The Improvement of Quality of Life in Female Patients after Childbirth By Hifem with Synchronized Radiofrequency for the Strengthening of Core Muscles
Methods/Technique: Thirty-six female subjects were enrolled in this multicentre, single-arm, open-label, interventional study. The treatment schedule consisted of seven visits, four HIFEM+RF abdominal procedures spaced 5-10 days apart, and six standalone HIFEM procedures on the pelvic floor spaced 2-4 days apart. Both procedures were used consecutively in the first, third, and fifth treatment visits, starting with HIFEM+RF. The follow-up visits were scheduled 1 month and 3 months after the treatments. The primary evaluation included measuring the core strength by a pressure biofeedback device and waist circumference. 5-point Likert scale questionnaires documenting patients’ satisfaction and comfort were used, including a 10-point visual analog pain scale (VAS).
Results/Complications: Thirty patients (31-42 years, BMI 22.7 – 34.5 kg/m2) underwent the measurements after the last treatment, with eleven patients finishing the 1-month follow-up visit. The preliminary evaluation of muscle strength showed a 14.1% (+14.7±15.05 mmHg, p-value<0.001) increase after the last treatment with a 36.4% (+32.9±19.7 mmHg, p-value<0.05) increase at 1-month follow-up. The waist circumference was reduced by 1.5±1.8 cm and 3.7±2.5 cm (both p-value<0.001) after the last treatment and at 1 month, respectively. Patients found the combined treatment comfortable (3.9±0.9) and painless (VAS=2.7±2.1). Additionally, 1 month after the last treatment, the patients reported a stronger core (4.3±0.5), being more comfortable in their clothes (3.7±0.5), and spending quality time with their children (3.8±0.6). No adverse events or side effects were observed.
Conclusion: Preliminary analysis suggests substantial effectiveness of the consecutive use of HIFEM+RF abdominal procedure followed by pelvic floor therapy with standalone HIFEM for strengthening the core muscles, resulting in quality of life improvements along with high satisfaction.
