What side effects are associated with this type of intervention?

Common treatments for stress urinary incontinence (SUI) include pelvic floor muscle training (Kegel exercises), medications, and surgical interventions such as sling procedures. Side effects of these treatments can vary. Pelvic floor exercises generally have minimal side effects but may cause temporary muscle soreness. Medications can lead to dry mouth, constipation, and blurred vision. Surgical options may result in complications like urinary tract infections, pain, and mesh erosion. Treatments similar to the Emsella chair, which uses electromagnetic technology to stimulate pelvic floor muscles, are generally well-tolerated but can cause temporary discomfort, muscle spasms, or tingling sensations during the procedure.

What prior FDA approvals exist?

The Emsella chair, which uses electromagnetic technology to treat stress urinary incontinence (SUI), represents a novel approach. Traditional FDA-approved treatments for SUI include pelvic floor muscle training, medications like duloxetine, and surgical options such as sling procedures. While the Emsella chair itself may not yet be FDA-approved, it is part of ongoing research to determine its efficacy compared to sham treatments. Electromagnetic technology for SUI is still under investigation, and more data is needed to establish its place among FDA-approved therapies.

What other types of research exist?

Promising novel alternatives to the Emsella chair for treating stress urinary incontinence in 2024 include: 1) Pelvic floor muscle training (PFMT) with biofeedback, which uses sensors to provide real-time feedback to patients during exercises. 2) Laser therapy, which has shown efficacy in improving pelvic floor muscle strength and reducing SUI symptoms. 3) Radiofrequency therapy, which uses energy waves to stimulate collagen production and improve tissue support around the urethra. 4) Magnetic stimulation devices, similar to the Emsella chair but with different configurations or enhanced features for targeted therapy.

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Electromagnetic Technology

BTL Emsella for Stress Urinary Incontinence

Q: What is the mechanism of action of this treatment?

Stress Urinary Incontinence (SUI) is commonly treated through pelvic floor muscle training (PFMT), surgical interventions, and more recently, electromagnetic technology like the Emsella chair. PFMT strengthens the pelvic floor muscles, which support the bladder and urethra, reducing urine leakage during activities that increase intra-abdominal pressure. Surgical options, such as sling procedures, provide structural support to the urethra. The Emsella chair uses high-intensity focused electromagnetic (HIFEM) technology to stimulate deep pelvic floor muscles, enhancing their strength and endurance without the need for active patient participation. Understanding these mechanisms is crucial for SUI patients as it helps them make informed decisions about their treatment options, considering factors like invasiveness, required effort, and potential effectiveness.

N/A

Recruiting

Led By Kenneth Peters, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Females Only: Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods.

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

Must not have

For Females Only: Pregnant, or planning to become pregnant, at screening or anytime throughout the study period

Subject is morbidly obese (defined as body mass index 40 or greater)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after primary efficacy endpoint

Summary

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.

Who is the study for?

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.

What is being tested?

The trial tests the Emsella chair against a sham (fake treatment) to see if electromagnetic technology helps treat involuntary urine leakage caused by pressure from activities like coughing or laughing.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort due to sitting on the chair, skin sensation changes where electromagnetic waves pass, and possible muscle contractions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to not use any bladder support devices during the study.

Select...

I agree not to start new treatments during the study period.

Select...

I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant and do not plan to become pregnant during the study.

Select...

My BMI is 40 or higher.

Select...

I have a piercing between my waist and knees and won't remove it for treatment.

Select...

I am not currently receiving treatment for another cancer that would affect my participation.

Select...

I experience breathing difficulties, chest pain, and other related symptoms.

Select...

I have a confirmed urinary tract infection that needs treatment.

Select...

I cannot feel my pelvis, buttocks, or legs normally.

Select...

I have had surgery to insert vaginal mesh for stress urinary incontinence.

Select...

I have been diagnosed with vesicoureteral reflux.

Select...

I have undergone pelvic floor physical therapy in the last 30 days.

Select...

I have an active urethral diverticulum.

Select...

I have bladder control issues due to a condition like MS, Parkinson's, or spinal injury.

Select...

I have a vaginal prolapse that extends outside the opening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after completing all treatments

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after completing all treatments

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after completing all treatments for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary Stress Incontinence

Secondary study objectives

Durability to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group

Safety objective to determine the safety and tolerability of Emsella Chair compared to sham

The efficacy of the Emsella chair versus sham to treat SUI in relation to the change in subject-reported impression of SUI severity.

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Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Emsella Chair Active TreatmentActive Control1 Intervention

Active treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. 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 then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Group II: Emsella Sham TreatmentPlacebo Group1 Intervention

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stress Urinary Incontinence (SUI) is commonly treated through pelvic floor muscle training (PFMT), surgical interventions, and more recently, electromagnetic technology like the Emsella chair. PFMT strengthens the pelvic floor muscles, which support the bladder and urethra, reducing urine leakage during activities that increase intra-abdominal pressure. Surgical options, such as sling procedures, provide structural support to the urethra. The Emsella chair uses high-intensity focused electromagnetic (HIFEM) technology to stimulate deep pelvic floor muscles, enhancing their strength and endurance without the need for active patient participation. Understanding these mechanisms is crucial for SUI patients as it helps them make informed decisions about their treatment options, considering factors like invasiveness, required effort, and potential effectiveness.