Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study.

Abstract

Approximately 50% to 70% of breast cancer survivors are affected by one or more symptoms of vulvovaginal atrophy (VVA). For those who cannot take hormone therapy, autologous platelet-rich plasma combined with hyaluronic acid (A-PRP-HA) may provide a new alternative therapy for the treatment of VVA in postmenopausal women with history of breast cancer. We enrolled 20 postmenopausal breast cancers survivors with VVA and a score of <15 on the Gloria Bachman Vaginal Health Index (VHI) comprised of five items including: vaginal pH, elasticity, fluid volume (secretions), epithelial integrity, and moisture.We administered intramucosal injections of A-PRP combined with HA (Regenkit) and performed clinical evaluations at 0, 1, 3, and 6 months. Primary endpoint: evaluation of vulvovaginal mucosa changes using the VHI; secondary endpoint: evaluation of dyspareunia and sexual dysfunction based on the Female Sexual Distress (FSD) score. All participants (20 women) showed improvement in the clinical symptoms of vaginal dryness and dyspareunia. The VHI score showed a significant increase at 6 months, going from a total baseline score (pretreatment) of 10.7 ± 2.12 to 20.75 ± 4.8 (P < 0.0001) at 6 months. Improvement in hydration and vaginal epithelial integrity was reported. A VHI score of > 15 showed a successful treatment outcome. The FSD score decreased significantly during the study, from a baseline score of 36.35 ± 2.53 pretreatment to 30.15 ± 2.47 6 months after treatment, representing improvement of 17% (P < 0.0001, respectively). No adverse events were reported. The injection of A-PRP-HA appeared to be a promising method to improve the trophicity and hydration of vaginal mucosa for the treatment of VVA in postmenopausal breast cancer survivors with contraindications to hormone therapy.