임상 논문

Electromagnetic treatments have recently been combined with radiofrequency to reduce the fat layer and simultaneously increase muscle thickness. Studies report treatment efficacy, using photographs and imaging methods. A literature review was conducted. Measurement data were tabulated. The EmSculpt Neo device (BTL Industries, Boston, MA) was used in all studies. Seven studies evaluated the fat thickness and muscle thickness using either ultrasound (1 study) or magnetic resonance imaging methods (6 studies). The abdomen was treated in 2 studies. The other studies treated the lateral thighs, flanks, buttocks, inner thighs, and upper arms. The mean reduction in fat thickness was 8.0 mm, and the mean increase in muscle thickness was 5.5 mm. All 7 studies were authored by BTL medical advisors. Measured changes were likely within the margin of error and of questionable clinical relevance. Few adverse events were reported. Photographs were frequently not standardized, showing changes in treated areas, but unexplained changes in nontreated areas as well. The magnetic resonance imaging scans were affected by differing levels of the axial slice. Measured changes were incremental and likely not indicative of a true treatment effect. The scientific basis for efficacy is tenuous, both for fat reduction and muscle hypertrophy. A scientific evaluation of the results fails to produce reliable evidence of a clinically meaningful result for this combination energy-based treatment. Financial conflict is a major factor. Liposuction remains the gold standard. Emsculpt Neo (EmSculpt NEO Device, BTL Industries, Inc.) is a FDA-cleared noninvasive body contouring treatment for increasing muscle tone and/or reducing fat. The device uses high-intensity electromagnetic energy to stimulate muscle contractions and to build muscle mass (Emsculpt) or a combination of electromagnetic energy with radiofrequency (Emsculpt NEO) to produce a synergistic effect of building muscle mass and reducing fat. In this study, we conduct a high-quality systematic review to evaluate outcomes for Emsculpt and Emsculpt NEO treatments for noninvasive body contouring. An electronic search was performed of the PubMed, MEDLINE, Embase, and Web of Science databases using the key terms "High intensity focused electromagnetic therapy; HIFEM; Emsculpt; Emsculpt NEO; BTL Industries." The search included all articles published in English through January 2023. Inclusion criteria included articles noninvasive body contouring and reporting at least one outcome of interest (clinical or patient-reported outcomes). Methodological quality and risk of bias were assessed using the GRADE criteria. Articles involving applications other than for body contouring, animal studies, and review articles were excluded. Of the 159 articles identified in the initial search strategy, 51 met relevance based on abstract screening. Fifteen clinical studies were identified, including Emsculpt (n=11) and Emsculpt NEO (n=2). The typical protocol involved four treatments given over a 2-4-week period (range 3-8 treatments) with increase to 100% intensity setting and 1-6-month follow-ups. No complications were reported. Abdominal measurements were obtained using imaging were reported in eight studies. Treated areas included the buttocks (n=4), thighs (n=3), arms or calves (n=1), and abdomen (n=11). For abdominal contouring, mean reductions of fat thickness were 5.5 mm, muscle thickness of 2 mm, and rectus diastasis improvement of 3.0 mm. No studies reported weight change before and after treatment. All studies with patient-reported outcomes report high patient satisfaction. Two studies report marginal or no benefit of treatment. Certain studies failed to report comorbidities or demographic characteristics other than age and sex, which precludes analysis of specific subgroups that may benefit from treatment. Furthermore, certain studies failed to address how missing data or the final study population was analyzed. This systematic review reports on currently published evidence regarding the efficacy and safety of Emsculpt and Emsculpt NEO for body contouring. High-quality level data reporting with patient-reported outcomes will optimize shared decision-making and informed consent. Therapeutic study. