Safety And Preliminary Efficacy of Magnetic Stimulation of Pelvic Floor with Hifem Technology in Urinary Incontinence
Delgado Cidranes E1 * and Estrada Blanco2
Journal Title:Medical & Clinical Research
Introduction: BTL EMSELLA™ utilizes High-Intensity Focused Electromagnetic technology (HIFEM) to cause deep pelvic floor muscles stimulation and restoration of the neuromuscular control. Key effectiveness is based on focused electromagnetic energy, in-depth penetration and stimulation of the entire pelvic floor area. A single BTL EMSELLA™ session brings thousands of supramaximal pelvic floor muscle contractions, which are extremely important in muscle reeducation of incontinent patients. Objective: Prospective study to evaluate the safety and preliminary effectiveness of the use of BTL EMSELLA magnetic stimulation in urinary incontinence. Method: Thirty-two patients with light and moderate urinary incontinence were recruited to perform 6 sessions of BTL EMSELLA during three weeks of initial treatment. Follow-up after three months. The patients received sessions lasting 28 minutes, completing the different treatment protocols. Initially the patients underwent a quality of life test before and after treatment, evaluation with advanced ultrasound using elastography to measure the initial tissue's elasticity and be able to compare after treatment, clinical functional evaluation and urodynamic test. Results: No adverse reactions were observed. All the patients finished the treatment sessions. Two patients reported increased pain after treatment in the first session corresponding to a VAS scale greater than 5 with duration greater than three hours. The treatment was highly satisfactory in 84,4% of the patients. After the first three months the improvement was maintained in 77% of the patients. No muscle injuries were observed. Elastographic changes and improvement of muscle tone were detected by advanced ultrasound (elastography) in 100% of patients. Conclusions: BTL EMSELLA is safe, well tolerated and effective for the treatment of mild and moderate urinary incontinence. The observed elastographic changes demonstrate the improvement of pelvic floor muscle tone after treatment. A reduction in the symptoms of urinary incontinence was demonstrated. Recommendations: Continue increasing the number of cases for research and increase the variables that we have decided to incorporate in the next research section such as MRI and pressure calculation.