Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, Pavia, Italy.
Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
Climacteric. 2020 Oct;23(5):519-524. doi: 10.1080/13697137.2020.1754386. Epub 2020 May 12.
This study aimed to assess the efficacy and safety of hyaluronic acid-based vaginal pessaries (Hydeal-D) in the treatment of vulvovaginal atrophy (VVA). The study was a prospective, multicenter clinical investigation of VVA topical treatment in 40 postmenopausal women. Patients applied one Hydeal-D pessary every 3 days for 3 months. The primary endpoint was the amelioration of VVA signs after treatment, evaluated by measuring the change from baseline of the Vaginal Health Index (VHI) score. Secondary endpoints included the evaluation of other VVA-related signs and symptoms, safety, and patient-reported and clinician-reported satisfaction and treatment tolerability. The 3-month treatment with Hydeal-D vaginal pessaries showed efficacy for all analyzed endpoints. Improvement exceeded threshold values of VVA diagnosis, sexual dysfunction, and distress, confirming clinically relevant amelioration of VVA symptoms. Changes from baseline conditions confirmed significant improvement of all parameters including the VHI, vaginal pH, patients' perception of VVA symptoms, sexual function, and vaginal maturation. Patients' overall satisfaction was very high after 1 month of treatment and increased further after 3 months. No severe adverse events were reported. Significant amelioration of VVA-related signs indicates that Hydeal-D vaginal pessaries are an effective, safe, and well-tolerated non-hormonal therapeutic option for VVA in postmenopausal women.
本研究旨在评估透明质酸阴道栓剂(Hydeal-D)治疗外阴阴道萎缩(VVA)的疗效和安全性。这是一项针对 40 名绝经后妇女 VVA 局部治疗的前瞻性、多中心临床研究。患者每 3 天使用一次 Hydeal-D 阴道栓剂,持续 3 个月。主要终点是治疗后 VVA 体征的改善,通过测量阴道健康指数(VHI)评分从基线的变化来评估。次要终点包括评估其他与 VVA 相关的体征和症状、安全性以及患者报告和临床医生报告的满意度和治疗耐受性。Hydeal-D 阴道栓剂治疗 3 个月对所有分析终点均有效。改善超过了 VVA 诊断、性功能障碍和痛苦的阈值,证实了 VVA 症状的临床相关改善。与基线相比,所有参数均有显著改善,包括 VHI、阴道 pH 值、患者对 VVA 症状的感知、性功能和阴道成熟度。治疗 1 个月后,患者的整体满意度非常高,3 个月后进一步提高。未报告严重不良事件。VVA 相关体征的显著改善表明,Hydeal-D 阴道栓剂是绝经后妇女 VVA 的一种有效、安全且耐受性良好的非激素治疗选择。