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Effects of Menopausal Hormone Therapy Combined with Pelvic Floor Muscle Training on Pelvic Floor Structure in Patients with Urinary Incontinence:a Randomized Controlled Trial

  

  1. 1.Obstetrics and Gynecology,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China 2.Phase Ⅰ Clinical Trial Laboratory,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China
  • Received:2023-04-03 Revised:2023-05-26
  • Contact: BAI Wenpei,Chief physician;E-mail:baiwp@bjsjth.cn

绝经激素治疗联合盆底肌训练对尿失禁患者盆底结构的影响:一项随机对照试验

  

  1. 1.100038 北京市,首都医科大学附属北京世纪坛医院妇产科 2.100038 北京市,首都医科大学附属北京世纪坛医院药物一期临床试验研究室
  • 通讯作者: 白文佩,主任医师;E-mail:baiwp@bjsjth.cn

Abstract: Background The prevalence of pelvic floor dysfunction in postmenopausal women is progressively increasing,leading to a significant impact on both their physical and mental well-being due to stress urinary incontinence. Objective This study investigates the impact of menopausal hormone therapy(MHT)in conjunction with Kegel exercises on pelvic floor structure and clinical symptoms in individuals experiencing mild to moderate stress urinary incontinence(SUI). Methods A total of 75 patients with menopausal syndrome accompanied by mild to moderate SUI who visited the Menopause Clinic at Beijing Shijitan Hospital in 2022 were selected. They were allocated into the MHT group and the control group in a 2∶1 ratio using a random number table method,and the MHT group was further randomly divided into subgroups receiving Tibolone and estrogen and progestogen therapy(EPT)in a 1∶1 ratio. Both the control group and the MHT group underwent pelvic floor muscle training(PFMT),commonly referred to as Kegel exercises,for 15-30 minutes per session,2-3 times daily,and 2-3 times weekly,over a continuous period of 12 months. The control group received KunTai capsules orally in combination with PFMT,with 4 capsules taken per dose,3 times a day,for 12 months. The MHT group received menopausal hormone therapy in conjunction with PFMT. The EPT subgroups include continuous combined estrogen-progestin therapy(1 mg estradiol valerate + 10 mg dydrogesterone,once daily),continuous sequential estrogen-progestin therapy(femoston 12 courses),and the Tibolone subgroup takes tibolone orally,all of which were administered continuously for 12 months. The study examined serum estradiol(E2)and follicle-stimulating hormone(FSH)levels within and between groups and subgroups before and after treatment. In addition,measurements were obtained for urethral rotation angle(URA),bladder detrusor thickness(BDT),posterior vesicourethral angle(PVUA),levator hiatus area(LHA),urinary incontinence quantification,urinary incontinence score,clinical efficacy,as well as changes in the modified Kupperman Menopausal Index(KMI)score,and the modified oxford staging(MOS). Results Upon completion of the study,7 participants from the MHT group were lost to follow-up(5 in the Tibolone subgroup and 2 in the EPT subgroup),with 3 participants from the control group also lost to follow-up. In the end,a total of 65 participants were included. After 1 year of treatment,there were no statistically significant differences in FSH,E2,and MOS between the MHT group and the control group(P>0.05). After 1 year of treatment,there were no statistically significant differences in PUVA,BDT,and URA between the MHT group and the control group(P>0.05).However,the LHA of the MHT group was significantly lower than that of the control group(P=0.028). After 1 year of treatment,there were no statistically significant differences in PUVA,BDT,URA,and LHA between the EPT and Tibolone subgroups(P>0.05). Statistically significant differences were found in the comparison of clinical efficacy between the control group and the MHT group(P=0.010). Conversely,no statistically significant differences were observed in the comparison of clinical efficacy between the EPT and Tibolone subgroups(P=0.724). After 1 year of treatment,the MHT group showed lower urinary incontinence quantity,urinary incontinence score,and KMI score compared to the control group(P<0.05). Before and after the treatment,there were no statistically significant differences in urinary incontinence quantity,urinary incontinence score,and KMI score between the EPT and Tibolone subgroups(P>0.05). Conclusion The combination of MHT with PFMT yields a positive effect on the pelvic floor structure and markedly alleviates symptoms of urinary incontinence. Nevertheless,there is no significant differences between EPT and Tibolone in the improvement of pelvic floor structure and alleviation of clinical symptoms in patients.

Key words: Stress urinary incontinence, Menopausal hormone therapy, Pelvic floor muscle training, Threedimensional ultrasound of the pelvic floor, Randomized controlled trial

摘要: 背景 绝经后发生盆底功能障碍的患者逐渐增加,压力性尿失禁严重影响女性身心健康。目的 探索绝经期激素治疗(MHT)联合Kegel运动对轻中度压力性尿失禁(SUI)患者盆底结构以及临床症状的影响。方法 选取2022年就诊于北京世纪坛医院更年期门诊的绝经综合征伴轻中度SUI患者75例,按照随机数字表法2∶1分为MHT组和对照组,MHT组再按1∶1随机分为替勃龙亚组和雌孕激素联合治疗(EPT)亚组。对照组和MHT组均给予盆底肌训练(PFMT)治疗,又称Kegel运动,15~30min/次,2~3次/d,2~3次/周,连续12个月。对照组在PFMT基础上口服坤泰胶囊,4粒/次,3次/d,持续治疗12个月。MHT组在PFMT基础上,同时给予绝经激素治疗。EPT亚组包括雌孕激素连续联合(戊酸雌二醇片1mg+地屈孕酮片10mg,1次/d)、雌孕激素连续序贯疗法(芬吗通12个疗程),替勃龙亚组口服替勃龙,连续用药12个月。检查治疗前后各组及亚组间血清雌二醇(E2)和卵泡刺激素(FSH)水平、尿道旋转角(URA)、逼尿肌厚度(BDT)、膀胱尿道后角(PVUA)、肛提肌裂孔面积(LHA)以及尿失禁量、尿失禁评分、临床疗效、改良Kupperman绝经指数(KMI)评分、改良牛津肌力分级的变化。结果 研究结束时,MHT组失访7例(其中替勃龙亚组失访5例,EPT亚组失访2例),对照组失访3例;最终共纳入65例。治疗1年后,MHT组和对照组FSH、E2、MOS分级比较,差异均无统计学意义(P>0.05)。治疗1年后,MHT组和对照组PUVA、BDT、URA比较,差异均无统计学意义(P>0.05);MHT组LHA低于对照组(P=0.028)。治疗1年后,EPT亚组和替勃龙亚组PUVA、BDT、URA、LHA比较,差异均无统计学意义(P>0.05)。对照组和MHT组临床疗效比较,差异有统计学意义(P=0.010);EPT亚组和替勃龙亚组临床疗效比较,差异无统计学意义(P=0.724)。治疗1年后,MHT组尿失禁量、尿失禁评分、KMI评分低于对照组(P<0.05)。治疗前和治疗后,EPT亚组和替勃龙亚组尿失禁量、尿失禁评分、KMI评分比较,差异均无统计学意义(P>0.05)。结论 MHT联合盆底肌锻炼对盆底结构有一定改善作用,并且可以显著缓解尿失禁症状;然而,EPT和替勃龙在改善患者盆底结构和缓解临床症状方面并无明显差别。

关键词: 压力性尿失禁, 绝经激素治疗, 盆底肌训练, 盆底三维超声, 随机对照试验

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