Sheffield Teaching Hospital NHS Foundation Trust, Department of Obstetrics and Gynaecology, Sheffield, United Kingdom.
Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):1-10. doi: 10.1016/j.ejogrb.2012.01.004. Epub 2012 Feb 13.
To directly compare the current evidence for the efficacy, complications, quality of life and cost to health services of both transobturator tension free vaginal tape procedures - "inside-out" versus "outside-in" - in the surgical treatment of female stress urinary incontinence.
A prospective peer-reviewed protocol was prepared a priori, and a systematic search of relevant databases from 1966 to January 2011 was performed. Meta-analyses of five randomised trials and three cohort studies were performed separately in accordance with PRISMA and MOOSE, respectively.
There was no significant difference in patient-reported cure/improvement (OR 1.25, 95%CI 0.78, 1.99; p=0.35) nor in objective cure/improvement (OR 1.66, 95%CI 0.8, 3.43, p=0.17) between the two groups at 12-month follow-up. Vaginal angle injuries were significantly higher with the outside-in route (OR 0.14, 95%CI 0.05, 0.41, p=0.0003). Groin/thigh pain and de-novo urgency were non-significantly higher with the inside-out route (OR 1.42, 95%CI 0.94, 2.13, p=0.10 and OR 1.46, 95%CI 0.63, 3.36, p=0.38, respectively). There was no significant difference in postoperative quality of life scores between the two groups (WMD -1.65; 95% CI -5.76, 2.46, p=0.43). None of the trials reported a "health-cost" analysis. Meta-analysis of cohort studies confirmed similar results.
This is the first reported direct meta-analysis comparing both routes of transobturator tapes. It showed no evidence of significant differences in the efficacy and impact on women's quality of life between "inside-out" and "outside-in" transobturator tapes up to one-year follow-up. The "inside-out" route was associated with significantly fewer vaginal angle injuries but with trends towards higher risk of postoperative groin pain. Long-term follow-up of adequately powered RCTs is required to assess if these results pertain.
直接比较经闭孔无张力阴道吊带术(“内进路”与“外进路”)治疗女性压力性尿失禁的疗效、并发症、生活质量和对卫生服务的成本,目前这两种术式的相关证据。
预先准备了前瞻性同行评审方案,并对从 1966 年到 2011 年 1 月的相关数据库进行了系统检索。分别根据 PRISMA 和 MOOSE 进行了 5 项随机试验和 3 项队列研究的荟萃分析。
在 12 个月的随访中,两组患者报告的治愈率/改善率(OR 1.25,95%CI 0.78,1.99;p=0.35)和客观治愈率/改善率(OR 1.66,95%CI 0.8,3.43,p=0.17)无显著差异。阴道角度损伤在外进路组显著更高(OR 0.14,95%CI 0.05,0.41,p=0.0003)。内进路组腹股沟/大腿疼痛和新发尿急的发生率略高(OR 1.42,95%CI 0.94,2.13,p=0.10 和 OR 1.46,95%CI 0.63,3.36,p=0.38)。两组术后生活质量评分无显著差异(WMD -1.65;95%CI -5.76,2.46,p=0.43)。没有试验报告“健康成本”分析。队列研究的荟萃分析证实了类似的结果。
这是首次报道比较经闭孔无张力阴道吊带术两种入路的直接荟萃分析。它表明,在 1 年随访期间,“内进路”与“外进路”经闭孔无张力阴道吊带术在疗效和对女性生活质量的影响方面没有显著差异。“内进路”与阴道角度损伤发生率显著降低相关,但与术后腹股沟疼痛风险增加有关。需要进行长期随访的、充分有力的 RCT 来评估这些结果是否适用。