NCT04031014

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boston Urogynecology Associates · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will have looking at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.

Detailed description

Pelvic floor dysfunction is common and can include symptoms of urinary incontinence, fecal incontinence and prolapse. Studies suggest that pelvic floor dysfunction may affect up to 25% of women in the United States including 17.1% of women with moderate to severe urinary. While most causes of stress/stress predominant urinary incontinence and urge/urge predominant urinary incontinence are due to of poor pelvic floor musculature and abnormal neuromuscular control, the cause of these abnormalities is not known. Traumatic injuries to the pelvic area, such as in an accident, and complications from vaginal childbirth can contribute to this condition. Some cases are due to a learned behavior (repeated actions of straining). For most pelvic floor disorders, first line therapy involves behavioral modifications and pelvic floor physical therapy. Physical therapy has proven benefits for treatment of pelvic floor disorders and may improve symptoms in up to 70% of patients with any urinary incontinence (either OAB or SUI), and 60-70% patients with FI. Unfortunately, not all patients are able or willing to undergo treatment with pelvic floor physical therapy. During therapy, patients are undressed, and the therapist works internally palpating the muscles in the vagina and rectum to facilitate rehabilitation. Treatment with the BTL EMSELLA allows for similar rehabilitation of the pelvic floor while patients remain comfortably clothed. The use of magnetic stimulation to treat pelvic floor disorders has been studied previously. In one prospective cohort study of 91 women, treatment with weekly sessions of perineal magnetic stimulation was associated with improved quality of life and decreased urinary leakage episodes. Magnetic stimulation has also been shown to improve urodynamic parameters, both increasing the maximum urethral pressure for patients with stress incontinence, and increase bladder capacity for those with urgency incontinence. The BTL EMSELLA is a device cleared by the Food and Drug Administration (FDA) for entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence. High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will look at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.

Conditions

• Stress Urinary Incontinence
• Urge Incontinence
• Urge and Stress
• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	BTL EMSELLA Active treatment	BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 100% for active treatment
DEVICE	BTL EMSELLA Sham Treatment	BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 5% for sham treatment

Timeline

• Start date: 2020-02-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2019-07-24
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study