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Application of Human Breast Acellular Dermal Matrix (Hbadm) in Sling Surgery for Female Stress Urinary Incontinence: A Phase 1 Clinical Trial Publisher Pubmed



Moaveni AK1 ; Zargham M2 ; Vahidi S1 ; Zolbin MM1 ; Amiri M1 ; Mahmoodi M3 ; Menbari MN3 ; Ekhtiari M1 ; Azimzadeh A1 ; Ebrahimi R1 ; Rajipour N1 ; Kajbafzadeh AM1, 4
Authors
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Authors Affiliations
  1. 1. Pediatric Urology and Regenerative Medicine Research Center, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Female Urology of Alzahra Hospital, Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  3. 3. Department of Molecular Medicine, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran
  4. 4. No. 62, Dr. Gharib’s Street, Keshavarz Boulevard, Tehran, 1419433151, Iran

Source: World Journal of Urology Published:2025


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. © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2025.