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[Ajust(®):前瞻性研究及1年随访——60例女性患者系列研究]

[Ajust(®): prospective study and 1-year follow-up - a series of 60 female patients].

作者信息

Vandendriessche D, Engrand J B, Debodinance P

机构信息

Département de gynécologie obstétrique, centre hospitalier Dunkerque, GCS Flandre-Maritime, avenue de la Polyclinique, 59760 Grande-Synthe, France.

出版信息

Prog Urol. 2013 Oct;23(12):994-9. doi: 10.1016/j.purol.2013.04.001. Epub 2013 May 25.

DOI:10.1016/j.purol.2013.04.001
PMID:24090784
Abstract

OBJECTIVES

Evaluate functional and anatomical outcomes as well as complications, 1year after the implantation of the Ajust(®) sub-urethral adjustable single-incision sling.

STUDY DESIGN

Prospective study on 60 female patients suffering from stress urinary or mixed urinary incontinence with quality of life assessment. Ambulatory surgeries were performed under local anesthesia with or without sedation. Pain was evaluated using the VAS scale. Postoperative follow-up was performed at 2 and 12months.

RESULTS

Forty-eight patients suffered from stress incontinence only, with one of them suffering from sphincter deficiency, and the remaining 12 suffered from mixed urinary incontinence. Mean surgery time was 7.15minutes. All patients received a local anesthesia, and 33 were sedated. Per-operative pain level was equal to 31.8/100, and 17/100 upon discharge. A 100mL per-operative hemorrhage was described. At 2-month follow-up, four de novo urgency, four de novo dysuria, one urinary infection, 11 palpable lateral cords, 12 moderate postoperative pain were described. At 1-year follow-up, two mesh exposures formed, including one expelled anchor for one of them. At 1year, cure rate, improvement and failure rate were respectively 89.6%, 6.9% and 3.4%. Quality of life indexes were significantly improved. One patient required a new surgery at 2months, due to initial failure.

CONCLUSIONS

The efficacy of this mini-invasive sling, without specific complication, must be compared with the other classic sub-uretral slings.

摘要

目的

评估Ajust(®)尿道下可调节单切口吊带植入1年后的功能和解剖学结果以及并发症。

研究设计

对60例患有压力性尿失禁或混合性尿失禁的女性患者进行前瞻性研究,并进行生活质量评估。在局部麻醉下进行门诊手术,可选择是否使用镇静剂。使用视觉模拟评分量表(VAS)评估疼痛程度。术后分别在2个月和12个月进行随访。

结果

48例患者仅患有压力性尿失禁,其中1例存在括约肌功能不全,其余12例患有混合性尿失禁。平均手术时间为7.15分钟。所有患者均接受局部麻醉,33例使用了镇静剂。术中疼痛程度为31.8/100,出院时为17/100。术中出血量为100mL。在2个月的随访中,有4例新发尿急、4例新发排尿困难、1例泌尿系统感染、11例可触及侧索、12例术后中度疼痛。在1年的随访中,出现了2例网片外露,其中1例伴有锚钉脱出。1年后,治愈率、改善率和失败率分别为89.6%、6.9%和3.4%。生活质量指标显著改善。1例患者因初始治疗失败在2个月时需要再次手术。

结论

这种微创吊带的疗效且无特定并发症,必须与其他经典的尿道下吊带进行比较。

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