第一临床医学院知识库

背景 盆底功能障碍性疾病是影响女性健康的一个全球性医学和卫生问题，其中最常见的尿失禁已成为世界5大疾病之一，严重影响患者生活质量，因此有人称其为“社交癌”。盆底肌训练（pelvic floor muscle training，PFMT）对盆底功能障碍性疾病的疗效已被大量高质量研究所证实且在很多临床实践指南中作为保守治疗的一线治疗方式强烈推荐。然而，盆底肌训练对有些疾病的疗效仍不清楚，患者对盆底肌训练的认知度和训练依从性普遍不高，严重制约着证据的临床转化。

目的和方法 1.采用文献计量学方法调查盆底肌训练的研究现状，了解其发展现状和趋势。2.采用系统评价再评价的方法综合评价盆底肌训练的有效性和适用人群，全面、清晰、明确的展现盆底肌训练的证据全貌。3.基于健康信念理论和行为分阶段转变理论的整合模型，结合盆底肌训练的本质和影响因素研制初产妇盆底肌训练认知和行为意向调查问卷，采用问卷调查法了解初产妇盆底肌训练的认知情况和行为阶段，继而根据证据、问卷调查结果、医疗机构现状等探索提高初产妇训练依从性的多组分干预策略。4.利用随机对照试验，验证多组分干预策略对提高初产妇盆底肌训练依从性和盆底肌功能的疗效。

结果 1.纳入盆底肌训练相关文献605篇。文献发表数量呈逐年递增趋势；随机对照试验分别占外文文献和英文文献的55.65%和36.25%；76.54%的外文文献发表在被SCI收录的期刊上；研究最多的是美国、英国、挪威和巴西；高产作者Bo k发表论文22篇；热点研究领域为女性尿失禁、男性尿失禁及盆腔器官脱垂。2.共纳入盆底肌训练相关系统评价37篇，22个研究针对尿失禁的预防和治疗，6个针对前列腺癌根治术后尿失禁的预防和治疗，4个针对盆底器官脱垂的治疗，2个针对性功能障碍治疗，1个针对分娩结果，1个针对所有盆底功能障碍性疾病。37个纳入系统评价的AMSTAR（A Measurement Tool to Assess the Methodological Quality of Systematic Reviews，AMSTAR）总分为2～11分，30（81.1%）个为高质量，6（16.2%）个为中等质量，1（2.7%）个为低质量。PFMT对成年女性轻、中度尿失禁疗效显著，对年轻患者和压力性尿失禁患者效果优于老年患者和其他类型尿失禁患者；可明显改善轻、中度盆腔器官脱垂患者的症状，减轻脱垂的严重程度，提高患者生活质量，但是对于需手术治疗的重度脱垂患者，手术联合围手术期PFMT并不优于单独手术治疗；前列腺癌术后进行恰当的PFMT对术后尿失禁的治疗有效；PFMT可以改善性功能；对大便失禁的疗效证据不充分。仅有2例报道不良反应为盆腔痛。3.研制的初产妇盆底肌训练认知和行为意向调查问卷，共39个条目。共发放问卷355份，收回351份，收回率98.87%，有效问卷332份，研究结果表明产妇普遍缺乏盆底功能障碍性疾病及盆底肌训练的相关知识。但是，产妇进行盆底肌训练的意愿较强烈。超过75.9%的产妇在产后6个月打算进行盆底肌锻炼或已经开始进行锻炼。然而，绝大多数处于盆底肌训练行为阶段的初期。未考虑进行盆底肌训练与相关知识缺乏、个人收入较低、剖宫产和行动线索较少有关；正在考虑在未来6个月内如何锻炼与文化程度相关。正在采取行动锻炼与危机感有关；已经感受到盆底肌锻炼的一些益处并维持锻炼以增强效果与产妇的自我效能有关。4.产后42天，两组产妇对盆底肌训练方法的掌握比例均有所提高，且多组分干预组对盆底肌训练方法的掌握（97.0% vs 80.0%, P=0.002）和训练依从性（78.8% vs 46.2%, P<0.05）优于对照组。多组分干预组和对照组肌力达到3级及以上的比例分别为74.2%和44.6%，两组差异有统计学意义。4个电生理指标分别比较，差异均无统计学意义（P>0.05）。

结论 1.盆底肌训练应用范围广泛，文献数量总体呈上升趋势，但其研究和应用存在地区差异，对很多疾病的有效性仍缺乏充分的证据支持，需进一步开展高质量的研究。2.足够强度的盆底肌训练对于盆底功能障碍性疾病有效。按疾病种类分，尤其对轻、中度尿失禁和盆腔器官脱垂效果更佳，对前列腺癌根治术后尿失禁和性功能障碍显示有效，对大便失禁的疗效证据不充分。按研究对象分，对年轻患者和围产期患者疗效最佳，对老年患者效果次之。同时，盆底肌训练具有简单易行，无创、无严重不良反应，成本效益好的优点。3.产妇对盆底功能障碍性疾病和盆底肌训练的知识认知度较低，但是训练的意愿相对较高。不同的盆底肌训练行为阶段受不同因素影响。医疗服务者应结合多学科的干预策略，对孕产妇进行干预前, 首先应评估干预对象所处的行为阶段及需求，然后采取阶段匹配的措施帮助产妇逐步进入下一训练阶段，提高产妇盆底肌训练的长期依从性。4.基于循证医学证据和健康行为理论的多组分干预策略不仅可以提高初产妇盆底肌肌力，改善产妇盆底肌功能，而且可以提高初产妇盆底肌训练的认知度和训练依从性。

Background Pelvic floor disorder (PFD) is a global medical and health problems, which leads to greatly lower on women's health. Urinary incontinence (UI), the most common type of PFD, has become one of the world's five major diseases, therefore it has been called as "social cancer" due to its greatly affect on patients’ quality of life. The curative effect of pelvic floor muscle training (PFMT) for PFD has been confirmed by a large number of high quality studies. Moreover, PFMT was recommended as first-line treatment way of conservative treatment in many  practice guidelines. However, the effectiveness of PFMT for some types of PFD is unclear. Besides, patients’ acknowledge about PFMT and training adherence are not high generally, which severely restricts the translation from high quality evidence of PFMT to clinical practice.

