The aim was to investigate the effect of High-Intensity Focused Electromagnetic technology (HIFEM) on QoL of incontinent patients.(1)High-intensity Focused Electromagnetic technology (HIFEM) triggers intense pelvic floor muscles contractions by targeting neuromuscular tissue and inducing electric currents. Electric currents depolarize neurons resulting in concentric contractions and lift up of all pelvic floor muscles. Key effectiveness is based on focused electromagnetic energy, in-depth penetration, and stimulation of the entire pelvic floor area. The HIFEM technology brings deep PFM stimulation and restoration of the neuromuscular control. The HIFEM passes non-invasively through pelvic floor area. Therefore, it represents a non-invasive solution for incontinent patients, who remain fully clothed during the therapy (2-10, 12, 14-19).
15 women (mean age 63.05 years) with stress, urge and mixed type of UI took part in the pilot study. They attended 6 therapies scheduled 2x a week. QoL was assessed through King’s Health Questionnaire (KHQ). The number of used hygienic pads and patients’ subjective feedback were recorded. Data was collected pre-, post-treatment, during 2- and 4-month follow-ups. KHQ scores were statistically evaluated through t-test (p<0.05). Number of used hygienic pads and patients’ subjective feedback were evaluated through frequency of occurence.3.3. Exclusion criteria
Women with pacemakers, metal implants, blood coagulation disorders, tumors, fever, menstruation and pregnant women were not included in this study. In this pilot study, FDA and EMA approved device for female urinary incontinence treatment BTL EMSELLA (BTL EMSELLA, BTL Industries Inc.) was used.Frequency range 20-30 Hz with trapezoid intensity modulation was used to achieve gradual motor unit recruitment. Relative intensity (in %) was gradually increased from patients’ motor up to above the motor threshold.All women absolved 6 therapies scheduled 2x a week. Therapy was performed by medical personnel, who positioned patients fully dressed into a comfortable sitting position, feet on the floor, hip, knee and ankle joints perpendicularly flexed. 30-minute duration for each treatment session.
After 6 treatments, 95 % of treated patients improved their QoL according to the scores of the KHQ. These results were maintained during the 2- and 4-month follow-ups. 67 % of the treated patients reduced or totally eliminated the use of hygienic pads in day-to-day life. 100 % of patients reported better awareness of the pelvic floor muscles.Additionally, patients answered the question ‘What is the major difference you noticed after the BTL EMSELLA therapies?’40 % of patients reported that they are able to perform proper contraction of the PFM; 28 % of patients were able to contract PFM selectively; 20 % of patients reported better muscle firmness and 12 % of patients reported that the period between micturition is longer. Additionally, all patients (n=15; 100 %) reported better awareness of pelvic floor muscles.
To regain continence, regular pelvic floor muscles exercising is required. Normally, 300-500 contractions of the pelvic floor muscles should be performed to begin to develop a new motor pattern, whereas 3,000-5,000 contractions are required to erase and correct poor motor pattern. During 1 session using HIFEM technology, thousands PFM contractions are performed. This method is extremely important to PFM re-education as the patients are not able to perform this high-repetition rate pattern due to PFM weakness and an inability to consistently contract this muscle group. After 6 therapeutic sessions with HIFEM therapy, patients developed the new motor pattern needed to better control pelvic floor muscles and also regained muscle strength and continence control (3-9, 12-16).
UI represents a significant psycho-socio-economical healthcare problem that has a major negative impact on today’s modern lifestyles. The majority of patients are not satisfied with the current treatment methods offered, which include surgical intervention, drug therapy, pelvic floor muscles exercising (Kegel) or minimally invasive intravaginal procedures. This latest research, as well as, previous studies suggest that HIFEM technology leads to significant improvement in QoL of incontinent patients, maintains a patient’s privacy all while avoiding more invasive approaches.
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