Objective: To evaluate the efficacy and safety of cross-linked hyaluronic acid vaginal injections in women with moderate-to-severe vulvovaginal atrophy (VVA) treated in a pelvic floor rehabilitation unit.
Material and methods: Pilot, quasi-experimental, prospective pre-post study designed to assess safety and detect a preliminary signal of clinical benefit following a single vaginal hyaluronic acid injection, without confirmatory intent. The primary efficacy endpoint was the pre-post change in the Vulvar Health Index (VHI). Eleven women with moderate or severe VVA were included, most with a history of hormone-dependent breast cancer and contraindications to hormonal therapy. A single 1-mL injection of hyaluronic acid was administered, and clinical and functional parameters were assessed using the following tools: VHI, Female Sexual Function Index (FSFI), Visual Analog Scale (VAS) for pain, vulvovaginal symptom questionnaire, dyspareunia grade, Modified Oxford Scale, and the Patient and Clinician Global Impression of Improvement (PGI-I, CGI-I).
Results: At 30 days, VHI improved significantly (11.4±2.9 to 7.8±3.2; p<0.001), FSFI increased (7.2 to 15.3; p=0.008), and pain decreased (VAS: 7.4±1.4 to 3.0±2.4; p<0.001). Overall, 72.7% of patients rated themselves as "very much improved" or "much improved," and no adverse events were reported.
Conclusions: Vaginal hyaluronic acid injections may represent a safe and effective therapeutic option for women with severe VVA, particularly those with oncological history. Larger controlled studies with extended follow-up are needed to confirm these preliminary findings.
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