Efficacy and Safety of Energy-Based Device Therapy in Women Diagnosed with Vaginal Relaxation Syndrome: A Systematic Review and Meta-analysis

INTRODUCTION AND HYPOTHESIS: To evaluate the efficacy and safety of energy-based devices (EBDs) in the treatment of vaginal relaxation syndrome (VRS). METHODS: Systematic search of PubMed, EMBASE, Web of Science, MEDLINE, Clinicaltrials.gov, and Cochrane Library through September 2024. Studies were eligible if they evaluated EBDs for the management of VRS and reported outcomes related to treatment efficacy, side effects, and follow-up data. Two reviewers independently screened titles, abstracts, and full texts, extracted data, and assessed study quality. Meta-analyses were performed when appropriate. This systematic review was conducted and reported in accordance with the PRISMA guidelines. RESULTS: Thirty-four studies (7 RCTs, 27 OSs; 1775 participants) were included. RCTs showed improvement in Female Sexual Function Index (FSFI) and Vaginal Laxity Questionnaire (VLQ) scores after laser or radiofrequency (RF) treatment (P > 0.05). OSs demonstrated significant increases in FSFI, VLQ, and Vaginal Health Index scores (all P < 0.05). RF improved Sexual Satisfaction Questionnaire and Female Sexual Distress Scale-Revised scores (P < 0.05). PISQ-12 scores also improved posttreatment (P < 0.05). Mild side effects resolved within 1-2 days. CONCLUSION: Current evidence, which mainly comes from observational studies with substantial bias, suggests that EBDs improve vaginal health and sexual function in women with VRS. However, owing to limitations in study quality, further high-quality, large-scale RCTs are needed.