IMPACT OF MICROABLATIVE FRACTIONAL RADIOFREQUENCY ON VAGINAL HEALTH, SEXUAL FUNCTION, URINARY SYMPTOMS, AND QUALITY OF LIFE IN BREAST CANCER SURVIVORS WITH GENITOURINARY SYNDROME OF MENOPAUSE
Breast neoplasms; Cancer survivors; Atrophy; Radiofrequency therapy; Laser therapy
Introduction: Breast cancer survivors (BCS) often experience more severe symptoms of genitourinary syndrome of menopause (GSM). As estrogen-based hormonal therapy is generally avoided in BCS, physical energy methods may offer promising non-hormonal alternatives. However, the efficacy and safety of these treatments remain controversial.
Objective: To assess the safety and efficacy of vaginal microablative fractional radiofrequency (MAFRF) versus sham treatment in breast cancer survivors with genitourinary syndrome of menopause (GSM).
Methods: This prospective, single-blind, randomized, sham-controlled clinical trial was conducted from February to December 2025. Eligible breast cancer survivors with GSM were randomly assigned to receive vaginal MAFRF or sham treatment. Follow-up assessments occurred one-month post-intervention. The primary outcome was sexual function assessed by the Female Sexual Function Index (FSFI) and symptom severity (dyspareunia, dysuria, vaginal dryness) measured by a visual analogue scale (VAS). Secondary outcomes included vaginal health assessed by Vaginal Health Index (VHI), Quality of Life Using a Short Form Health Survey (SF-12), and urinary symptoms assessed by self-administered questionnaires of International Consultation on Incontinence Questionnaire (ICIQ-UI) and Overactive Bladder (ICIQ-OAB). Data were analyzed in March 2026. Tolerance, and adverse effects were recorded.
Results: Among 218 survivors of breast cancer, 80 women (mean [SD] age, 50 [7] years) were eligible to randomized and analyzed in MAFRF (43 patients) or Sham group (37 patients). At one month, both groups showed improvements in FSFI (mean [SD] score at baseline vs one-month: MAFRF 14.89 [7.04] to 17.48 [8.28], Sham group 13.73 [6.45] to 17.97 [8.67], but there was no significant difference in change between groups (mean difference in change, −1.64 [95% CI, −4.74 to 1.45]; P = .294). There were also no statistically significant differences between groups in change from baseline on subjective GSM symptoms including dyspareunia (mean difference in change, −0.71 [95% CI, −2.09 to 0.68]; P = .312), vaginal dryness (mean difference in change, −0.99 [95% CI, −2.64 to 0.64]; P = .229), and dysuria (mean difference in change, −0.75 [95% CI, −0.81 to 2.31]; P = .343). In the MAFRF group, significant improvements were observed in vaginal VHI (mean difference in change, 4.25 [95% CI, 3.20 to 5.30]; P < .001) and objective vaginal pH (mean difference, −0.60 [95% CI, −0.81 to −0.39]; P < .001). Quality-of-life analyses demonstrated significant improvements in physical health domains favoring the MAFRF group (mean difference, 3.67 [95% CI, 0.11 to 7.24]; P = .043). No differences between-group were found in urinary symptom questionnaires, including ICIQ-UI and ICIQ-OAB scores. Both interventions were well tolerated, although tolerability scores were slightly lower in the sham group No major adverse events were observed.
Conclusions: In this randomized trial, vaginal microablative fractional radiofrequency did not demonstrate significant benefits over sham treatment in improving subjective sexual function outcomes or GSM symptoms. Nevertheless, demonstrated a favorable safety profile and significant improvements in objective vaginal health parameters and physical quality of life. These early findings support further investigation of this therapy in breast cancer survivors.
Clinical Trials Registry (ReBec): RBR-2ntr3yd