Concomitant Transurethral and Transvaginal-Periurethral Injection of Autologous Adipose Derived Stem Cells for Treatment of Female Stress Urinary Incontinence: A Phase One Clinical Trial.

Stress urinary incontinence is a common medical problem among women. The urethral closure complex and/or the supportive mechanisms are responsible for incontinence in the majority of patients. Several surgical procedures with different degrees of invasiveness and outcomes have been reported to treat the problem. Although most of these procedures are reasonably effective, a general trend towards the study of natural and biocompatible tissues is emerging over popular synthetic materials. Here we report our experience of autologous adipose-derived stem cells transplantation into the periurethral region as a new method of stress urinary incontinence treatment. Ten women with symptoms of stress urinary incontinence were treated by injections of autologous adipose-derived stem cells into the periurethral region via transurethral and transvaginal approach under urethroscopic observation. This report presents the short-term outcome of the patients. The outcome measured by pad test results, ICIQ-SF scores, and Qmax. The mean age of the participants was 45.8±8.7 years. Urinary incontinence significantly decreased through the first two, 6 and 24 weeks after the injection therapy. The difference was significant in pad test results (P<0.001) and ICIQ-SF scores (P<0.001), especially comparing results between 2 and 6 weeks and among 6 and 24 weeks, but not for 2 and 6 weeks compared to each other. Surprisingly, Qmax showed improvement after the study period (means 32.6 vs. 35.7; P=0.002). This study showed that injection of the autologous adipose-derived stem cells to the periurethral region is a safe, yet short-term effective treatment option for stress urinary incontinence. Further studies with longer follow up are needed to confirm its long term efficacy.