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.

BACKGROUND AND OBJECTIVES: Urinary 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 METHODS: The 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). RESULTS: After 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. CONCLUSIONS: This 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.

Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Background: Increasingly, women have sought alternatives to traditional options (lubricants, estrogen products, and hormone replacement therapy) for unwelcome vaginal changes of menopause. Objectives: This study evaluated whether a series of three monthly fractional CO2 laser treatments significantly improves and maintains vaginal health indices of elasticity, fluid volume, pH level, epithelial integrity, and moisture. Self-reported symptoms of vaginal atrophy were also measured. Biopsy samples after a series of three treatments were evaluated for histological changes to vaginal canal tissue. Methods: Forty postmenopausal women were treated extravaginally and internally with a fractional CO2 laser. Objective measurements of vaginal health index, as well as subjective measurements of symptoms of vulvovaginal atrophy (VVA), urinary incontinence, and sexual function were reported at baseline. Follow-up evaluations were at one, three, six, and 12 months after the third treatment. Results: Vaginal health index improved significantly after the first treatment and was maintained with mean improvement of 9.6 ± 3.3 (P < 0.001) and 9.5 ± 3.3 (P < 0.001) at the 6- and 12-month follow ups, respectively. Vaginal symptoms of dryness, itching, and dyspareunia improved significantly (P < 0.05) at all evaluations. Histological findings showed increased collagen and elastin staining, as well as a thicker epithelium with an increased number of cell layers and a better degree of surface maturation. Conclusions: Fractional CO2 laser treatments were well tolerated and were associated with improvement in vaginal health and amelioration of symptoms of VVA. Histological changes in the epithelium and lamina propria, caused by fractional CO2 laser treatments, correlated with clinical restoration of vaginal hydration and pH to premenopausal levels.

Radiofrequency Heating and High-Intensity Focused Electromagnetic Treatment Delivered Simultaneously: The First Sham-Controlled Randomized Trial.

BACKGROUND: Radiofrequency-based and high-intensity focused electromagnetic (HIFEM)-based devices have proved effective and safe for abdominal body shaping. Radiofrequency is known to reduce adipose tissue, whereas HIFEM treatment is effective for muscle definition. The authors investigated the efficacy of a novel device delivering synchronized radiofrequency and HIFEM treatment simultaneously for abdominal toning and fat reduction. METHODS: Seventy-two patients were enrolled and randomly divided into active (n = 48; age, 45.5 ± 13.0 years) and sham groups (n = 24; age, 44.6 ± 12.3 years). Both groups received three treatments on the abdomen once a week. The intensity in the active group was set to maximum tolerable level; in the sham group, the intensities were set to 5 percent. Ultrasound images were taken before treatment and at 1, 3, and 6 months after treatment to examine changes in subcutaneous fat and rectus abdominis muscle thickness. Digital photographs were taken, and satisfaction and therapy comfort were assessed. RESULTS: Ultrasound images of the active group at 1 month showed significant (p < 0.05) reduction in adipose tissue thickness by 20.5 percent (4.8 ± 2.6 mm), whereas rectus abdominis muscle thickness increased by 21.5 percent (2.0 ± 0.8 mm). Results at 3 months improved to 28.3 percent (7.6 ± 3.7 mm) and 24.2 percent (2.3 ± 0.9 mm), respectively. Improvements were maintained at 6 months after treatment in the active group, whereas the sham group showed no significant changes. Treatments were found to be comfortable. The active group showed higher satisfaction with outcomes. CONCLUSION: Active treatment utilizing simultaneous application of radiofrequency and HIFEM therapy resulted in a significant increase in rectus abdominis thickness and subcutaneous fat reduction, exceeding previously published results for separate HIFEM and radiofrequency treatments. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.