A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)
The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment of women with stress urinary incontinence (SUI), urge incontinence (UI) and mixed stress urinary and urge incontinence (MUI), looking at any potential sexual health benefits that may be concomitantly achieved from this treatment.
• Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
• Subject is female;
• Subject is aged 21-80 years;
• 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 currently sexually active and willing to continue sexual activity throughout the study;
• 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.