What side effects are associated with this type of intervention?

Common treatments for stress incontinence that focus on strengthening pelvic floor muscles include pelvic floor muscle training (Kegel exercises), electrical stimulation, and magnetic stimulation. The known side effects of these treatments are generally mild and may include temporary discomfort, muscle fatigue, and slight pain during or after the procedure. Specifically, for HIFEM technology, which induces deep pelvic floor muscle contractions, side effects may include muscle soreness, mild pain, and temporary muscle spasms. Serious adverse events are rare.

What prior FDA approvals exist?

The FDA has approved several treatments for stress incontinence that focus on improving pelvic floor muscle strength and neuromuscular function. One such treatment is the use of pelvic floor muscle training (PFMT), commonly known as Kegel exercises, which has been a standard non-invasive approach. Additionally, electrical stimulation devices that target pelvic floor muscles have also received FDA approval. These devices work by sending mild electrical pulses to the pelvic floor muscles, causing them to contract and strengthen over time. While HIFEM technology is a newer approach that induces deep pelvic floor muscle contractions, it aligns with the principle of enhancing neuromuscular tone to treat stress incontinence.

What other types of research exist?

Promising novel alternatives to HIFEM technology for stress incontinence include: 1) Magnetic Resonance-guided Focused Ultrasound (MRgFUS) which uses high-intensity ultrasound waves to target and treat tissues, 2) Radiofrequency Ablation (RFA) which uses heat generated by radio waves to shrink and tighten tissues, and 3) Intravesical Botulinum Toxin-A injections which reduce bladder muscle overactivity. These treatments have shown potential in improving symptoms of stress incontinence and are being explored for their efficacy and safety.

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Electromagnetic Field Device

Electromagnetic Therapy for Urinary Incontinence

N/A

Recruiting

Research Sponsored by Boston Urogynecology Associates

Eligibility Criteria Checklist

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

Must have

Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;

Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID

Must not have

Subject has untreated malignancy

Subject planning to have surgery during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks after treatment, 3 months after treatment

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include discomfort from the electromagnetic field's effect on pelvic muscles and possible skin irritation where the device is used.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a type of urinary incontinence.

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I have been diagnosed with a type of urinary incontinence.

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I am older than 18 years.

Exclusion Criteria

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

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I have a cancer that has not been treated yet.

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I plan to undergo surgery during the study period.

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I have a severe pelvic organ prolapse.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks after treatment, 3 months after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks after treatment, 3 months after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks after treatment, 3 months after treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patient global impression of improvement (PGI-I)

Secondary study objectives

24 hour voiding diary

FSFI

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatmentExperimental Treatment1 Intervention

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

Group II: Sham treatmentPlacebo Group1 Intervention

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

0 / 7Eligibility 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 incontinence treatments often focus on strengthening the pelvic floor muscles, which support the bladder and urethra. Pelvic floor muscle training (Kegel exercises) and High Intensity Focused Electromagnetic (HIFEM) technology are common approaches. HIFEM technology induces deep pelvic floor muscle contractions, simulating thousands of Kegel exercises in a short time, thereby enhancing neuromuscular tone. This improved muscle strength provides better support for the bladder and urethra, reducing urine leakage during activities that increase abdominal pressure. Understanding these mechanisms helps patients appreciate the importance of muscle strength in managing stress incontinence and the potential benefits of advanced therapies like HIFEM.