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前瞻性多中心研究:可调式单切口迷你吊带(Ajust(®))在女性压力性尿失禁治疗中的应用:1 年随访研究。

Prospective multi-centre study of adjustable single-incision mini-sling (Ajust(®) ) in the management of stress urinary incontinence in women: 1-year follow-up study.

机构信息

Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland.

出版信息

BJU Int. 2012 Mar;109(6):880-6. doi: 10.1111/j.1464-410X.2011.10471.x. Epub 2011 Aug 26.

DOI:10.1111/j.1464-410X.2011.10471.x
PMID:21883844
Abstract

OBJECTIVES

To determine whether an adjustable single-incision mini-sling (SIMS, Ajust(®) ) is safe and effective in the management of female stress urinary incontinence (SUI) at 12 months follow-up. To determine whether it is feasible to be performed under local anesthesia (LA).

MATERIALS AND METHODS

The present study is a multicentre prospective cohort study in which 90 female patients underwent SIMS-Ajust(®) using a standardized insertion technique. The last 45 women were offered the procedure under LA. All patients completed their 12-month follow-up.

RESULTS

The patient-reported success rate, using Patient Global Impression of Improvement (PGI-I), was 80% at 12 months follow-up and a further 6% (n= 5) reported themselves to be 'improved'. In all, 32/45 (71%) patients agreed to undergo the procedure under LA while one patient required conversion to general anaesthetic. There was no organ damage or requirement for blood transfusion. Significantly lower rates of blood loss (P= 0.025) and postoperative voiding difficulties (P= 0.026) were seen in the LA group. The re-operation rate for SUI was 6% at 12 months.

CONCLUSIONS

SIMS (Ajust) appears to be a safe procedure, which is feasible under LA. SIMS (Ajust) have an 80% patient-reported success rate at 12 months follow-up.

摘要

目的

在 12 个月的随访中,确定可调节单切口迷你吊带(SIMS,Ajust(®))在女性压力性尿失禁(SUI)管理中的安全性和有效性。确定在局部麻醉(LA)下进行的可行性。

材料与方法

本研究是一项多中心前瞻性队列研究,其中 90 名女性患者采用标准化插入技术接受 SIMS-Ajust(®)治疗。最后 45 名女性接受 LA 下的手术。所有患者均完成 12 个月的随访。

结果

采用患者总体印象改善(PGI-I)进行患者报告的成功率为 12 个月随访时为 80%,另有 6%(n=5)的患者自述“改善”。共有 32/45(71%)名患者同意在 LA 下进行手术,1 名患者需要转为全身麻醉。无器官损伤或需要输血。LA 组的出血量(P=0.025)和术后排尿困难(P=0.026)明显较低。SUI 的再次手术率为 12 个月时为 6%。

结论

SIMS(Ajust)似乎是一种安全的手术,在 LA 下可行。SIMS(Ajust)在 12 个月的随访中,患者报告的成功率为 80%。

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