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Energy-based treatments include ultrasound, lasers, cryolipolysis, and radiofrequency. The most recent energy treatment for noninvasive body contouring is electromagnetic treatments-a hot topic in plastic surgery today. A systematic review to assess efficacy and safety has not been published. An electronic search was performed using PubMed to identify the literature describing electromagnetic treatments. Measurements from imaging studies were tabulated and compared. Fourteen clinical studies were evaluated. Two studies included simultaneous radiofrequency treatments. In 11 studies, the Emsculpt device was used; in 2 studies, the Emsculpt-Neo device was used. One study included a sham group of patients. The usual protocol was 4 treatments given over a 2-week period. No complications were reported. Eight studies included abdominal measurement data obtained using magnetic resonance imaging, computed tomography, or ultrasound. Photographic results were typically modest. Photographs showing more dramatic results also showed unexplained reductions in untreated areas.Measurement variances were high. The mean reduction in fat thickness was 5.5 mm. The mean increment in muscle thickness was 2.2 mm. The mean decrease in muscle separation was 2.9 mm (P = 0.19). Early posttreatment ultrasound images in 1 study showed an echolucent muscle layer, compared with a more echodense layer at the baseline, consistent with tissue swelling after exercise. Almost all studies were authored by medical advisors for the device manufacturer. Measurement data show small reductions in fat thickness, occurring almost immediately after the treatments. Adipocyte removal without tissue swelling would be unique among energy-based treatments. Similarly, muscle hypertrophy is not known to occur acutely after exercise; muscle swelling likely accounts for an early increment in muscle thickness. Any improvement in the diastasis recti is likely fictitious. Electromagnetic treatments, either administered alone or in combination with radiofrequency, are safe. However, the evidence for efficacy is tenuous. Measured treatment effects are very small (<5 mm). Conflict of interest and publication bias are major factors in studies evaluating energy-based alternatives. The evidence-based physician may not be satisfied that an equivocal treatment benefit justifies the time and expense for patients.

Urinary incontinence (UI) is a common complication after radical prostatectomy (RP), adversely affecting patients' quality of life. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic (HIFEM) therapy as a non-invasive treatment for post-prostatectomy UI. Twenty-seven men (mean age ± SD: 67.9 ± 3.4 years) with persistent UI after RP underwent six HIFEM sessions (28 min, twice weekly) using the BTL EMSELLA® chair. Outcomes were assessed after the sixth session and at one-month follow-up. Primary endpoints were changes in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores and daily pad use. Baseline mean ICIQ-SF score was 10.58 ± 4.15. This decreased to 5.43 ± 3.85 after treatment and to 4.16 ± 3.97 at one month, representing improvements of 53.1% and 60.6%, respectively (both p < 0.005). Daily pad use declined from baseline to 1.45 ± 1.54 after treatment and 1.13 ± 1.81 at follow-up (both p < 0.001). No adverse events were reported. HIFEM therapy significantly improved UI severity and reduced pad dependence in men with post-prostatectomy incontinence, with effects sustained for at least one month and no observed side effects. These findings support HIFEM as a safe, non-invasive treatment option warranting further study in larger, long-term trials. Background: This prospective comparative study investigates urinary incontinence (UI), often associated with grade 2 cystocele, a condition that poses significant physical, emotional, and social challenges for affected women. While anterior colporrhaphy remains the gold standard for anatomical correction, non-invasive alternatives such as EMSella therapy have gained increasing attention. The study compares the outcomes of these two distinct approaches in managing UI and the associated pelvic organ prolapse. Materials and Methods: This study involved 133 menopausal women with grade 2 cystocele and UI, including 78 treated with anterior colporrhaphy and 55 with EMSella therapy, across two Romanian healthcare centers. Outcomes were assessed through prolapse reduction (POP-Q), bladder function normalization, recurrence rates, quality of life (PFDI-20, PFIQ-7), patient satisfaction, complication rates, recovery times, and social or professional disruptions. Results: Anterior colporrhaphy was more effective in anatomical correction (88% vs. 64% achieving stage 0 prolapse) and bladder function normalization (72% vs. 55%, p = 0.04), with lower one-year recurrence rates (14% vs. 31%, p = 0.03). EMSella therapy allowed faster recovery, with 91% resuming daily activities within a week. Both groups showed improvement in quality of life, but reductions in PFDI-20 and PFIQ-7 scores were more significant after surgery. EMSella had fewer infections and no dyspareunia, reflecting a better safety profile. Conclusions: EMSella therapy and anterior