Status:
COMPLETED
High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
Lead Sponsor:
Boston Urogynecology Associates
Conditions:
Stress Urinary Incontinence
Urge Incontinence
Eligibility:
FEMALE
18-100 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04031014
Start Date
February 1 2020
End Date
July 1 2025
Last Update
September 5 2025
Active Locations (1)
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1
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138