The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial

• Published in: Lasers in medical science 2022-04, Vol.37 (3), p.1829-1842
• Main Authors: Wattanakrai, Penpun, Limpjaroenviriyakul, Nattawan, Thongtan, Darin, Wattanayingcharoenchai, Rujira, Manonai, Jittima
• Format: Article
• Language: English
• Subjects: Burning; Clinical trials; Dentistry; Electromagnetic Fields; Electromagnetism; Female; Females; Histology; Humans; Indexing; Lasers; Medicine; Medicine & Public Health; Muscles; Optical Devices; Optics; Original; Original Article; Pain; Pain perception; Photonics; Prospective Studies; Quantum Optics; Radio frequency; Safety; Sensation; Technology; Treatment Outcome; Vagina; Vagina - pathology
• ISSN: 1435-604X; 0268-8921; 1435-604X
• DOI: 10.1007/s10103-021-03438-3

Non-invasive vaginal rejuvenation with radiofrequency (RF) and lasers devices have gained popularity, but well-designed studies confirming their effectiveness are lacking. The aim of this study was to compare the efficacy and safety of a multipolar RF and pulsed electromagnetic field-based device (PEMF) versus sham for vaginal laxity. Thirty-two premenopausal females with ≥ 1 vaginal delivery and self-reported vaginal laxity were randomized into 2 groups: active (RF + PEMF) and sham. Both groups received 3 vaginal treatments at 3-week interval. The Vaginal Laxity Questionnaire (VLQ), perineometer measurements, and Brink score were conducted at baseline, 4, and 12 weeks after treatments. Pre and post-treatment vaginal histology, Female Sexual Function Index (FSFI), subjects’ satisfaction, pain, and adverse events were assessed. The active group VLQ scores increased and were significantly better than the sham group ( p   4) versus 12% in the sham group ( p  = 0.054). In the active group, all domains of perineometer measurements and Brink scores ( p