Maurizio Serati, Chiara Scancarello, Giada Mesiano, Chiara Cimmino, Maria Rosaria Campitiello, Stefano Salvatore, Fabio Ghezzi, Giorgio Caccia, Andrea Papadia, Andrea Braga
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Our aim was to investigate long-term subjective and objective outcomes after injection of Macroplastique, a urethral bulking agent.</p><p><strong>Methods: </strong>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.</p><p><strong>Key findings and limitations: </strong>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. 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引用次数: 0
摘要
背景和目的：直到几年前，尿道中段吊带一直被认为是保守疗法失败后治疗女性压力性尿失禁（SUI）的金标准。然而，有关网片暴露率和缺乏长期疗效的批评导致人们重新考虑其他手术方法。我们的目的是研究注射尿道膨出剂 Macroplastique 后的长期主观和客观效果：方法：我们前瞻性地登记了所有主诉单纯 SUI 症状并经尿动力学证实 SUI 的连续女性，她们都接受了 Macroplastique 注射。我们使用国际尿失禁咨询问卷-简表、尿道窘迫量表、患者总体改善印象和视觉模拟量表（VAS）问卷调查了患者报告的主观结果，并使用咳嗽压力测试评估了客观结果。随访期间记录了不良事件：注射 Macroplastique 10 年后，客观治愈率为 56%，71% 的患者表示满意。长期数据显示，主观和客观治愈率均无明显下降。没有严重并发症的报道。研究的局限性包括样本量较小，术后评估缺乏尿垫测试和膀胱日记：患者总结：我们评估了压力性尿失禁（SUI）女性患者的治疗效果，她们在尿道壁注射 Macroplastique 凝胶以防止漏尿。我们发现，这是一种治疗女性 SUI 的安全选择，而且长期有效。
Macroplastique Is a Safe and Effective Long-term Surgical Treatment for Stress Urinary Incontinence: Prospective Study with 10-Year Follow-up.
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.
期刊介绍：
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.
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