High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Description

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.

Conditions

Stress Urinary Incontinence, Urge Incontinence, Urge and Stress, Overactive Bladder

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Study Overview

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Study Details

Study overview

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.

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Condition
Stress Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Cambridge

Boston Urogynecology Associates, Cambridge, Massachusetts, United States, 02138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Urogynecology Associates,

Study Record Dates

2025-07