OBJECTIVE: To assess the safety and feasibility of injection of autologous platelet-rich plasma (PRP) into the vagina and posterior fourchette and to evaluate 6-month efficacy for treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors. METHODS: We conducted a prospective, single-arm pilot study of breast cancer survivors (stage 0–III) who reported vaginal dryness with or without dyspareunia. Participants underwent a one-time treatment with 7 mL autologous PRP injected throughout the vaginal canal and posterior fourchette into 35 sites. The primary outcome was to assess safety and feasibility. Secondary outcomes included VMI (Vaginal Maturation Index), VHI (Vaginal Health Index), VAS/VuAS (Vaginal and Vulvar Assessment Scales), DIVA (Day-to-Day Impact of Vaginal Aging questionnaire), FSFI (Female Sexual Function Index), and UDI-6 (Urogenital Distress Inventory–Short Form) scores. Vaginal caliber was measured with silicone dilators. Patient Global Impression of Improvement (PGI-I) was assessed with a 7-point Likert scale. RESULTS: Twenty participants were treated; mean±SD age and body mass index (BMI) were 53.6±7.5 years and 27.2±4.6, respectively. Most had hormone receptor–positive breast cancer (85.0%), and of those, 65.0% were taking an aromatase inhibitor. All participants completed the planned protocol. Treatment adverse events included vaginal spotting, irritation, discharge, burning, cramping, and mild pain, all resolving within 24 hours. No serious adverse events occurred. VAS/VuAS, FSFI, UDI-6, DIVA, VHI, and total scores showed significant improvement from baseline to 6 months; the VMI change was nonsignificant. At 6 months, 90.0% of patients had an increase in vaginal caliber as measured by change in dilator size, and 95.0% noted improvement of symptoms on PGI-I. CONCLUSION: A single treatment of autologous PRP injected diffusely through the vaginal canal and posterior fourchette is safe and feasible. In this uncontrolled pilot trial, at 6 months, treatment significantly improved GSM symptoms, sexual function, urinary symptoms, and quality of life in breast cancer survivors, including those on aromatase inhibitors. CLINICAL TRIAL REGISTRATION: ClnicalTrials.gov, NCT04535323; Cancer.gov, NCT04535323.
Chen et al. (Thu,) studied this question.