PURPOSE: Intraurethral injection of in vitro expanded autologous skeletal muscle derived cells is a new regenerative therapy for stress urinary incontinence. We examined the efficacy and safety of a simpler alternative strategy using freshly harvested, minced autologous skeletal muscle tissue with its inherent content of regenerative cells.

MATERIALS AND METHODS: A total of 20 and 15 women with uncomplicated and complicated stress urinary incontinence, respectively, received intraurethral injections of minced autologous skeletal muscle tissue and were followed for 1 year. Efficacy was assessed by the number of leakages in a 3-day diary and by ICIQ-SF scores. We calculated the rates of cure, defined as zero leaks in 3 days plus an ICIQ-SF score of 5 or less, and improvement, defined as simultaneous decreases in each outcome measure.

RESULTS: Significant reductions were observed in each group in the mean number of leakages (p <0.01) and in ICIQ-SF scores (p <0.001). In the uncomplicated group cure and improvement were observed in 25% and 63% of patients, and in the complicated group they were noted in 7% and 57%, respectively. No voiding dysfunction developed and only minor adverse events were noted.

CONCLUSIONS: Intraurethral injection of minced autologous muscle tissue is a simple surgical procedure that appears safe and moderately effective in women with uncomplicated stress urinary incontinence. It compares well to a more complicated regenerative strategy using in vitro expanded muscle derived cells.