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前瞻性多中心试验的 5 年结果:AdVance XP 治疗具有良好预后因素的前列腺切除术后尿失禁患者。

Five-Year Results of a Prospective Multicenter Trial: AdVance XP for Postprostatectomy-Incontinence in Patients with Favorable Prognostic Factors.

机构信息

Department of Urology, University of Munich (LMU), Munich, Germany,

Department of Urology, University of Munich (LMU), Munich, Germany.

出版信息

Urol Int. 2021;105(5-6):421-427. doi: 10.1159/000512881. Epub 2021 Jan 29.

Abstract

OBJECTIVE

The aim of this study was to assess the security, value, and efficacy of the second-generation AdVance male sling XP (Boston Scientific®), after implementation in 2010 with advantageous modifications in the sling structure and needle shape, in a prospective multicenter long-term follow-up study.

METHODS

In total, 115 patients were included. Exclusion criteria were earlier incontinence (UI) surgery, nocturnal UI, former radiotherapy, or night-time incontinence. We also excluded patients with a functional urethra <1 cm in a preoperatively performed repositioning test. A consistent 24-h pad test, International Quality of Life (IQOL) score, visual analog pain scale (VAS), International Consultation-Incontinence Questionnaire (ICIQ-UI SF), International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), and Patient Global Impression of Improvement (PGI-I) scores were requested postoperatively.

RESULTS

The 24-month follow-up (114 patients) revealed 64.0% cured and 28.8% improved patients. Mean urine loss was reduced significantly to 19.0 g (p < 0.001). A mean PGI score of 1.5 and a mean VAS score of 0.2 were obtained. The 60-month follow-up (59 patients) revealed 57.6% cured and 25.4% improved patients. Mean urine loss was reduced significantly to 18.3 g (p < 0.001). A mean PGI score of 1.6 and a mean VAS score of 0.2 were obtained.

CONCLUSIONS

The AdVance XP displays excellent continence results and secure effectiveness over a 5-year period. Moreover, these data are demonstrating low complication rates and improved quality of life in the long-term use of AdVance XP.

摘要

目的

本研究旨在评估第二代 Advance 男性吊带 XP(波士顿科学公司)的安全性、价值和疗效,该吊带于 2010 年推出,在吊带结构和针头形状方面进行了有利的改进,并在一项前瞻性多中心长期随访研究中进行评估。

方法

共纳入 115 例患者。排除标准为早期尿失禁(UI)手术、夜间 UI、既往放疗或夜间尿失禁。我们还排除了在术前重新定位试验中功能尿道<1cm 的患者。术后要求进行一致的 24 小时垫试验、国际生活质量(IQOL)评分、视觉模拟疼痛量表(VAS)、国际尿失禁咨询问卷-尿失禁简短问卷(ICIQ-UI SF)、国际勃起功能指数(IIEF-5)、国际前列腺症状评分(IPSS)和患者总体改善印象(PGI-I)评分。

结果

24 个月随访(114 例患者)显示,64.0%的患者治愈,28.8%的患者改善。平均尿失重量显著减少至 19.0g(p<0.001)。PGI 评分为 1.5,VAS 评分为 0.2。60 个月随访(59 例患者)显示,57.6%的患者治愈,25.4%的患者改善。平均尿失重量显著减少至 18.3g(p<0.001)。PGI 评分为 1.6,VAS 评分为 0.2。

结论

AdVance XP 在 5 年内显示出出色的控尿效果和安全有效性。此外,这些数据表明,AdVance XP 的长期使用具有较低的并发症发生率和改善的生活质量。

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