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中华妇幼临床医学杂志(电子版)

Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition) ›› 2026, Vol. 22 ›› Issue (05): 418 -427. doi: 10.3877/cma.j.issn.1673-5250.2026.05.006

Original Article

Efficacy analysis of non-hormonal therapeutic regimens in patients with genitourinary syndrome of menopause

Xiaohui Mei, Weiyuan Xing, Weimin Fan, Duanqing Wu, Junhua Guan, Liwen Zhang, Rujun Chen†()   

  1. Department of Gynecology and Obstetrics, Shanghai Fifth People′s Hospital, Fudan University, Shanghai 200240, China
  • Received:2025-07-03 Revised:2026-08-14 Published:2026-10-01
  • Corresponding author: Rujun Chen
  • Supported by:
    Research Project of Shanghai Minhang District Health Commission(2022MW03)
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Objective

To explore the clinical efficacy of non-hormonal therapy (HT) regimens in patients with genitourinary syndrome of menopause (GSM).

Methods

A total of 150 patients diagnosed with GSM who received treatment at Shanghai Fifth People′s Hospital, Fudan University from January 2023 to December 2024 were enrolled as research subjects. A prospective randomized controlled clinical trial was conducted. Subjects were divided into three groups via the random number table method with distinct therapeutic interventions: study group 1 [n=50, treated with pelvic floor muscle training (PFMT), the non-HT], study group 2 (n=50, treated with vaginal moisturizer, the non-HT), and control group (n=50, treated with topical estrogen application, the HT). All patients received 12 weeks of treatment. Before and after intervention, the vaginal atrophy status was assessed using the Vaginal Health Index Score (VHIS); the severity of GSM symptoms was evaluated by the GSM symptom scale; the incidence of urinary incontinence and its impact on patients′ daily lives were measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF); and the severity of menopause-related symptoms was determined via the Kupperman Index. Intra-group and inter-group comparisons of the four aforementioned scoring indicators before and after intervention among the three groups were performed using the chi-square test, Mann-Whitney U test, Kruskal-Wallis H test and Dunn′s test. This study was approved by the Ethics Committee of Shanghai Fifth People′s Hospital, Fudan University(Approval No. Ethics Review [2022] No. 141). All participants signed written informed consent prior to enrollment.

Results

① There were no significant differences among three groups of GSM patients in general clinical data including age and height etc., as well as the total scores and individual item scores of VHIS, GSM symptom scale, ICIQ-UI SF and Kupperman Index before intervention (P>0.05). ② Intra-group comparisons of VHIS indicators revealed that the vaginal elasticity scores after intervention in study group 1 and the control group were significantly higher than that before intervention; the vaginal secretion volume scores after intervention in study group 1 and study group 2 were significantly higher than that before intervention; the vaginal pH scores after intervention in study group 2 and the control group were significantly higher than that before intervention; the vaginal epithelial integrity score after intervention in control group was significantly higher than that before intervention; the vaginal lubrication score and total VHIS score after intervention in all three groups were significantly higher than those before intervention, respectively; the proportion of patients with vaginal pH>5.0 after intervention in study group 2 and the control group was significantly lower than that before intervention; and all above differences were statistically significant (P<0.05). Inter-group comparisons demonstrated that vaginal elasticity scores after intervention in study group 1 and the control group were significantly higher than that in study group 2, and the total VHIS score after intervention in control group was higher than that in study group 1, and the differences were statistically significant (P<0.05). ③ Intra-group comparisons of GSM symptom scores showed that vaginal dryness scores and total GSM scores after intervention in all three groups were lower than those before intervention; the dyspareunia scores after intervention in study group 2 and the control group were lower than that before intervention; and all the above differences were statistically significant (P<0.05). Inter-group comparisons indicated that the vaginal dryness score after intervention in study group 1 was higher than that in control group; the dysuria score after intervention in study group 2 was higher than that in study group 1 and the control group; the dyspareunia score after intervention in study group 1 was higher than that in study group 2, and the differences were statistically significant (P<0.05). ④ Intra-group comparisons of ICIQ-UI SF showed that the urinary incontinence frequency score after intervention in study group 1 was 1 (0, 1), which was lower than that of 1 (0, 2) before intervention, and the difference was statistically significant (Z=2.24, P=0.017). ⑤ Intra-group comparisons of Kupperman index demonstrated that the proportion of patients with Kupperman index ≥16 after intervention in study group 1 and the control group were lower than that before intervention, respectively; the total Kupperman index scores after intervention in study group 1 and study group 2 were lower than that before intervention, respectively; and all the differences were statistically significant (P<0.05).

Conclusions

PFMT and vaginal moisturizer (non-HT), as well as topical estrogen application (HT), can alleviate genitourinary symptoms in patients with GSM to varying degrees with respective advantages, providing diversified and individualized options for clinical management of GSM.

