Electromagnetic Therapy for Urinary Incontinence

Overseen By Kathy Rogers

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Boston Urogynecology Associates

Disqualifiers: Pelvic organ prolapse, Pregnancy, Pacemaker, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new treatment for urinary incontinence, which occurs when urine leaks accidentally. It uses high-intensity focused electromagnetic (HIFEM) technology to strengthen pelvic floor muscles, delivering the effect of 11,200 Kegel exercises in just 28 minutes. Participants will receive either the active treatment, known as BTL EMSELLA, or a sham (fake) treatment for comparison. The trial seeks individuals with stress or urge urinary incontinence who can maintain their current exercise routine during the study. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for urinary incontinence.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you maintain your current prescription and over-the-counter medications throughout the study without changing them.

What prior data suggests that this device is safe for treating urinary incontinence?

Research shows that the BTL EMSELLA treatment, which uses high-intensity focused electromagnetic (HIFEM) technology, is safe for people. Studies have found that this technology effectively treats urinary incontinence by strengthening pelvic muscles. No major negative effects have been reported, indicating that the treatment is generally well-tolerated. The treatment works by causing deep muscle contractions to improve strength and control. Previous studies found that patients usually handle the treatment well, without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BTL EMSELLA for urinary incontinence because it offers a non-invasive alternative to traditional treatments like pelvic floor exercises, medications, or surgery. This treatment uses electromagnetic therapy to stimulate pelvic floor muscles without the need for physical exertion or invasive procedures. Unlike medications that can have side effects, or surgeries that require recovery time, BTL EMSELLA sessions are quick, painless, and require no downtime, making it an appealing option for those seeking convenient and effective relief from urinary incontinence.

What evidence suggests that the BTL EMSELLA device is effective for urinary incontinence?

This trial will compare the effects of active and sham treatments using the BTL EMSELLA device for urinary incontinence. Research has shown that high-intensity focused electromagnetic (HIFEM) therapy, which participants in the active treatment arm will receive, can effectively treat urinary incontinence. In one study, patients experienced up to a 64% reduction in symptoms after completing the treatment. Another study found that HIFEM therapy increased urethral pressure, aiding urine flow control, particularly for those with stress incontinence. Patients also reported needing fewer pads, highlighting its practical benefits. Overall, these findings suggest that HIFEM technology can strengthen pelvic floor muscles and improve bladder control. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with urinary incontinence issues, specifically stress or urge incontinence. Participants must not change their medications during the study and should maintain their current level of core exercise. They can't join if they're pregnant, have metal implants including IUDs, pacemakers, drug pumps, or significant pelvic organ prolapse.

Inclusion Criteria

I agree to not change my current medications during the study.

I agree to not change my current medications during the study.

I have been diagnosed with a type of urinary incontinence.

Exclusion Criteria

You have a metal implant or IUD.

I have a cancer that has not been treated yet.

I am not willing to keep my current exercise routine during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the BTL EMSELLA device twice per week for six treatments total

3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL EMSELLA Active treatment
• BTL EMSELLA Sham Treatment

Trial Overview The trial tests a High Intensity Focused Electromagnetic (HIFEM) device called BTL EMSELLA that aims to strengthen pelvic floor muscles through intense contractions. It compares an active treatment against a sham (placebo) to see if it effectively treats urinary incontinence.

How Is the Trial Designed?

Group I: Active treatment Experimental Treatment 1 Intervention

Treatment with the active treatment protocol of the BTL EMSELLA device twice per week for six treatments total

Group II: Sham treatment Placebo Group 1 Intervention

Treatment with the sham protocol of the BTL EMSELLA device twice per week for six treatments total

BTL EMSELLA Active treatment is already approved in European Union, United States for the following indications:

Approved in European Union as BTL EMSELLA for:

• Urinary incontinence
• Stress urinary incontinence
• Urge urinary incontinence

Approved in United States as EMSELLA for:

• Urinary incontinence
• Stress urinary incontinence
• Urge urinary incontinence

Who Is Running the Clinical Trial?

Boston Urogynecology Associates

Lead Sponsor

Trials

10

Recruited

950+

Published Research Related to This Trial

Electromuscular stimulation (EMS) is a safe and effective treatment for pelvic floor muscle dysfunction in women, improving symptoms related to urinary and fecal incontinence, dyspareunia, vaginismus, and lax vaginal muscles.

Successful treatment with EMS requires proper patient selection and comprehensive training for healthcare providers, ensuring informed consent and thorough assessment of the patient's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromuscular stimulation for urinary incontinence: Levator 100. Dolman, M.[2005]

In a study of 33 patients, high-intensity focused electromagnetic (HIFEM) treatments significantly reduced subcutaneous fat thickness by an average of 19.0% after 1 month and 23.3% after 3 months, indicating its efficacy for fat reduction.

