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High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031014
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Peter L. Rosenblatt, MD, Boston Urogynecology Associates

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Patient global impression of improvement (PGI-I) [ Time Frame: 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 :
  1. 24 hour voiding diary [ Time Frame: 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.

  2. FSFI [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031014


Contacts
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Contact: Kathy Rogers 617-354-5452 krogers@mah.harvard.edu

Locations
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United States, Massachusetts
Boston Urogynecology Associates Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathy Rogers    617-354-5452    krogers@mah.harvard.edu   
Principal Investigator: Peter Rosenbaltt, MD         
Sponsors and Collaborators
Boston Urogynecology Associates

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Responsible Party: Peter L. Rosenblatt, MD, Division Director, Boston Urogynecology Associates
ClinicalTrials.gov Identifier: NCT04031014    
Other Study ID Numbers: 021-2019
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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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
Keywords provided by Peter L. Rosenblatt, MD, Boston Urogynecology Associates:
Stress urinary incontinence, urge urinary incontinence, overactive bladder
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases