Simultaneous Application of Hifem with Synchronized Radiofrequency for Improvement of Quality of Life in Elderly Patients: 3-Month Interim Data

Goals/Purpose: The core muscles, such as the abdominal and pelvic floor muscles (PFM), play a significant role in proper posture and protection of the inner organs, with pelvic floor muscles controlling the bladder and bowel, and assisting in sexual function. Deconditioning of core muscles increases the predisposition to injury, incontinence, and sexual dysfunction and worsens the quality of life. Although exercise can improve muscle tone, previous injuries, illnesses, and overall muscle weakness in old age can prevent patients from achieving exercise efficiency. Noninvasive high-intensity focused electromagnetic (HIFEM) procedure, however, is able to induce brain-independent intense muscle contractions referred to as supramaximal, requiring no special commitment or patient cooperation. As a monotherapy, HIFEM effectively strengthens the PFM and in synergy with radiofrequency (RF) also the abdominal muscles. This study aims to investigate the efficiency of the combined use of abdominal and pelvic HIFEM treatments on core muscle strengthening and improvement of quality of life.

Methods/Technique: Thirty-nine patients (60 – 79 years, 19.7 – 33.9 kg/m², skin type I-V) were enrolled in this multicenter, single-arm investigation study. The treatment schedule consisted of four HIFEM+RF abdominal procedures spaced 5-10 days, with six standalone HIFEM procedures on the pelvic floor spaced 2-4 days. Therefore seven (n=7) treatment visits were scheduled, while at the first, third, and fifth treatment visits, both procedures were used consecutively, starting with HIFEM+RF. The follow-up visits were scheduled 1 month and 3 months after the treatments. The HIFEM intensities were set according to a maximum tolerated level, while RF was set at 100%. The changes in the core strength were measured by a biofeedback device. The air-filled pressure pad was placed below the patient's lower back and the patients were instructed to contract their core muscles, resulting in a change of pressure measured in mmHg. The secondary outcomes included waist circumference measurements, a 5-point Likert scale Satisfaction and Therapy comfort questionnaire with a 10-point visual analog pain scale.

Results/Complications: Thirty-eight patients finished the scheduled treatments, with twenty-three subjects have finished 3-month follow-up visit. The preliminary evaluation of the 3-month data from the biofeedback device showed a significant increase in core muscle strength by 52.5% (+28.3 ± 17.01 mmHg, p-value < 0.001), with a maximum difference of 138.1% (+58.0 mmHg). The evaluation of secondary outcomes showed a waist circumference reduction of -2.2 ± 5.12 cm (p-value <0.001) at the 3-month visit, with high satisfaction with the core strength (4.1±0.5), and with the overall outcomes (4.1±0.5) after the treatments. Additionally, patients found procedures comfortable (4.0±0.8) and essentially painless (2.6 ± 2.1). No serious adverse events or side effects occurred.

Conclusion: The evaluation indicates a high efficiency of HIFEM+RF and HIFEM procedures in strengthening the core muscles after the consecutive application to the abdomen and pelvis. The questionnaires revealed high satisfaction with the results and patient comfort during the treatments.