Objectives and Methods 1. To survey the current situation and understand the development trends of PFMT taking the method of documentation metrology. 2. To evaluate the effectiveness of PFMT and applicable people by the method of overviews of reviews, so that we can show evidence of PFMT more comprehensive, more clear. 3. Based on the integration of health belief model with the transtheoretical model and stages of change, incorporating the essence of PFMT and influencing factors, we developed a primipara PFMT cognitive and behavioral intention questionnaire. We investigated the current state of primipara’s PFMT cognition and exercising stages using the questionnaire. Then according to the evidence, the results of the survey and the present status of medical institutions we developed a multicomponent intervention in the taking up of PFMT among woman who has been delivered of a child for the first time. 4. To assess the effect of a multicomponent intervention for primipara using randomized controlled trial.

Results 1. A total of 605 PFMT literatures were included. The number of published literature has been increasing year by year. The percent of randomized controlled trial of foreign datebase literatures and Chinese datebase literatures are 55.65% and 36.25%, respectively. 76.5% PFMT papers were published on journals as SCI. There are more literatures from USA, UK, Norway and Brazil. It is up to twenty two articles published by Bo k who is one of the prolific authors on PFMT. The hot research fields are urinary incontinence in male and female, pelvic organ prolapse. 2. We identified 37 eligible overviews of reviews related to PFMT, of which 22 for UI, 6 for prevention and treatment UI among patients undergoing radical prostatectomy, 4 for pelvic organ prolapse (POP), 2 for sexual dysfunction, 1 for birth outcomes, 1 for all types of PFD, 1 for fecal incontinence. The total AMSTAR（A Measurement Tool to Assess the Methodological Quality of Systematic Reviews，AMSTAR）score of included systematic reviews ranged form 2～11, 30（81.1%）were rated high methodological quality, 6（16.2%）were rated medium methodological quality, 1（2.7%）was rated low methodological quality. PFMT is very effective among adult women with mild to moderate UI, and is more effective for young women and SUI. Moreover, PFMT can decrease the symptom and prolapse severity for patient with POP, but PFMT with surgery are not better than surgery alone for patient with severe POP. Post operation PFMT benefits to patients undergoing radical prostatectomy. PFMT is also good for patients with sexual dysfunction but not to patients with fecal incontinence. Only 2 cases of PFMT adverse events are reported. 3. A questionnaire containing 39 items has been developed, which was used to survey the current state of primipara’s PFMT cognition and exercising stages. We have sent 355 questionnaires totally, and collected 351 (98.87%), of which 332 were effective. The results suggested that although primipara generally lack the knowledge of PFD and PFMT, they have strong will to do PFMT. More than 75.9% of primipara intended to do PFMT in 6 months after delivery. However, the majority of them were on the early stages of PFMT. Not planning to do PFMT had relationship with lack of knoweledge, low income, undergoing cesarean delivery and less cues to action. Considering how to exercise in the next 6 months related to level of education. Taking action to do PFMT was related to the sense of crisis . Already felt some benefits of PFMT and maintained exercising to enhance effects were associated with high self-efficacy. 4. After delivering for 42 days, both groups of lying-in women have greatly improved in learning the PFMT methods and training adherence, multicomponent intervention group was superior to control group in learning the PFMT methods（97.0% vs 80.0%, P=0.002）and training adherence （78.8% vs 46.2%, P<0.05). The percent of pelvic floor musscle strength reached level 3 or above were 74.2% and 44.6% respectively, there were statistical differences between the the two groups. While there were no significant statistical differences between the two groups refering to four electrophysiological parameters respectively.

Conclusions 1. The applicable fields of PFMT are extensive and the number of literatures for PFMT is increasing generally, however, there are differences in country or region in which PFMT was focused on. In addition, there are not robust evidences on the effectiveness of PFMT in many areas. Thus, further studies are needed which should be high quality in the methodology. 2. Enough intensities of PFMT for PFD is effective. According to disease type, PFMT has more positive effect for mild and moderate urinary incontinence and pelvic organ prolapse. People undergoing radical prostatectomy as well as people with sexual dysfunction can get benifits from PFMT. There was no suffient evidence to support the management of people with fecal incontinence using PFMT. According to research patients, PFMT are with better effect for the younger and perinatal women than the older. Meanwhile, PFMT is a simple rehabilitation method , without trauma , adverse effect and cost. 3. Although primipara generally lack the knowledge of PFD and PFMT, they have strong will to do PFMT. Different stages of PFMT affected by different factors. Therefore, health care proiders should combine multidisciplinary intervention strategies, evaluting the stage of PFMT and determining the needs of the object firstly, then taking  personalized measures matching stage to help women gradually into the next exercising phase, improving the long-term exercising adherence of maternal. 4. Based on the evidence of evidence-based medicine and the theory of health behavior, multicomponent intervention strategy not only can improve pelvic floor muscle strength and function , but also can improve the PFMT awareness and training adherence of primipara.