Electromagnetic Therapy for Urinary Incontinence

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Urogynecology Associates

Disqualifiers: Pelvic organ prolapse, Pregnancy, Pacemaker, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special device that mimics doing thousands of Kegel exercises to help people with urinary incontinence. It targets those who have weak pelvic muscles and haven't had success with other treatments. The device strengthens these muscles using electromagnetic waves, which can improve bladder control.

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 data supports the effectiveness of this treatment for urinary incontinence?

Research shows that electromagnetic therapy, like the BTL EMSELLA, can help strengthen pelvic floor muscles and reduce symptoms of urinary incontinence. In one study, 28% of women were completely dry after treatment, and 53% used no or fewer pads, indicating improved bladder control. ^{1 2 3 4 5}

Is electromagnetic therapy safe for humans?

Electromagnetic therapy, including high-intensity focused electromagnetic (HIFEM) devices, is generally considered safe for humans when used correctly. It has been used for various conditions like muscle toning and urinary incontinence, with safety being a key consideration in its application. ^{2 5 6 7 8}

How is the BTL EMSELLA treatment for urinary incontinence different from other treatments?

BTL EMSELLA uses high-intensity focused electromagnetic (HIFEM) technology to stimulate pelvic floor muscles, which is unique because it allows patients to remain fully clothed during treatment sessions. This non-invasive approach contrasts with other treatments that may require surgery or direct muscle stimulation. ^{1 2 4 6 7}

Research Team

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• BTL EMSELLA Active treatment (Electromagnetic Field Device)
• BTL EMSELLA Sham Treatment (Electromagnetic Field Device)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Boston Urogynecology Associates

Lead Sponsor

Trials

10

Recruited

950+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Magnet stimulation therapy: a simple solution for the treatment of stress and urge incontinence?]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Australia 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. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A 3-Month Follow-Up Study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A Prospective Comparison Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

High Intensity Focused Electromagnetic Field (HIFEM) Devices in Dermatology“ [2020]

8. United States 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. [2020]