Key words: Menopause, Female urogenital diseases, Atrophic vaginitis, Exercise therapy, Vaginal creams, foams, and jellies, Therapeutics
表1 本研究3组GSM患者一般临床资料比较
组别 例数 年龄(岁，±s) 身高(cm，±s) 体重(kg，±s) 孕次(次，±s) 产次(次，±s) 已绝经者[例数(%)]
研究组1 50 47.5±5.0 158.1±5.1 55.1±8.0 3.4±1.1 1.8±0.8 15(30.0)
研究组2 50 48.1±4.6 159.3±4.8 56.2±8.4 3.3±1.2 1.6±0.8 22(44.0)
对照组 50 47.1±4.3 158.5±4.5 55.5±8.5 3.1±1.6 1.7±0.9 18(36.0)
统计量   F＝0.29 F＝1.16 F＝0.04 F＝0.75 F＝0.61 χ2＝2.12
P值   0.749 0.317 0.965 0.472 0.545 0.346
表2 本研究3组GSM患者干预前、后阴道萎缩评估指标组内及组间比较
组别 例数 阴道弹性评分[分，M(Q1，Q3)] 阴道分泌物量评分[分，M(Q1，Q3)]
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 2.0(1.0，2.8) 2.0(2.0，3.0) －2.24 0.018 2.0(1.3，3.0) 3.0(2.0，3.0) －1.88 0.044
研究组2 50 2.0(1.0，2.8) 2.0(1.0，2.8) －0.51 0.591 2.0(1.0，3.0) 3.0(2.0，3.8) －2.66 0.005
对照组 50 2.0(1.0，3.0) 3.0(2.0，5.0) －3.84 <0.001 2.0(1.0，3.0) 3.0(2.0，3.0) －1.58 0.097
χ2值   0.59 18.26     0.36 2.32    
P值   0.746 <0.001     0.840 0.313    
组别 例数 阴道pH值评分[分，M(Q1，Q3)] 阴道上皮完整性评分[分，M(Q1，Q3)]
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 2.0(1.0，3.0) 2.0(1.0，3.0) －0.36 0.706 2.0(1.3，3.0) 2.0(2.0，3.0) －0.35 0.712
研究组2 50 2.0(1.0，3.0) 3.0(2.0，4.0) －2.39 0.014 2.0(1.0，3.0) 2.0(2.0，3.0) －1.84 0.052
对照组 50 2.0(1.0，3.0) 2.5(2.0，3.0) －2.24 0.021 2.0(1.0，3.0) 3.0(2.0，3.0) －2.20 0.022
χ2值   0.12 4.88     0.31 5.94    
P值   0.943 0.087     0.857 0.051    
组别 例数 阴道润滑度评分[分，M(Q1，Q3)] VHIS总分[分，M(Q1，Q3)]
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 1.0(1.0，2.0) 2.0(1.0，2.0) －2.26 0.014 10.0(8.0，13.0) 11.0(10.0，13.0) －2.24 0.024
研究组2 50 1.0(1.0，2.0) 2.0(1.0，3.0) －2.11 0.021 10.0(7.0，12.8) 12.0(11.0，15.0) －3.61 <0.001
对照组 50 1.0(1.0，2.0) 2.0(1.0，3.0) －1.93 0.039 10.0(7.0，13.0) 14.0(11.0，15.0) －4.08 <0.001
χ2值   0.51 0.57     0.06 7.69    
P值   0.774 0.753     0.968 0.021    
组别 例数 阴道pH值>5.0者[例数(%)]
干预前 干预后 χ2值 P值
研究组1 50 43(86.0) 39(78.0) 0.61 0.436
研究组2 50 44(88.0) 32(64.0) 6.63 0.010
对照组 50 45(90.0) 30(60.0) 10.45 0.001
χ2值   0.38 4.06    
P值   0.830 0.130    
表3 本研究3组GSM患者干预前、后GSM各项症状评分与总分组内及组间比较[分，M(Q1，Q3)]
组别 例数 阴道干燥评分 阴道刺痛评分
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 2.0(2.0，3.0) 2.0(1.0，2.0) 2.04 0.031 2.0(1.0，3.0) 2.0(1.0，2.0) 1.82 0.057
研究组2 50 2.0(1.0，3.0) 1.0(1.0，2.0) 2.19 0.023 2.0(1.3，3.0) 2.0(1.0，3.0) 1.49 0.119
对照组 50 2.0(1.0，2.0) 1.0(0.3，2.0) 2.73 0.004 2.0(1.0，2.0) 2.0(1.0，2.0) 1.71 0.074
χ2值   3.83 6.35     2.61 1.89    
P值   0.147 0.042     0.271 0.389    
组别 例数 排尿困难评分 性交困难评分
