Effectiveness of hyaluronate-based pessaries in the treatment of vulvovaginal atrophy in postmenopausal women

Abstract

Objectives: This study aimed to assess the efficacy and safety of hyaluronic acid-based vaginal pessaries (Hydeal-D) in the treatment of vulvovaginal atrophy (VVA).

Study design: 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.

Main outcome measures: 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.

Results: 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.

Conclusions: 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.

摘要

目的: 本研究旨在评估透明质酸阴道栓(Hydeal-D)治疗外阴阴道萎缩（VVA）的疗效和安全性。

研究设计: 本研究对40名进行VVA局部治疗的绝经后妇女进行了前瞻性、多中心的临床研究。患者每三天应用一次Hydeal-D , 共用3个月。

主要结局测量：主要终点是治疗后VVA体征的改善, 通过测量与基线水平相比的阴道健康指数(VHI)评分变化进行评估。次要终点包括评估其他VVA相关体征和症状、安全性、患者报告和临床医生报告的满意度和治疗耐受性。

结果: 应用透明质酸阴道栓治疗三个月对所有分析的终点指标都有效。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。相比于基线状况的改变证实了所有指标的显著改善, 包括VHI、阴道pH值、患者对VVA症状的感知、性功能和阴道成熟指数。治疗1个月后患者总体满意度很高, 且3个月后进一步提高。没有严重不良事件的报道。

结论：VVA相关体征的显著改善表明透明质酸阴道栓是治疗绝经后妇女VVA的一种有效、安全、耐受性良好的非激素治疗方案。

Keywords:

• Vulvovaginal atrophy
• hyaluronic acid
• vaginal pessaries
• menopause
• vaginal dryness

Potential conflict of interest

No potential conflict of interest was reported by the authors.

Source of funding

This study was funded by Fidia Farmaceutici SpA.