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经闭孔无张力阴道吊带术治疗混合性尿失禁的疗效评估:一项随机对照临床试验的 3 年随访结果。

Evaluation of transobturator tension-free vaginal tapes in the surgical management of mixed urinary incontinence: 3-year outcomes of a randomized controlled trial.

机构信息

University of Aberdeen, Aberdeen, United Kingdom.

University of Aberdeen, Aberdeen, United Kingdom.

出版信息

J Urol. 2014 Jan;191(1):114-9. doi: 10.1016/j.juro.2013.07.035. Epub 2013 Jul 24.

DOI:10.1016/j.juro.2013.07.035
PMID:23892190
Abstract

PURPOSE

We evaluate the clinical effectiveness of transobturator tension-free vaginal tape procedures in the surgical management of mixed urinary incontinence in women at 3-year followup.

MATERIALS AND METHODS

In this secondary analysis of a prospective, single-blind, randomized controlled trial 83 of 341 women (24%) with mixed urinary incontinence were randomized to undergo an outside-in (Aris® transobturator sling system 42) or inside-out (TVT™-O 41) transobturator tension-free vaginal tape procedure. Patients were contacted by postal questionnaire at a minimum of 3 years postoperatively. The primary outcome was the patient reported success rate, defined as very much improved/much improved on the PGI-I (Patient Global Impression of Improvement). Secondary outcomes included improvement in quality of life, impact on preoperative urgency/urgency incontinence and repeat surgical treatment for stress urinary incontinence. Outcomes at 3 years were compared between groups (outside-in vs inside-out) and to 1-year outcomes. Analysis was performed using SPSS® version 20 with significance levels set at p = 0.05.

RESULTS

A total of 66 women with mixed urinary incontinence completed the 3-year followup (outside-in 35 vs inside-out 31). In each group 2 women underwent further continence surgery. The patient reported success rate was 73.8% with no significant differences between the groups (OR 1.035, 95% CI 0.342-3.134, p = 0.951). Overall 34 (50.1%) and 26 women (56.5%) reported cure of preoperative urgency and urgency incontinence, respectively, and 52 women (86.7%) had a clinically significant improvement in quality of life (18 points or more in total KHQ [King's Health Questionnaire] score) compared to baseline.

CONCLUSIONS

Transobturator tape procedures are associated with a good (73.8%) patient reported success rate at a minimum of 3 years of followup in the surgical management of mixed urinary incontinence in women with predominant stress urinary incontinence symptoms. Nearly half of the women reported cure of urgency/urgency incontinence.

摘要

目的

我们在 3 年随访中评估经闭孔无张力阴道吊带术治疗女性混合性尿失禁的临床疗效。

材料和方法

在这项前瞻性、单盲、随机对照试验的二次分析中,341 例混合性尿失禁女性中有 83 例(24%)被随机分为经闭孔外侧(Aris® 吊带系统 42 例)或经闭孔内侧(TVT™-O 41 例)经闭孔无张力阴道吊带术。患者在术后至少 3 年通过邮寄问卷进行联系。主要结局是患者报告的成功率,定义为 PG-I(患者总体改善印象)非常改善/明显改善。次要结局包括生活质量的改善、对术前急迫/急迫性尿失禁的影响和再次治疗压力性尿失禁的手术治疗。将 3 年时的结局与组间(经闭孔外侧与经闭孔内侧)和 1 年时的结局进行比较。使用 SPSS® 版本 20 进行分析,显著性水平设为 p = 0.05。

结果

共有 66 例混合性尿失禁女性完成了 3 年随访(经闭孔外侧 35 例,经闭孔内侧 31 例)。每组各有 2 例患者接受了进一步的控尿手术。患者报告的成功率为 73.8%,两组间无显著差异(OR 1.035,95%CI 0.342-3.134,p = 0.951)。总体上,34 例(50.1%)和 26 例(56.5%)女性报告术前急迫和急迫性尿失禁得到治愈,52 例(86.7%)女性生活质量有显著改善(总 KHQ[King's Health Questionnaire]评分增加 18 分或更多)与基线相比。

结论

在女性压力性尿失禁症状为主的混合性尿失禁的手术治疗中,经闭孔吊带术在至少 3 年的随访中与良好的(73.8%)患者报告成功率相关。近一半的女性报告急迫/急迫性尿失禁得到治愈。

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