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 2.0(1.0，3.0) 2.0(1.0，3.0) 0.24 0.812 2.0(2.0，3.0) 2.0(1.3，3.0) 0.63 0.504
研究组2 50 2.0(2.0，3.0) 2.0(2.0，3.0) 0.14 0.888 2.0(2.0，3.0) 2.0(0，2.0) 3.52 <0.001
对照组 50 2.0(1.0，2.8) 2.0(1.0，2.0) 1.10 0.249 2.0(1.3，3.0) 2.0(1.0，2.8) 2.33 0.015
χ2值   1.97 6.66     0.12 7.12    
P值   0.374 0.036     0.944 0.028    
组别 例数 GSM症状评分总分
干预前 干预后 χ2值 P值
研究组1 50 8.0(7.3，9.0) 7.0(6.0，8.0) 3.39 0.001
研究组2 50 9.0(7.0，10.0) 7.0(5.0，8.8) 3.63 <0.001
对照组 50 8.0(6.3，9.0) 6.0(5.0，8.0) 3.37 <0.001
χ2值   4.97 0.57    
P值   0.084 0.110    
表4 本研究3组GSM患者干预前、后ICIQ-UI SF各条目评分与总分组内及组间比较[分，M(Q1，Q3)]
组别 例数 尿失禁频率评分 漏尿量评分
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 1.0(0，2.0) 1.0(0，1.0) 2.24 0.017 2.0(0，2.0) 2.0(0，2.0) 0.13 0.883
研究组2 50 1.0(0，2.0) 1.0(0，1.8) 0.20 0.834 2.0(0，2.0) 2.0(0，2.0) －0.19 0.832
对照组 50 1.0(1.0，2.0) 1.0(0，1.0) 1.65 0.077 2.0(2.0，2.0) 2.0(0，2.0) 0.50 0.542
χ2值   1.38 1.19     2.66 0.62    
P值   0.503 0.552     0.265 0.734    
组别 例数 尿失禁对日常生活影响评分 ICIQ-UI SF总分
干预前 干预后 Z值 P值 干预前 干预后 Z值 P值
研究组1 50 2.5(0，6.0) 2.0(0，4.8) 0.56 0.575 6.0(0，9.0) 5.0(0，7.0) 1.11 0.262
研究组2 50 1.0(0，5.0) 1.0(0，5.0) －0.10 0.914 5.0(0，9.0) 5.0(0，9.0) －0.08 0.937
对照组 50 3.0(1.0，5.0) 3.0(1.0，5.0) 0.10 0.925 7.0(4.0，8.8) 6.0(2.5，8.0) 0.67 0.503
χ2值   1.88 1.25     1.58 0.68    
P值   0.391 0.535     0.454 0.712    
表5 本研究3组GSM患者干预前、后Kupperman评分相关指标组内及组间比较
组别 例数 Kupperman评分≥16分者[例数(%)] Kupperman评分[分，M(Q1，Q3)]
干预前 干预后 χ2值 P值 干预前 干预后 Z值 P值
研究组1 50 29(58.0) 17(34.0) 4.90 0.027 17.5(13.3，23.0) 14.5(11.3，17.8) 2.02 0.044
研究组2 50 29(58.0) 24(48.0) 0.64 0.423 18.5(12.0，25.0) 15.0(12.0，22.8) 2.81 0.005
对照组 50 31(62.0) 13(26.0) 10.83 0.001 19.0(13.0，24.8) 12.0(10.3，16.8) 1.66 0.097
χ2值   0.22 5.38     0.23 4.17    
P值   0.895 0.068     0.893 0.125    
表6 本研究GSM患者相关症状、采用HT方案与原理及非HT替代方案总结
GSM症状类别 采用局部HT方案 HT原理 非HT替代方案
阴道健康问题(VHIS相关)：弹性差、分泌物量异常、润滑度低、pH值>5.0 结合雌激素软膏局部治疗 雌激素与阴道上皮细胞雌激素受体结合，促进细胞增殖、角化，增加上皮厚度；调节阴道分泌物量，改善阴道弹性与湿润度；调节阴道微环境，恢复阴道弱酸性状态 ①PFMT：可改善阴道弹性、分泌物量、湿润度，对阴道pH值无显著影响。②阴道保湿剂：可改善分泌物量、湿润度，降低阴道pH值，恢复阴道弱酸性，对阴道弹性无显著影响
GSM核心症状：阴道干燥、性交困难 结合雌激素软膏局部治疗 通过调节阴道上皮组织代谢，增加阴道黏膜湿润度，缓解阴道干燥；改善阴道黏膜弹性，减少性交时黏膜摩擦不适，缓解性交困难 ①PFMT：可改善阴道干燥，对性交困难无显著优势。②阴道保湿剂：可改善阴道干燥，并且对性交困难的改善效果优于PFMT
中、重度绝经相关症状(Kupperman评分≥16分)：潮热、失眠、易激动等 结合雌激素软膏局部治疗 通过调节内分泌相关通路，改善因雌激素水平下降所致中、重度绝经相关症状 ①PFMT：通过改善阴道局部血液循环、调节自主神经功能，减轻中、重度绝经相关症状。②阴道保湿剂：对此类症状无明显改善作用
尿失禁相关问题：尿失禁频率高，对日常生活有影响 无 HT对尿失禁严重程度、漏尿量及对日常生活影响无显著改善作用，无明确有效调节机制 ①PFMT：通过增强盆底肌收缩力、减少膀胱颈活动度，从而降低尿失禁频率。②阴道保湿剂：对此类问题无显著改善作用
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