High Intensity Focused Electromagnetic Field Device for 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 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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Stress Urinary Incontinence; Urge Incontinence; Urge and Stress
• Intervention / Treatment: Device: BTL EMSELLA Active treatment; Device: BTL EMSELLA Sham Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathy Rogers; Phone Number: 617-354-5452; Email: krogers@mah.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Recruiting
      • Boston Urogynecology Associates
      • Contact: Kathy Rogers; Phone Number: 617-354-5452; Email: krogers@mah.harvard.edu
      • Principal Investigator: Peter Rosenbaltt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment; Treatment with the active treatment protocol of the BTL EMSELLA device twice per week for six treatments total	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
Sham Comparator: Sham treatment; Treatment with the sham protocol of the BTL EMSELLA device twice per week for six treatments total	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient global impression of improvement (PGI-I)	The PGI comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. The Patient Global Impression of Improvement (PGI-I) has been validated for use in female patients with urinary incontinence and prolapse. Using this measure we hope to assess for overall improvement in symptoms after treatment. Change from baseline will range from -6 to +6 with higher scores representing better outcomes.	Baseline, 2 weeks after treatment, 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour voiding diary	A three-day voiding diary is a validated measure based on the International Consultation on Incontinence Questionnaires and involves measurement of fluid intake, leakage episodes and pad useage. There is high correlation between a 24 hour voiding diary and a 3 day voiding diary with higher rates of compliance. Participants will therefore complete a 24 hour voiding diary prior to enrollment, at the conclusion of treatment and again at a 3 month follow up visit. In addition, patients will answer questions on the frequency of pad use. Using the voiding diary we will look specifically at leakage episodes, urgency episodes.	Baseline, 2 weeks after treatment, 3 months after treatment
FSFI	The FSFI was developed to measure female sexual function. The FSFI is a 19-item patient-reported outcome measure (PROM), consisting of 6 separate domains of female sexual function, namely desire (items 1-2), arousal (3-6), lubrication (7-10), orgasm (11-13), satisfaction (14-16), and pain (17-19). We will assess for change in total score of the FSFI from pre-treatment to follow up visits. Scores range from 2 to 36 with higher results representing better outcomes.	Baseline, 2 weeks after treatment, 3 months after treatment

Collaborators and Investigators

• Sponsor: Boston Urogynecology Associates

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Stress urinary incontinence, urge urinary incontinence, overactive bladder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: 021-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No