High Intensity Focused Electromagnetic Field Device for Urinary Incontinence (NCT04031014) | Clinical Trial Compass
CompletedNot Applicable
High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
United States36 participantsStarted 2020-02-01
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
What they're measuring
1
Patient global impression of improvement (PGI-I)
Timeframe: Baseline, 2 weeks after treatment, 3 months after treatment