Clinical trial NCT04031014: High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
Official title: High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Urge Incontinence
Urge and Stress
Overactive Bladder
Keywords: Stress urinary incontinence, urge urinary incontinence, overactive bladder
Lead sponsor: Boston Urogynecology Associates
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active and sham arms 1:1 run in parallel
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
2. Age greater than 18
3. Subject has a body mass index (BMI) \< 37 kg/m2
4. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
5. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
6. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
7. Subject agrees to comply with the study procedures and visits.

Exclusion Criteria:

1. Subject has used the BTL EMSELLA device previously;
2. Subject has any significant pelvic organ prolapse; stage III or greater
3. Subject is unwilling to maintain current level of exercise throughout the study;
4. Subject planning to have surgery during the study;
5. Subject has untreated malignancy;
6. Subject is pregnant, planning to get pregnant or within 3 months postpartum;
7. Subject has a pacemaker;
8. Subject has and implant or IUD containing metal;
9. Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
10. Subject is using a pessary or other anti-incontinence device
11. Subject has implanted defibrillator, implanted neurostimulator
12. Subject has metal implants
13. Subject has a drug pump

Primary outcomes:
measure: Patient global impression of improvement (PGI-I)
timeFrame: Baseline, 2 weeks after treatment, 3 months after treatment
Secondary outcomes:
measure: 24 hour voiding diary
timeFrame: Baseline, 2 weeks after treatment, 3 months after treatment
measure: FSFI
timeFrame: Baseline, 2 weeks after treatment, 3 months after treatment
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Boston Urogynecology Associates
state: Massachusetts
Study officials:
References: