Keegan P E, Atiemo K, Cody J, McClinton S, Pickard R
Sunderland Royal Hospital, Kayll Road, Sunderland, Tyne & Wear, U K, SR4 7TP.
Cochrane Database Syst Rev. 2007 Jul 18(3):CD003881. doi: 10.1002/14651858.CD003881.pub2.
Periurethral or transurethral injection of bulking agents is a surgical procedure most often used for the treatment of stress urinary incontinence a common, troublesome symptom amongst adult women.
To assess the effects of periurethral/transurethral injection therapy in the treatment of urinary incontinence in women.
We searched the Cochrane Incontinence Group Specialised Trials Register (28 February 2007), MEDLINE (January 1996 to March 2007, PREMEDLINE (7 February 2007) and the reference lists of relevant articles.
All randomised or quasi-randomised controlled trials of treatment for urinary incontinence, in which at least one management arm involved periurethral/transurethral injection therapy.
Two reviewers independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently using a standard form and clarification concerning possible unreported data sought directly from the investigators.
We identified twelve trials including 1318 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis. Injection of autologous fat was compared to placebo in a study of 68 women which was terminated early because of safety concerns. No differences in subjective or objective outcome were found in the two groups. No studies were found comparing injection therapy with conservative treatment. Two studies that compared injection with surgical management found significantly better objective outcome in the surgical group. Eight studies compared different agents - all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol and carbon spheres gave improvements equivalent to collagen. Porcine dermal implant gave improvements comparable to silicone at six months. A comparison of periurethral and transurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the periurethral group.
AUTHORS' CONCLUSIONS: Despite five additional trials, this updated review is still an unsatisfactory basis for practice. The trials were small and generally of moderate quality. The only evidence of benefit comes for within-group short-term changes following injection. The finding that placebo saline injection was followed by a similar symptomatic improvement questions the mechanism of any effects. There were no trials in comparison with pelvic floor muscle training -the obvious non-surgical comparator. Greater symptomatic improvement was observed after surgery, although these advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents; one small trial suggests that periurethral injection may carry more risks than transurethral injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side-effects. Pending further evidence, injection therapy may represent a useful option for short-term symptomatic relief amongst selected women with co-morbidity that precludes anaesthesia - two or three injections are likely to be required to achieve a satisfactory result.
尿道周围或经尿道注射填充剂是一种外科手术,最常用于治疗压力性尿失禁,这是成年女性中常见且令人困扰的症状。
评估尿道周围/经尿道注射疗法治疗女性尿失禁的效果。
我们检索了Cochrane尿失禁组专业试验注册库(2007年2月28日)、MEDLINE(1996年1月至2007年3月)、PREMEDLINE(2007年2月7日)以及相关文章的参考文献列表。
所有关于尿失禁治疗的随机或半随机对照试验,其中至少有一个治疗组涉及尿道周围/经尿道注射疗法。
两名评价者使用明确的标准独立评估每项研究的方法学质量。使用标准表格独立进行数据提取,并直接向研究者寻求关于可能未报告数据的澄清。
我们确定了12项试验,包括1318名符合纳入标准的女性。现有的有限数据不适合进行荟萃分析。在一项对68名女性的研究中,将自体脂肪注射与安慰剂进行了比较,该研究因安全问题提前终止。两组在主观或客观结果上均未发现差异。未找到将注射疗法与保守治疗进行比较的研究。两项将注射与手术治疗进行比较的研究发现,手术组的客观结果明显更好。八项研究比较了不同的药物——所有结果的置信区间都很宽。硅胶颗粒、羟基磷灰石钙、乙烯-乙烯醇和碳球的改善效果与胶原蛋白相当。猪真皮植入物在六个月时的改善效果与硅胶相当。对填充剂尿道周围和经尿道给药方法的比较发现结果相似,但尿道周围组的早期并发症发生率更高。
尽管又增加了五项试验,但本次更新的综述仍不是一个令人满意的实践依据。这些试验规模较小,质量一般中等。唯一的益处证据来自注射后组内的短期变化。安慰剂盐水注射后出现类似症状改善的发现对任何效应的机制提出了质疑。没有与盆底肌肉训练(明显的非手术对照)进行比较的试验。手术后观察到有更大的症状改善,尽管这些优势需要与可能更高的风险相权衡。比较替代药物的试验无法得出明确结论;一项小型试验表明,尿道周围注射可能比经尿道注射风险更大。自体脂肪的单一试验提醒我们,尿道周围注射偶尔可能会引起严重的副作用。在有进一步证据之前,注射疗法可能是某些患有合并症而无法进行麻醉的女性短期症状缓解的有用选择——可能需要两到三次注射才能取得满意的效果。