OBJECTIVE: To assess changes in sexual function in women randomized to anterior vaginal wall injection with platelet-rich plasma (PRP) or saline placebo. METHODS: This pilot single-center, single-blind, randomized controlled trial enrolled sexually active premenopausal women 18–50 years of age without severe sexual dysfunction. Participants were randomized to either PRP or control (saline) one-time injection into the distal anterior vaginal wall and followed up for 6 months. The primary outcome was change in FSFI (Female Sexual Function Index) score at 6 weeks. RESULTS: Fifty-two participants were randomized, 26 (50.0%) to PRP and 26 (50.0%) to control. In women treated with PRP, the median total FSFI score showed a greater increase at 6 weeks and 6 months after injection compared with women in a control group (6-week score change for total FSFI score: PRP 2.2 95% CI, 0.6–4.8, control 0.3 95% CI, −1.7 to 2.3; 6-month change: PRP 1.6 95% CI, −0.2 to 4.1, control 0.8 95% CI, −1.1 to 2.7, P =.05). Women treated with PRP demonstrated improved FSFI subscale scores for desire (6-week change score 0.6 95% CI, 0.1–1.1), arousal (0.8 95% CI, 0.2–1.2), lubrication (0.7 95% CI, 0.2–1.2), and orgasm (1.0 95% CI, 0.1–1.5), although these changes were not statistically significantly different compared with control. The percentage of participants reporting improved sexual function based on the PGI-I (Patient Global Impression of Improvement) score was higher in the PRP group at 6 weeks (69.2% PRP vs 42.3% control, P =.05) and at 6 months (69.2% PRP vs 34.6% control, P =.01). No serious adverse events were reported. CONCLUSION: This randomized controlled trial provides compelling data demonstrating greater improvement in sexual function with anterior wall PRP injections compared with control in sexually active premenopausal women without severe sexual dysfunction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05769283.
Clarke et al. (Thu,) studied this question.