Safety and Efficacy of a Non‐Invasive High‐Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life

Abstract

Background and ObjectivesUrinary incontinence is a common and distressing condition which interferes with everyday life. Patients frequently experience discomfort related to urine leakage and the subsequent need to use absorbent pads. Since the continence mechanism is primarily maintained by a proper function of pelvic floor muscles (PFM), many treatment methods focused on strengthening of the PFM have been introduced in the past. The aim of this study was to evaluate the safety and efficacy of a high‐intensity focused electromagnetic technology (HIFEM) for treatment of urinary incontinence with emphasis on effects on prospective patients’ quality of life.Study Design/Materials and MethodsThe study followed an institutional review board approved protocol. A total of 75 women (55.45 ± 12.80 years, 1.85 ± 1.28 deliveries) who showed symptoms of stress, urge, or mixed urinary incontinence were enrolled. They received six HIFEM treatments (2 per week) in duration of 28 minutes. Outcomes were evaluated after the sixth treatment and at the 3‐month follow‐up. The primary outcome was to assess changes in urinary incontinence by the International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐SF) and changes in the number of absorbent pads used per day. The secondary outcome was subjective evaluation of the therapy and self‐reported changes in quality of life. The statistical analysis was conducted by paired T‐test and Pearson correlation coefficient ( α = 0.05).ResultsAfter the sixth session, 61 out of 75 patients (81.33%) reported significant reduction of their symptoms. The average improvement of 49.93% in ICIQ‐SF score was observed after the sixth treatment, which further increased to 64.42% at the follow‐up (both P < 0.001). Individually, the highest level of improvement was reached in patients suffering from mixed urinary incontinence (69.90%). The reduction of absorbent pads averaged 43.80% after the sixth treatment and 53.68% at 3 months (both P < 0.001), while almost 70% of patients (30 out of 43) reported decreased number of used pads. At the follow‐up, a highly significant medium correlation (r = 0.53, P < 0.001) was found between the ICIQ‐SF score improvement and the reduction in pad usage. A substantial decrease in the frequency of urine leakage triggers was documented. Patients reported no pain, downtime or adverse events, and also reported additional beneficial effects of the therapy such as increased sexual desire and better urination control.ConclusionsThis study demonstrated that HIFEM technology is able to safely and effectively treat a wide range of patients suffering from urinary incontinence. After six treatments, an improvement in ICIQ‐SF score and reduction in absorbent pads usage was observed. Based on subjective evaluation, these changes positively influenced quality of life. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Assessment of the Short-Term Effects after High-Inductive Electromagnetic Stimulation of Pelvic Floor Muscles: A Randomized, Sham-Controlled Study

“…In addition, individuals with (6) any neurological symptoms; (7) systemic diseases; (8) diabetes mellitus; (9) lumbar or pelvic pain in the last 6 months were excluded [9,10,30]. Participants were also excluded if they had (10) any contraindications for HIES (pregnancy, cancer, heart pacemaker, hearing aid or other non-removable electronic devices, bleeding of any origin, pain of unknown origin, neurological diseases, epilepsy, very low blood pressure, metal pieces within the area of HIES application, radiotherapy or chemotherapy, malaise during the examination or infection of the urogenital tract) [13,14,29]; (11) allergy to nickel [9,30,32]; (12) the occurrence of pain during the study [9,30,32]; or (13) resignation during the study [9,30,32].…”

“…The intervention (a single-session intervention) in the HIES group included local 20 min HIES with an electromagnetic induction intensity of 2.5 T [13,14,29]. The SOLUS TALEN device (REMED, Daejeon, South Korea, Figure 1) was used to conduct HIES.…”

“…Physiotherapy (including physical therapy) should be performed by patients with these types of symptoms to increase the strength and endurance of the pelvic floor muscles (PFMs) as well as increase the elasticity of the pelvic floor structures [6][7][8][9][10]. It seems that one of the methods of physical therapy that may positively affect the pelvic floor is stimulation with high-inductive electromagnetic stimulation (HIES; high-inductive, deep-penetrating, pulsed electromagnetic stimulation) [11][12][13][14]. The use of other physical therapy in the treatment of SUI has been described in the literature [15][16][17][18], and electrotherapy is mainly used [16][17][18].…”

“…The new electromagnetic stimulation notably differs from perceptible tingling and tissue vibration during the treatment. Manufacturers recommend HIES as an effective, comprehensive, noninvasive and safe method for the treatment of SUI [13,14,29]. Its effects on peripheral nerve stimulation, muscle activation and effectiveness in improving the composition of collagen structures and blood circulation have been highlighted [12][13][14].…”

“…The impact of stimulation with HIES (a single-session intervention) on the pelvic floor structures in women with SUI or MUI is the foundation of this research project, as there is evidence that it can influence the tissue-healing process, improve neural tissue regeneration, increase elasticity and tissue perfusion and alleviate pain in people with chronic conditions [12][13][14]24,25]. The lack of randomized studies with a sham intervention on the impact of HIES on the pelvic floor muscles prompts this type of study [13,14].…”