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

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.