经闭孔尿道中段悬吊带术与无张力阴道吊带术治疗压力性尿失禁的随机对照试验
Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial.
作者信息
Ross Sue, Robert Magali, Swaby Cheryl, Dederer Lorel, Lier Doug, Tang Selphee, Brasher Penny, Birch Colin, Cenaiko Dave, Mainprize Tom, Murphy Magnus, Carlson Kevin, Baverstock Richard, Jacobs Philip, Williamson Tyler
机构信息
From the Departments of Obstetrics and Gynaecology, Family Medicine, Community Health Sciences, and Department of Surgery (Urology), University of Calgary, Calgary, Alberta, Canada; the Institute of Health Economics, Edmonton, Alberta, Canada; the Department of Statistics, University of British Columbia, Vancouver, British Columbia, Canada; and the Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
出版信息
Obstet Gynecol. 2009 Dec;114(6):1287-1294. doi: 10.1097/AOG.0b013e3181c2a151.
OBJECTIVE
To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively.
METHOD
Women with SUI were randomly allocated to either transobturator tape or TVT procedures and reviewed at 12 months after surgery. The primary outcome was objective evidence of "cure," evaluated by standardized pad test (cure defined as less than 1 g urine leaked). Other outcomes included complications, subjective cure, incontinence-related quality of life, return to usual sexual activity, and satisfaction with surgery. Primary analysis compared the proportion of patients in each group who were cured at 12-month follow-up.
RESULTS
A total of 199 women participated (94 in the transobturator tape group, 105 in the TVT group). Sixty-eight women (81%) in the transobturator tape group were cured, compared with 67 (77%) in the TVT group (relative risk 1.05, 95% confidence interval 0.90-1.23, P=.577). On vaginal examination, the tape was palpable for 68 women (80%) in the transobturator tape group and for 24 (27%) in the TVT group (relative risk 0.22, 95% confidence interval 0.13-0.37, P<.001). More women in the transobturator tape group experienced groin pain during vaginal palpation (13 [15%] in the transobturator tape group and five [6%] in the TVT group, P=.044). Quality of life improved significantly from baseline in both groups (30-point improvement in IIQ-7 score for both groups).
CONCLUSION
At 12 months, the majority of women had minimal leakage and their quality of life had improved significantly, but differences were not observed between groups. The presence of palpable tape, particularly among the transobturator tape group, is concerning; longer follow-up is needed to determine whether this outcome leads to extrusion or resolves over time.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00234754.
LEVEL OF EVIDENCE
I.
目的
比较经闭孔尿道中段无张力悬吊术（TOT）与无张力阴道吊带术（TVT）在术后12个月时治疗压力性尿失禁（SUI）的客观疗效。
方法
将患有SUI的女性随机分配接受TOT或TVT手术，并在术后12个月进行复查。主要结局是通过标准化尿垫试验评估的“治愈”的客观证据（治愈定义为漏尿量少于1克）。其他结局包括并发症、主观治愈、与尿失禁相关的生活质量、恢复正常性活动以及对手术的满意度。初步分析比较了两组中在12个月随访时治愈的患者比例。
结果
共有199名女性参与研究（TOT组94名，TVT组105名）。TOT组有68名女性（81%）治愈，而TVT组为67名（77%）（相对危险度1.05，95%置信区间0.90 - 1.23，P = 0.577）。阴道检查时，TOT组有68名女性（80%）可触及吊带，TVT组为24名（27%）（相对危险度0.22，95%置信区间0.13 - 0.37，P < 0.001）。TOT组更多女性在阴道触诊时出现腹股沟疼痛（TOT组13名[15%]，TVT组5名[6%]，P = 0.044）。两组生活质量均较基线有显著改善（两组IIQ - 7评分均提高30分）。
结论
术后12个月时，大多数女性漏尿极少，生活质量显著改善，但两组间未观察到差异。可触及吊带的情况，尤其是在TOT组，令人担忧；需要更长时间的随访来确定这一结果是否会导致吊带挤出或随时间缓解。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00234754。
证据级别
I级
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