test if the Emsella chair, which uses electromagnetic waves to strengthen pelvic muscles, is effective for people with stress urinary incontinence. The goal is to see if this treatment can reduce urine leakage during activities like exercise or laughing. This new technology is used for pelvic muscle strengthening for the treatment of stress urinary incontinence.
Will I have to stop taking my current medications?
You won't have to stop taking your current medications, but you must keep the dose stable if they affect urinary function. You also can't start any new treatments during the trial.
Is BTL Emsella safe for treating stress urinary incontinence?
How does the BTL Emsella treatment for stress urinary incontinence differ from other treatments?
BTL Emsella is unique because it uses High-Intensity Focused Electromagnetic (HIFEM) technology to stimulate pelvic floor muscles, which is a non-invasive approach compared to surgical options like slings or inlays. This treatment allows patients to remain fully clothed during sessions, making it more convenient and less invasive than traditional surgical methods.14678
What data supports the effectiveness of the treatment BTL Emsella for stress urinary incontinence?
Research suggests that extracorporeal magnetic stimulation (EMS), which is similar to the technology used in the BTL Emsella chair, is a non-invasive, effective, and safe treatment for stress urinary incontinence. This indicates that the BTL Emsella chair, which uses high-intensity focused electromagnetic (HIFEM) technology, may also be effective for this condition.145910
Who Is on the Research Team?
Kenneth M Peters, MD
Principal Investigator
Corewell Health William Beaumont University Hospital
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-80 with stress urinary incontinence, who can consent to the study's requirements. Participants must not start new treatments or change current medication doses during the study. Women using bladder support devices or of childbearing age must follow specific guidelines, while men should be post-prostatectomy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive electromagnetic perineal stimulation using the Emsella chair or sham treatment, with 8 sessions over 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of urinary incontinence and sexual function
What Are the Treatments Tested in This Trial?
Interventions
- BTL Emsella
- Sham BTL Emsella
BTL Emsella is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Beaumont Hospitals
Lead Sponsor