Application of human breast acellular dermal matrix (hbADM) in sling surgery for female stress urinary incontinence: a phase 1 clinical trial.

IF 2.8 2区医学 Q2 UROLOGY & NEPHROLOGY

World Journal of Urology Pub Date : 2025-03-26 DOI:10.1007/s00345-025-05562-z

Amir Kian Moaveni, Mahtab Zargham, Simin Vahidi, Masoumeh Majidi Zolbin, Maryam Amiri, Mozaffar Mahmoodi, Mohammad Nazir Menbari, Masoumeh Ekhtiari, Ashkan Azimzadeh, Reyhane Ebrahimi, Nazanin Rajipour, Abdol-Mohammad Kajbafzadeh

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引用次数: 0

Abstract

Purpose: To evaluate the safety and feasibility of human breast acellular dermal matrix (hbADM) as an alternative to synthetic mesh and autologous fascia in sling surgery for female stress urinary incontinence (SUI), and to assess its preliminary efficacy in a phase 1 clinical trial.

Methods: Twenty-five women with pure SUI underwent hbADM sling surgery at two centers. The primary outcomes were safety (adverse events) and feasibility. Secondary outcomes included changes in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores, Patient Global Impression of Improvement (PGI-I), cough stress test results, and uroflowmetry parameters. Patients were followed up for 3 years. Statistical analysis included descriptive statistics, paired t-tests, and Wilcoxon signed-rank tests.

Results: The hbADM sling procedure was performed as planned in all patients. Adverse events occurred in 10 patients (40%). Intraoperative and early postoperative events (9/25, 36%) were mild and consistent with standard sling procedures. Late complications, observed in 2 patients (8%), were limited to recurrent urinary tract infections (UTIs); one of these patients had also presented a UTI in the early phase. No cases of sling erosion or chronic pain were observed. Objective cure rates (negative cough stress test) remained high at 100% at 1 year and 95% at 3 years. However, patient-reported success (PGI-I ≤ 2) declined from 92% at 1 month to 65% at 3 years. The mean ICIQ-SF score improved significantly from 15.3 ± 3.4 at baseline to 5.8 ± 2.4 at 3 years post-surgery (p < 0.001). Uroflowmetry parameters remained stable throughout the follow-up. The recurrence rate was 10% at 3 years.

Conclusion: This phase 1 trial demonstrates the safety and feasibility of hbADM slings for female SUI treatment, with promising efficacy outcomes up to 3 years post-surgery. These results support further investigation of hbADM sling in larger, randomized controlled trials.

Clinical trial registration: This study was registered in the Iranian Registry of Clinical Trials (IRCT).

Registration number: IRCT201611278554N3 Registration Date: 2017-05-28.

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人乳腺脱细胞真皮基质（hbADM）在女性压力性尿失禁悬吊手术中的应用：一项1期临床试验。

目的：评价人乳腺脱细胞真皮基质（hbADM）替代人工补片和自体筋膜用于女性压力性尿失禁（SUI）悬吊手术的安全性和可行性，并在1期临床试验中评估其初步疗效。方法：25例单纯SUI患者在两个中心接受了hbADM吊带手术。主要结局是安全性（不良事件）和可行性。次要结局包括国际失禁咨询问卷简表（ICIQ-SF）评分、患者总体改善印象（PGI-I）、咳嗽压力测试结果和尿流测量参数的变化。患者随访3年。统计分析包括描述性统计、配对t检验和Wilcoxon符号秩检验。结果：所有患者均按计划进行hbADM吊带手术。10例（40%）患者发生不良事件。术中和术后早期事件（9/25,36%）轻微，符合标准吊带操作。2例患者（8%）出现晚期并发症，仅限于复发性尿路感染（uti）；其中一名患者在早期也出现了尿路感染。没有观察到吊带糜烂或慢性疼痛的病例。客观治愈率（咳嗽压力试验阴性）保持在1年100%和3年95%的高位。然而，患者报告的成功率（pg - i≤2）从1个月时的92%下降到3年时的65%。平均ICIQ-SF评分从基线时的15.3±3.4分显著提高到术后3年的5.8±2.4分(p)。结论：该1期试验证明了hbADM吊带治疗女性SUI的安全性和可行性，术后3年疗效良好。这些结果支持在更大的随机对照试验中进一步研究hbADM吊带。临床试验注册：本研究已在伊朗临床试验注册中心（IRCT）注册。注册号：IRCT201611278554N3注册日期：2017-05-28。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

World Journal of Urology 医学-泌尿学与肾脏学

CiteScore

6.80

自引率

8.80%

发文量

317

审稿时长

4-8 weeks

期刊介绍： The WORLD JOURNAL OF UROLOGY conveys regularly the essential results of urological research and their practical and clinical relevance to a broad audience of urologists in research and clinical practice. In order to guarantee a balanced program, articles are published to reflect the developments in all fields of urology on an internationally advanced level. Each issue treats a main topic in review articles of invited international experts. Free papers are unrelated articles to the main topic.