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Uretex Sup用于压力性尿失禁手术治疗的前瞻性多中心临床试验。

Prospective multicenter clinical trial of Uretex Sup for surgical treatment of stress urinary incontinence.

作者信息

Cortesse Ariane, Jacquetin Bernard, Grise Philippe, Le Normand Loïc, Richard François, Haab François

机构信息

Urology Department, St Louis Hospital, Assistance Publique-Hôpitaux de Paris, 1 Avenue Vellefaux, 75010 Paris, France.

出版信息

Int J Urol. 2007 Jul;14(7):611-5. doi: 10.1111/j.1442-2042.2007.01542.x.

DOI:10.1111/j.1442-2042.2007.01542.x
PMID:17645604
Abstract

AIM

To evaluate in a prospective multicenter study the efficacy and safety of the suburethral support Uretex (Sofradim, Trevoux, France) delivered by a suprapubic approach in the treatment of female stress urinary incontinence.

METHODS

Between March 2002 and March 2003, 57 patients were treated for stress urinary incontinence with Uretex. Preoperative evaluation included urodynamic examination and questionnaires (symptoms and quality of life, Contilife). Forty patients had pure stress urinary incontinence and 17 mixed urinary incontinence. No associated procedure was performed. The objective cure rate was evaluated by clinical examination and pad-test, and the subjective cure rate was assessed through questionnaires at 1, 3 and 12 months.

RESULTS

The mean follow-up was 13 months (range 11-24 months). During follow up, chronic urinary retention requiring a tape section occurred in one patient, and in another patient a delay of vaginal healing was followed by a sling exposure and resection at 4 months. No infection or urethral erosion was reported. The objective cure rate was 96.2%, and the subjective cure rate was 79.2%; four patients reported low leakage on stress and nine patients complained of urge incontinence (four de novo and five persistent).

CONCLUSION

The suprapubic Uretex Sup procedure is a safe and effective treatment for women with stress urinary incontinence.

摘要

目的

在一项前瞻性多中心研究中评估经耻骨上途径植入尿道下支撑物Uretex(法国特雷武索弗拉迪姆公司生产)治疗女性压力性尿失禁的疗效和安全性。

方法

2002年3月至2003年3月期间,57例压力性尿失禁患者接受了Uretex治疗。术前评估包括尿动力学检查和问卷调查(症状及生活质量,Contilife)。40例为单纯性压力性尿失禁,17例为混合性尿失禁。未进行相关联合手术。通过临床检查和尿垫试验评估客观治愈率,通过在1个月、3个月和12个月时进行问卷调查评估主观治愈率。

结果

平均随访13个月(范围11 - 24个月)。随访期间,1例患者发生慢性尿潴留,需要剪断吊带;另1例患者阴道愈合延迟,4个月时吊带暴露并切除。未报告感染或尿道侵蚀情况。客观治愈率为96.2%,主观治愈率为79.2%;4例患者报告在用力时仍有少量漏尿,9例患者主诉急迫性尿失禁(4例为新发,5例为持续性)。

结论

耻骨上Uretex Sup手术是治疗女性压力性尿失禁的一种安全有效的方法。

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引用本文的文献

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Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1075-9. doi: 10.1007/s00192-008-0578-y. Epub 2008 Feb 28.