colporrhaphy significantly benefit managing UI associated with grade 2 cystocele. While anterior colporrhaphy provides definitive anatomical correction and superior long-term outcomes, EMSella therapy represents a safer, less invasive alternative with rapid recovery, making it ideal for patients with mild conditions or surgical contraindications. Treatment should be tailored to individual patient needs and preferences. To assess the effectiveness and safety of high-intensity focused electromagnetic technology (HIFEM) used as a therapeutic approach in patients with stress and mixed urinary incontinence. Thirty-five females suffering from stress and mixed urinary incontinence were included in the study. The electromagnetic chair (BTL EMSELLA®) was applied to the patient's pelvic area twice a week for 28 minutes, totaling 6 sessions. The patients' "International Consultation on Incontinence Questionnaire-Short Form" (ICIQ-SF) scores and the number of daily absorbent pad usage were recorded. Results were evaluated after the sixth session and at a first-month follow-up. The average ICIQ-SF score at baseline was 10.18 ± 4.19 (ranging from 2-18) which declined to 5.33 ± 3.97 after six sessions, and further improved to 4.26 ± 3.94 points at the one-month follow-up. After six sessions, an average improvement of 52.06% in ICIQ-SF score was observed, and after one month of follow-up, an average improvement of 59.6% was detected, which was found to be statistically significant (p=0.038). In addition, the mean number of pads used per day decreased to 1.25 ± 1.54 after treatment, a significant improvement was observed, and the mean daily pad use decreased further to 0.91 ± 1.11 at the first-month follow-up. HIFEM has demonstrated in our study its ability to safely and effectively treat female patients suffering from stress and mixed urinary incontinence, as evidenced by significant improvements in symptoms and quality of life observed in clinical trials. Urinary incontinence (UI) is a common global condition that has been noted to disproportionately affect women. In this review, the authors present discussion of factors contributing to cost of care and various modalities of cost-effective care for UI for female patients. We found insurance and out-of-pocket (OOP) costs strongly impact of costs for patients. Further, in evaluation of UI, diagnosis can be a costly multi-step process for effective treatment. Treatment can be multimodal, including non-surgical (e.g., pessary, vaginal insert, pelvic floor muscle training, or PFMT), of which PFMT is a cost-effective, effective, and accessible treatment. Pharmacologic management is generally second-line for overactive bladder, but anti-muscarinic drugs and beta-3 agonists are cost-effective depending on willingness-to-pay and the health system in which they are acquired, respectively. Surgical management is considered the most cost-effective treatment as willingness-to-pay increased, with minimally invasive slings being the mainstay. Other relatively novel treatments are also discussed (e.g., EMSELLA) but require further research. Additionally, we discuss systematic barriers in decisions to seek care for urinary incontinence. Urologists are key agents in treating UI for their female patients, and seeking cost-effective options for treatment remains pivotal for quality care.

Urinary incontinence (UI) is a common complication after radical prostatectomy (RP), adversely affecting patients' quality of life. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic (HIFEM) therapy as a non-invasive treatment for post-prostatectomy UI. Twenty-seven men (mean age ± SD: 67.9 ± 3.4 years) with persistent UI after RP underwent six HIFEM sessions (28 min, twice weekly) using the BTL EMSELLA® chair. Outcomes were assessed after the sixth session and at one-month follow-up. Primary endpoints were changes in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores and daily pad use. Baseline mean ICIQ-SF score was 10.58 ± 4.15. This decreased to 5.43 ± 3.85 after treatment and to 4.16 ± 3.97 at one month, representing improvements of 53.1% and 60.6%, respectively (both p < 0.005). Daily pad use declined from baseline to 1.45 ± 1.54 after treatment and 1.13 ± 1.81 at follow-up (both p < 0.001). No adverse events were reported. HIFEM therapy significantly improved UI severity and reduced pad dependence in men with post-prostatectomy incontinence, with effects sustained for at least one month and no observed side effects. These findings support HIFEM as a safe, non-invasive treatment option warranting further study in larger, long-term trials. Background: This prospective comparative study investigates urinary incontinence (UI), often associated with grade 2 cystocele, a condition