目的:合成材料已用于手术治疗压力性尿失禁(SUI)和盆腔器官脱垂(POP)。在过去的25年里,这些材料主要由聚丙烯(PP)组成,而最近使用聚偏二氟乙烯(PVDF)由于其特性而引起越来越多的兴趣。本研究旨在通过综合现有相关文献的数据,比较使用PVDF和PP材料进行SUI/POP手术后的结果。
方法:本系统综述和荟萃分析包括临床试验,病例对照研究,或以英语编写的队列研究。搜索策略包括电子数据库MEDLINE,EMBASE,还有Cochrane,和灰色文学(IUGA大会,EUGA,AUGS,FIGO).所有研究都必须提供数字数据或优势比(OR),与其他使用材料的结果相比,在PVDF手术中开发特定结果。没有种族或民族的限制,也不是按时间顺序的限制。排除标准是包括认知障碍患者的研究,痴呆症,中风,或者中枢神经系统创伤.所有研究都由两名评审员筛选,最初按标题和摘要,之后是全文。分歧是通过双方同意解决的。对所有研究的质量和偏倚风险进行评估。使用在MicrosoftExcel电子表格中公式化的数据提取表格来提取数据。我们的结果分为仅针对SUI患者的研究,仅针对POP患者的研究,以及在SUI和POP手术中表达的变量的累积分析。主要结果是术后复发率,网孔侵蚀,与PP相比,PVDF术后疼痛。次要结果是术后性不满,总体满意率,血肿,尿路感染,从头急迫性尿失禁,和再手术率。
结果:SUI/POP术后复发率无差异,网孔侵蚀,PVDF与PP术后疼痛比较。与PP组相比,使用PVDF胶带进行SUI手术后的患者从头尿急的发生率在统计学上显着降低[OR=0.38(0.18,0.88),p=0.01;与PP组相比,使用PVDF材料进行POP手术后的患者从头性功能障碍的发生率显着降低[OR=0.12(0.03,0.46),p=0.002]。
结论:这项研究提供了证据,表明在SUI/POP手术中使用PVDF可能是PP的有效替代方法。然而,由于现有数据的总体质量较低,我们的结果受到不确定性的限制。进一步的研究和验证将有助于更好的手术技术。
OBJECTIVE: Synthetic materials have been used for the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). During the last 25 years, these materials were composed mostly of polypropylene (PP), whereas recently the use of polyvinylidene difluoride (PVDF) is of increasing interest due to its characteristics. This study aimed to compare the results after SUI/POP surgery using PVDF versus PP materials by synthesizing the data of relevant existing literature.
METHODS: This systematic
review and meta-analysis included clinical trials, case-control studies, or cohort studies written in the English language. The search strategy included the electronic databases MEDLINE, EMBASE, and Cochrane, and grey literature (congresses IUGA, EUGA, AUGS, FIGO). All studies have to provide numeric data or odds ratios (OR) of developing a specific outcome in surgeries with PVDF compared with outcomes of other used materials. No restrictions of race or ethnicity were applied, nor chronological restrictions. Exclusion criteria were studies that included patients with cognitive impairment, dementia, stroke, or central nervous system trauma. All studies were screened by two reviewers, initially by title and abstract, and afterward by full text. Disagreements were resolved through mutual consent. All studies were assessed for their quality and bias risk. Data were extracted using a data extraction form formulated in a Microsoft Excel spreadsheet. Our results were divided into studies dealing only with SUI patients, studies dealing only with POP patients, and cumulative analysis of variables expressed in both SUI and POP surgery. The primary outcomes were the rates of post-operative recurrence, mesh erosion, and postoperative pain after surgery with PVDF compared to PP. The secondary outcomes were post-operative sexual dissatisfaction, overall satisfaction rates, hematoma, urinary tract infection, de novo urge incontinence, and reoperation rate.
RESULTS: No differences in the post-operative rates of SUI/POP recurrence, mesh erosion, and pain were found after surgery with PVDF vs surgery with PP. Patients after SUI surgery with PVDF tapes had statistically significant lower rates of de-novo urgency compared to the PP group [OR = 0.38 (0.18, 0.88), p = 0.01]; patients after POP surgery with PVDF materials had statistically significant lower rates of de-novo sexual dysfunction compared to the PP group [OR = 0.12 (0.03, 0.46), p = 0.002].
CONCLUSIONS: This study provided evidence that the use of PVDF in SUI/POP surgeries could be a valid alternative to PP. However our results are limited by uncertainty due to the overall low quality of the existent data. Further research and validation would contribute to better surgical techniques.