Efficacy of intradermal hyaluronic acid plus polynucleotides in vulvovaginal atrophy: a pilot study

Abstract

Objective

This study aimed to evaluate the safety and efficacy of vulvovaginal intradermal injections of polynucleotides (PN) combined with hyaluronic acid (HA) in postmenopausal women affected by vulvovaginal atrophy (VVA).

Materials and methods

Postmenopausal women affected by VVA were treated with vulvar and vaginal intradermal injections of one prefilled syringe of 2 ml PN/HA every 2 weeks for four sessions. Patients were evaluated at T0 (baseline), T1 (after session 4) and T2 (1 month after session 4). Evaluation of the treatment was assessed by three international validated questionnaires: Vaginal Health Index (VHI), Vulvar Health Index (VuHI) and Female Sexual Function Index (FSFI). The Wilcoxon matched-paired signed-rank test was used to compare the differences in VHI, VuHI, FSFI and FSFI domains within the groups. Statistical significance was set at p < 0.05.

Results

Fifty patients were included in the study (mean age 59.9 ± 7.6 years). Overall, the VHI, VuHI and FSFI reported statistically significant differences between baseline and T1 (p < 0.001) and between baseline and T2 (p < 0.001). All FSFI domains registered a statistically significant increase between baseline and T2 (p < 0.001). No complications or side effects were observed.

Conclusions

Vulvovaginal intradermal injection of PN/HA is a safe, effective treatment, is not expensive and is a reproducible procedure in postmenopausal women with VVA.

摘要

目的：本研究旨在评估外阴阴道皮内注射多核苷酸（PN）联合透明质酸（HA）治疗外阴阴道萎缩（VVA）的绝经后妇女的安全性和有效性。

材料和方法：每两周对患有VVA的绝经后妇女进行外阴和阴道皮内注射1个2ml PN/HA 预装注射器, 共 4 个疗程。在 T0（基线）、T1（第4个疗程后）和 T2（第4个疗程后1个月）对患者进行评估。通过三个国际验证问卷评估治疗评估：阴道健康指数 (VHI)、外阴健康指数 (VuHI) 和女性性功能指数 (FSFI)。 Wilcoxon 配对符号秩检验用于比较组内VHI、VuHI、FSFI和FSFI域的差异。设定为p<0.05认为有统计学意义。

结果：50名患者被纳入研究（平均年龄 59.9±7.6 岁）。总体而言, VHI、VuHI 和 FSFI在基线和 T1 (p<0.001) 以及基线和 T2 (p<0.001) 之间的差异具有统计学意义。所有FSFI域在基线和 T2之间都有统计学意义的增加（p<0.001）。未观察到并发症或副作用。

结论：外阴阴道皮内注射PN/HA 是一种安全、有效的治疗方法, 价格不贵, 并且是绝经后 VVA 妇女可重复的手术。

Keywords:

• Vulvovaginal atrophy
• menopause
• vulvar biostimulation
• hyaluronic acid
• polynucleotides

Potential conflict of interest

All authors receive personal fees from UNIDERM s.r.l.

Source of funding

Nil.