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
{"title":"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。","authors":"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","doi":"10.1007/s00345-025-05562-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>This study was registered in the Iranian Registry of Clinical Trials (IRCT).</p><p><strong>Registration number: </strong>IRCT201611278554N3 Registration Date: 2017-05-28.</p>","PeriodicalId":23954,"journal":{"name":"World Journal of Urology","volume":"43 1","pages":"190"},"PeriodicalIF":2.8000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Application of human breast acellular dermal matrix (hbADM) in sling surgery for female stress urinary incontinence: a phase 1 clinical trial.\",\"authors\":\"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\",\"doi\":\"10.1007/s00345-025-05562-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>This study was registered in the Iranian Registry of Clinical Trials (IRCT).</p><p><strong>Registration number: </strong>IRCT201611278554N3 Registration Date: 2017-05-28.</p>\",\"PeriodicalId\":23954,\"journal\":{\"name\":\"World Journal of Urology\",\"volume\":\"43 1\",\"pages\":\"190\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-03-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"World Journal of Urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00345-025-05562-z\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"World Journal of Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00345-025-05562-z","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Application of human breast acellular dermal matrix (hbADM) in sling surgery for female stress urinary incontinence: a phase 1 clinical trial.
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).
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.
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