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宏整形术是压力性尿失禁安全有效的长期外科治疗方法:一项为期10年随访的前瞻性研究。

Macroplastique Is a Safe and Effective Long-term Surgical Treatment for Stress Urinary Incontinence: Prospective Study with 10-Year Follow-up.

作者信息

Serati Maurizio, Scancarello Chiara, Mesiano Giada, Cimmino Chiara, Campitiello Maria Rosaria, Salvatore Stefano, Ghezzi Fabio, Caccia Giorgio, Papadia Andrea, Braga Andrea

机构信息

Department of Obstetrics and Gynecology, Del Ponte Hospital, University of Insubria, Varese, Italy.

Department of Obstetrics and Gynecology, Del Ponte Hospital, University of Insubria, Varese, Italy.

出版信息

Eur Urol Focus. 2024 Aug 2. doi: 10.1016/j.euf.2024.07.010.

DOI:10.1016/j.euf.2024.07.010
PMID:39095217
Abstract

BACKGROUND AND OBJECTIVE

Until a few years ago, a midurethral sling was considered the gold standard for the treatment of female stress urinary incontinence (SUI) after failure of conservative therapies. However, criticisms regarding the rate of mesh exposure and lack of long-term efficacy have led to reconsideration of other surgical procedures. Our aim was to investigate long-term subjective and objective outcomes after injection of Macroplastique, a urethral bulking agent.

METHODS

We prospectively enrolled all consecutive women complaining of pure SUI symptoms with urodynamically proven SUI who received a Macroplastique injection. We investigated patient-reported subjective outcomes using International Consultation on Incontinence Questionnaire-Short Form, Urogenital Distress Inventory, Patient Global Impression of Improvement, and Visual Analog Scale (VAS) questionnaires, and the cough stress test to assess objective outcomes. Adverse events were recorded during follow-up.

KEY FINDINGS AND LIMITATIONS

At 10 yr after Macroplastique injection, the objective cure rate was 56% and 71% of patients reported that they were satisfied. Long-term data revealed no significant decline in subjective or objective cure rates. No serious complications were reported. Study limitations include the small sample size and the lack of pad tests and bladder diaries for postoperative evaluations.

CONCLUSIONS AND CLINICAL IMPLICATIONS

Our study shows that Macroplastique injection can be an effective and safe option for the treatment of female SUI in the long term, even when used in the first-line setting.

PATIENT SUMMARY

We evaluated outcomes for women with stress urinary incontinence (SUI) who were treated with an injection of Macroplastique gel into the wall of the urethra to prevent leakage of urine. We found that this is a safe option for treatment of female SUI that is effective in the long term.

摘要

背景与目的

直到几年前,经尿道中段吊带术一直被视为保守治疗失败后女性压力性尿失禁(SUI)的金标准。然而,对网片暴露率及缺乏长期疗效的批评导致人们重新考虑其他手术方法。我们的目的是研究尿道填充剂Macroplastique注射后的长期主观和客观结果。

方法

我们前瞻性纳入了所有连续的、主诉单纯SUI症状且经尿动力学证实为SUI并接受Macroplastique注射的女性。我们使用国际尿失禁咨询委员会简表、泌尿生殖系统困扰量表、患者总体改善印象和视觉模拟量表(VAS)问卷来调查患者报告的主观结果,并通过咳嗽压力试验来评估客观结果。随访期间记录不良事件。

主要发现与局限性

在注射Macroplastique后10年,客观治愈率为56%,71%的患者报告满意。长期数据显示主观和客观治愈率均无显著下降。未报告严重并发症。研究局限性包括样本量小,以及缺乏用于术后评估的尿垫试验和膀胱日记。

结论与临床意义

我们的研究表明,即使在一线治疗中使用,Macroplastique注射长期来看也可以是治疗女性SUI的一种有效且安全的选择。

患者总结

我们评估了接受尿道壁注射Macroplastique凝胶以预防尿漏的压力性尿失禁(SUI)女性的治疗结果。我们发现这是治疗女性SUI的一种安全选择,且长期有效。

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引用本文的文献

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J Clin Med. 2024 Sep 28;13(19):5810. doi: 10.3390/jcm13195810.
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Long-Term Outcomes of Tension-Free Vaginal Tape Obturator: Efficacy and Safety at Long-Term Follow-Up.无张力阴道吊带闭孔术的长期结局:长期随访的疗效与安全性
J Clin Med. 2024 Sep 25;13(19):5699. doi: 10.3390/jcm13195699.