| 论文题名(中文): | 电刺激联合盆底肌训练治疗症状性盆腔器官脱垂的随机对照研究 |
| 姓名: | |
| 论文语种: | chi |
| 学位: | 硕士 |
| 学位类型: | 专业学位 |
| 学位授予单位: | 北京协和医学院 |
| 学校: | 北京协和医学院 |
| 院系: | |
| 专业: | |
| 指导教师姓名: | |
| 论文完成日期: | 2025-05-12 |
| 论文题名(外文): | Effectiveness of electrical stimulation combined with pelvic floor muscle training for symptomatic pelvic organ prolapse: a randomized controlled trial |
| 关键词(中文): | |
| 关键词(外文): | Pelvic organ prolapse electrical stimulation pelvic floor muscle training randomized controlled trial |
| 论文文摘(中文): |
背景和目的:盆底肌训练(pelvic floor muscle training,PFMT)是被推荐用于症状性盆腔器官脱垂(pelvic organ prolapse,POP)的治疗方法。但是,既往研究显示PFMT对脱垂程度的改善率最高为28%。电刺激作为辅助物理治疗方法,可改善盆底肌收缩能力,进而可能改善PFMT的临床治疗效果。然而,电刺激联合PFMT对脱垂的临床疗效缺乏高质量的临床证据支持。本研究拟通过随机对照研究,对电刺激联合PFMT治疗症状性脱垂的近期和远期的临床疗效进行评价。 方法:本研究设计为一项单中心的随机对照研究。在2020年7月至2022年7月期间,纳入110对(220例)产后早期(产后42~60天)诊断为盆腔器官脱垂定量分期(pelvic organ prolapse quantitation,POP-Q)II~III度,同时有伴随症状的足月分娩的初产妇。受试者被随机分到干预组和对照组。干预组接受电刺激联合有监督的PFMT:先进行电刺激治疗(参数:频率30~50赫兹,脉宽300~500微秒)10分钟/次,接着在视觉指导下进行PFMT,持续15分钟,每周2次。此外,完成有监督的PFMT:为物理治疗师一对一指导PFMT,15分钟/次,每周1次。对照组只完成有监督的PFMT,训练方案同干预组,每周3次。干预时间均为12周,受试者在干预开始后第3(治疗结束后7天内)和24个月分别接受2次门诊随访。主要结局指标为POP-Q分期改善率(POP-Q分期改善至少1度),次要结局指标为盆底功能影响问卷简表(pelvic floor impact questionnaire-short form 7,PFIQ-7)评分、盆底肌力和盆底肌电生理值。本研究采用意向性分析方法分析主要和次要结局指标。组间比较采用相应的广义线性模型,对于连续变量(PFIQ-7问卷评分、盆底肌电生理值),我们使用了线性混合模型;对于分类变量(POP-Q分期改善率、盆底肌力),我们使用了Logistic回归模型。以上统计学分析采用5%的显著性水平。 结果:本研究纳入的220名受试者的POP-Q分期均为II度。在随访第24个月,干预组(电刺激联合有监督的PFMT组)和对照组(有监督的PFMT组)的随访率分别为80.0%(88/110)和80.9%(89/110)。两组相比,POP-Q分期改善率在随访第3(50.9% vs. 56.1%,P=0.51)和24个月(55.7% vs. 66.3%,P=0.42)均无统计学差异,敏感性分析结果显示缺失数据不影响两组POP-Q分期改善率的结果。但在随访第24个月两组POP-Q分期改善率分别达到了55.7%(49/88)和66.3%(59/89)。此外,在随访第3个月和24个月,两组的PFIQ-7问卷评分、盆底肌力和盆底肌电生理值的差异无统计学意义,但均比基线时明显改善。 结论:电刺激联合有监督的PFMT与有监督的PFMT相比,在改善II度症状性脱垂女性的短期及长期临床疗效上均无统计学差异。但是,两种治疗方法均可使50%以上的II度症状性脱垂女性获得长达2年的脱垂程度改善。 |
| 论文文摘(外文): |
Background and Objectives: Pelvic floor muscle training (PFMT) is recommended as a therapeutic intervention for symptomatic pelvic organ prolapse (POP). However, prior studies indicate that PFMT achieves a maximum improvement rate of 28% in POP stage. Electrical stimulation, as an adjunctive physical therapy modality, may enhance pelvic floor muscle contractility and potentially improve the clinical efficacy of PFMT. Nevertheless, high-quality clinical evidence supporting the combined use of electrical stimulation and PFMT for POP management remains limited. This randomized controlled trial aims to evaluate the short- and long-term effectiveness of electrical stimulation combined with supervised PFMT in symptomatic POP patients. Methods: This single-center randomized controlled trial enrolled 110 pairs (220 participants) of primiparous women diagnosed with symptomatic pelvic organ prolapse quantitation (POP-Q) stage II~III during the early postpartum period (42~60 days postpartum) between July 2020 and July 2022. Participants were randomized into an intervention group and a control group. The intervention group received electrical stimulation combined with supervised PFMT: electrical stimulation therapy (parameters: frequency 30~50 Hz, pulse width 300~500 μs) for 10 minutes/session, followed by visual feedback-guided PFMT for 15 minutes/session, twice weekly. Additionally, supervised PFMT (one-on-one sessions with a physiotherapist, 15 minutes/session) was administered once weekly. The control group received supervised PFMT alone, three times weekly. Both groups underwent 12 weeks of intervention. Follow-up assessments were conducted at 3 months (within 7 days post-treatment) and 24 months post-intervention. Primary outcomes included POP-Q stage improvement rate (≥1-stage improvement), while secondary outcomes comprised Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) scores, pelvic floor muscle strength, and electromyographic values. Intention-to-treat analysis was applied. Generalized linear models were used for group comparisons: linear mixed models for continuous variables(PFIQ-7 scores, electromyographic values) and logistic regression for categorical variables (POP-Q improvement rate, pelvic floor muscle strength). Statistical significance was set at 0.05. Results: All 220 participants had POP-Q stage II at baseline. At 24-month follow-up, follow-up rates were 80.0% (intervention group) and 80.9% (control group). No statistically significant differences were observed in POP-Q stage improvement rates at 3- month (50.9% vs. 56.1%, P=0.51) or 24-month follow-up (55.7% vs. 66.3%, P=0.42). Sensitivity analysis confirmed that missing data did not influence outcomes. Notably, both groups achieved sustained POP-Q stage improvement rates exceeding 50% at 24-month follow-up. Similarly, no intergroup differences were detected in PFIQ-7 scores, pelvic floor muscle strength, or electromyographic values at 3-month or 24-month follow-up, but all outcomes demonstrated significant improvement from baseline. Conclusion: More than half of mild symptomatic POP can be improved by supervised PFMT. There is no significant difference in the effectiveness between electrical stimulation combined with biofeedback and PFMT for mild symptomatic POP. Compared to supervised PFMT alone, the addition of electrical stimulation did not confer statistically superior short- or long-term clinical efficacy in symptomatic POP-Q stage II patients. However, both therapeutic regimens enabled over 50% of stage II prolapse patients to achieve sustained POP stage improvement for up to 2 years. |
| 开放日期: | 2025-05-30 |