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无张力阴道吊带术(TVT)与经阴道吊带成形术(IVS)治疗压力性尿失禁:一项多中心随机试验。

Tension-free vaginal tape (TVT) and intravaginal slingplasty (IVS) for stress urinary incontinence: a multicenter randomized trial.

作者信息

Meschia Michele, Pifarotti Paola, Bernasconi Francesco, Magatti Fabio, Viganò Riccardo, Bertozzi Rosanna, Barbacini Pietro

机构信息

Department of Obstetrics and Gynecology, Ospedale G. Fornaroli, Magenta, Italy.

出版信息

Am J Obstet Gynecol. 2006 Nov;195(5):1338-42. doi: 10.1016/j.ajog.2006.03.067. Epub 2006 Jun 12.

Abstract

OBJECTIVE

This study was undertaken to compare the efficacy and morbidity of 2 minimally invasive procedures for stress urinary incontinence.

STUDY DESIGN

This was a prospective randomized multicenter trial; 190 women with primary urodynamic stress incontinence were randomly assigned to tension-free vaginal tape (TVT) (n = 95) or intravaginal slingplasty (IVS) (n = 95). The primary and secondary outcome measures were rates of success and complications. SPSS software was used for data analysis.

RESULTS

At 2 years 92 and 87 patients were available in the TVT and IVS group for outcomes analysis. Subjectively, 80 (87%) and 68 (78%) women were cured, respectively. Objectively, a 1-hour pad test was negative in 78 (85%) and 63 (72%) patients. Eight of the patients assigned to IVS (9%) had vaginal erosion/infection, compared with none in the TVT group (P < .01).

CONCLUSION

Both procedures were effective for stress incontinence, but 9% of women treated with the IVS required removal of the tape for erosions.

摘要

目的

本研究旨在比较两种治疗压力性尿失禁的微创手术的疗效和发病率。

研究设计

这是一项前瞻性随机多中心试验;190例原发性尿动力学压力性尿失禁女性被随机分为无张力阴道吊带术(TVT)组(n = 95)或阴道内吊带成形术(IVS)组(n = 95)。主要和次要结局指标分别为成功率和并发症发生率。采用SPSS软件进行数据分析。

结果

2年后,TVT组和IVS组分别有92例和87例患者可进行结局分析。主观上,分别有80例(87%)和68例(78%)女性治愈。客观上,78例(85%)和63例(72%)患者的1小时垫试验结果为阴性。IVS组有8例(9%)患者发生阴道糜烂/感染,而TVT组无1例发生(P <.01)。

结论

两种手术治疗压力性尿失禁均有效,但接受IVS治疗的女性中有9%因糜烂需要取出吊带。

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