that poses significant physical, emotional, and social challenges for affected women. While anterior colporrhaphy remains the gold standard for anatomical correction, non-invasive alternatives such as EMSella therapy have gained increasing attention. The study compares the outcomes of these two distinct approaches in managing UI and the associated pelvic organ prolapse. Materials and Methods: This study involved 133 menopausal women with grade 2 cystocele and UI, including 78 treated with anterior colporrhaphy and 55 with EMSella therapy, across two Romanian healthcare centers. Outcomes were assessed through prolapse reduction (POP-Q), bladder function normalization, recurrence rates, quality of life (PFDI-20, PFIQ-7), patient satisfaction, complication rates, recovery times, and social or professional disruptions. Results: Anterior colporrhaphy was more effective in anatomical correction (88% vs. 64% achieving stage 0 prolapse) and bladder function normalization (72% vs. 55%, p = 0.04), with lower one-year recurrence rates (14% vs. 31%, p = 0.03). EMSella therapy allowed faster recovery, with 91% resuming daily activities within a week. Both groups showed improvement in quality of life, but reductions in PFDI-20 and PFIQ-7 scores were more significant after surgery. EMSella had fewer infections and no dyspareunia, reflecting a better safety profile. Conclusions: EMSella therapy and anterior colporrhaphy significantly benefit managing UI associated with grade 2 cystocele. While anterior colporrhaphy provides definitive anatomical correction and superior long-term outcomes, EMSella therapy represents a safer, less invasive alternative with rapid recovery, making it ideal for patients with mild conditions or surgical contraindications. Treatment should be tailored to individual patient needs and preferences. To assess the effectiveness and safety of high-intensity focused electromagnetic technology (HIFEM) used as a therapeutic approach in patients with stress and mixed urinary incontinence. Thirty-five females suffering from stress and mixed urinary incontinence were included in the study. The electromagnetic chair (BTL EMSELLA®) was applied to the patient's pelvic area twice a week for 28 minutes, totaling 6 sessions. The patients' "International Consultation on Incontinence Questionnaire-Short Form" (ICIQ-SF) scores and the number of daily absorbent pad usage were recorded. Results were evaluated after the sixth session and at a first-month follow-up. The average ICIQ-SF score at baseline was 10.18 ± 4.19 (ranging from 2-18) which declined to 5.33 ± 3.97 after six sessions, and further improved to 4.26 ± 3.94 points at the one-month follow-up. After six sessions, an average improvement of 52.06% in ICIQ-SF score was observed, and after one month of follow-up, an average improvement of 59.6% was detected, which was found to be statistically significant (p=0.038). In addition, the mean number of pads used per day decreased to 1.25 ± 1.54 after treatment, a significant improvement was observed, and the mean daily pad use decreased further to 0.91 ± 1.11 at the first-month follow-up. HIFEM has demonstrated in our study its ability to safely and effectively treat female patients suffering from stress and mixed urinary incontinence, as evidenced by significant improvements in symptoms and quality of life observed in clinical trials. Urinary incontinence (UI) is a common global condition that has been noted to disproportionately affect women. In this review, the authors present discussion of factors contributing to cost of care and various modalities of cost-effective care for UI for female patients. We found insurance and out-of-pocket (OOP) costs strongly impact of costs for patients. Further, in evaluation of UI, diagnosis can be a costly multi-step process for effective treatment. Treatment can be multimodal, including non-surgical (e.g., pessary, vaginal insert, pelvic floor muscle training, or PFMT), of which PFMT is a cost-effective, effective, and accessible treatment. Pharmacologic management is generally second-line for overactive bladder, but anti-muscarinic drugs and beta-3 agonists are cost-effective depending on willingness-to-pay and the health system in which they are acquired, respectively. Surgical management is considered the most cost-effective treatment as willingness-to-pay increased, with minimally invasive slings being the mainstay. Other relatively novel treatments are also discussed (e.g., EMSELLA) but require further research. Additionally, we discuss systematic barriers in decisions to seek care for urinary incontinence. Urologists are key agents in treating UI for their female patients, and seeking cost-effective options for treatment remains pivotal for quality care.