High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Sponsor

Boston Urogynecology Associates (Other)

Overall Status

Recruiting

CT.gov ID

NCT04031014

Collaborator

(none)

Enrollment

Location

Arms

40.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Urge Incontinence Urge and Stress Overactive Bladder	Device: BTL EMSELLA Active treatment Device: BTL EMSELLA Sham Treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Active and sham arms 1:1 run in parallelActive and sham arms 1:1 run in parallel

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Two blinded protocols are available on the device, neither investigators, participants or care providers will know the active treatment arm

Primary Purpose:

Treatment

Official Title:

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient global impression of improvement (PGI-I) [Baseline, 2 weeks after treatment, 3 months after treatment]
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.

Secondary Outcome Measures

24 hour voiding diary [Baseline, 2 weeks after treatment, 3 months after treatment]
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.
FSFI [Baseline, 2 weeks after treatment, 3 months after treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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