Black N A, Downs S H
Department of Public Health and Policy, London School of Hygiene & Tropical Medicine, UK.
Br J Urol. 1996 Oct;78(4):497-510. doi: 10.1046/j.1464-410x.1996.01422.x.
To determine the methodological quality of studies evaluating surgery for stress incontinence, the effectiveness of different procedures and the frequency of complications associated with each procedure.
Eleven randomized controlled trials, 20 non-randomized trials/prospective cohort studies and 45 retrospective cohort studies were reviewed systematically.
The methodological quality of the 31 prospective studies was generally poor. The considerable variation in inclusion criteria, surgical management and assessment of outcome precluded any statistical meta-analysis. Evidence as to the effectiveness of surgery for stress incontinence is weak; therefore, any conclusions are speculative. It appears that colposuspension may be more effective and the effect more long-lasting than that following anterior colporrhaphy and needle suspension. There is little information on the value of sling procedures. Comparisons of different ways of performing each procedure show no significant differences in outcome but this may reflect the methodological weaknesses of the studies. Valid and reliable data on the frequency of complications following surgery are lacking so the safety of the procedures is unclear. Repeat operations to correct stress incontinence are less successful than first procedures but this finding may be subject to confounding.
There is an urgent need for some large, rigorous, prospective studies of high quality. Until such studies have been completed, recommendations as to the best clinical practice cannot be based on scientific evidence. Studies need to define cases according to widely accepted criteria, including standard measures of the severity of stress incontinence, and surgical terminology for the procedures performed needs to be standardized and outcomes need to be clearly defined, valid and reliable, not confined to short-term assessment and include patients' views along with the surgeon's assessments.
确定评估压力性尿失禁手术的研究方法学质量、不同手术方法的有效性以及每种手术相关并发症的发生率。
系统回顾了11项随机对照试验、20项非随机试验/前瞻性队列研究和45项回顾性队列研究。
31项前瞻性研究的方法学质量总体较差。纳入标准、手术管理和结局评估的显著差异使得无法进行任何统计学荟萃分析。关于压力性尿失禁手术有效性的证据不足；因此，任何结论都是推测性的。似乎膀胱颈悬吊术可能比前壁修补术和针式悬吊术更有效且效果更持久。关于吊带手术价值的信息很少。每种手术不同实施方式的比较显示结局无显著差异，但这可能反映了研究的方法学缺陷。缺乏关于手术后并发症发生率的有效和可靠数据，因此手术的安全性尚不清楚。纠正压力性尿失禁的再次手术不如首次手术成功，但这一发现可能存在混杂因素。
迫切需要一些大规模、严谨、高质量的前瞻性研究。在完成此类研究之前，关于最佳临床实践的建议无法基于科学证据。研究需要根据广泛接受的标准定义病例，包括压力性尿失禁严重程度的标准测量方法，所实施手术的术语需要标准化，结局需要明确界定、有效且可靠，不限于短期评估，并且要包括患者的观点以及外科医生的评估。