The treatment was well-tolerated with no reported discomfort, and 91% of participants expressed satisfaction with their results, highlighting the safety and acceptability of HIFEM as a noninvasive fat reduction option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Assessment of Subcutaneous Abdominal Fat Thickness After Treatments With a High-Intensity Focused Electromagnetic Field Device: A Multicenter Study. Katz, B., Bard, R., Goldfarb, R., et al.[2020]

Extracorporeal magnetic stimulation (EMS) was found to be a safe and effective treatment for stress urinary incontinence (SUI) and overactive bladder syndrome (OAB) in a study of 93 female patients over a 9-week period, with 94.1% of OAB patients and 86.8% of SUI patients reporting successful symptom relief.

While EMS significantly improved bothersome symptoms and quality of life, the objective cure rates were lower, at 61.7% for OAB and 42.1% for SUI, indicating that while EMS is beneficial, further research is needed to assess its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of extracorporeal magnetic energy stimulation on bothersome lower urinary tract symptoms and quality of life in female patients with stress urinary incontinence and overactive bladder. Lo, TS., Tseng, LH., Lin, YH., et al.[2013]

Flat Magnetic Stimulation (FMS) significantly improved urinary-related quality of life and increased urethral rhabdosphincter volume in women with stress urinary incontinence (SUI), outperforming pelvic floor muscle training (PFMT).

The study indicates that FMS is a safe and effective non-surgical treatment option for SUI, showing better objective and subjective cure rates compared to PFMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A Prospective Comparison Study. Frigerio, M., Barba, M., Cola, A., et al.[2023]

Magnet stimulation therapy, used for treating stress and urge incontinence, showed promising results, particularly in 27 patients, with 67% experiencing a significant reduction in urge incontinence symptoms after treatment.

This therapy is safe and non-invasive, making it a valuable alternative to traditional methods like electrostimulation, but it is not effective for patients with chronic pelvic pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnet stimulation therapy: a simple solution for the treatment of stress and urge incontinence?]. Kirschner-Hermanns, R., Jakse, G.[2018]

In a study of 25 patients with stress urinary incontinence, flat magnetic stimulation significantly improved objective measures of continence, which remained effective even at a 3-month follow-up.

However, subjective quality of life scores returned to baseline levels three months after treatment, suggesting that additional treatment cycles may be necessary to maintain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A 3-Month Follow-Up Study. Barba, M., Cola, A., Rezzan, G., et al.[2023]

In a study of 111 women with stress urinary incontinence, ExMI therapy (extracorporeal magnetic innervation) showed significant improvements, with 28% of participants becoming completely dry and 53% using no more than one pad per day after treatment.

The therapy was particularly effective for patients who used no more than 3 pads daily and had not undergone previous continence surgery, indicating that patient selection is crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence. Galloway, NT., El-Galley, RE., Sand, PK., et al.[2022]

High intensity focused electromagnetic field (HIFEM) devices have received FDA clearance for various dermatologic applications, including muscle stimulation and toning in areas like the abdomen, arms, and legs.

These technologies are designed to improve muscle tone and firmness, making them a promising option for non-invasive body contouring and muscle strengthening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Intensity Focused Electromagnetic Field (HIFEM) Devices in Dermatology“ Alexiades, M.[2020]

Citations

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

A Comparative Study on the Effects of High-Intensity ... Modest improvement of incontinence and laxity issues was seen in group II, probably attributed to the less recognizable improvement of PFM functioning.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12407011/

Evaluating the Efficacy of High-Intensity Focused ... HIFEM therapy significantly improved UI severity and reduced pad dependence in men with post-prostatectomy incontinence, with effects sustained ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04031014?cond=Electromagnetic%20field&aggFilters=status:not%20rec%20ava&rank=7

High Intensity Focused Electromagnetic Field Device for ... Magnetic stimulation has also been shown to improve urodynamic parameters, both increasing the maximum urethral pressure for patients with stress incontinence, ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lsm.23106

Safety and Efficacy of a Non‐Invasive High‐Intensity ... The average improvement of 49.93% in ICIQ-SF score was observed after the sixth treatment, which further increased to 64.42% at the follow-up ( ...

5. mdpi.com mdpi.com/2227-9059/12/12/2883

Effect of High-Intensity Focused Electromagnetic ... The urethral and vaginal topography were performed and found that HIFEM mainly worked on pelvic floor muscles (PFM) and enhanced their function and integrity.

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

Safety and Efficacy of a Non‐Invasive High‐Intensity ... This study demonstrated that HIFEM technology can safely and effectively treat stress, urge and mixed urinary incontinence by pelvic floor muscle strengthening.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03877640

Study Details | NCT03877640 | Urinary Stress Incontinence ... The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment ...

8. 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 ...

9. tandfonline.com tandfonline.com/doi/full/10.2147/TCRM.S478919

Full article: Is the High-Intensity Focused Electromagnetic ... HIFEM has demonstrated in our study its ability to safely and effectively treat female patients suffering from stress and mixed urinary incontinence.