Treatment of male stress urinary incontinence using autologous adipose‐derived regenerative cells: Long‐term efficacy and safety

Objectives To investigate the long‐term efficacy and safety of periurethral injection of autologous adipose‐derived regenerative cells for the treatment of post‐prostatectomy stress urinary incontinence. Methods A total of 13 patients with persistent stress urinary incontinence after prostate surgery (radical prostatectomy, 10 patients; holmium laser enucleation of the prostate, three patients) underwent periurethral injection of adipose‐derived regenerative cells and were followed up for >4 years. A 24‐h pad test was carried out for four consecutive days in each evaluation period, and changes in the mean daily leakage volume during the 4 days from baseline to 60 months after treatment were evaluated. Results The mean follow‐up period was 69 months (range 55–72 months). The mean leakage volume/24 h in all patients changed from 260.7 g to 152.7 g. Urinary incontinence progressively improved up to 12 months after treatment in 10 patients, who maintained improvement up to the final assessment, with the mean daily leakage volume decreasing from 281.5 g to 119.0 g (reduction rate 57.7%). The other three patients showed no improvement at 1 year and at the final assessment. After the perioperative period, significant adverse events or prostate‐specific antigen increase were not observed during long‐term follow up. Conclusions The present findings suggest that periurethral injection of autologous adipose‐derived regenerative cells is a safe and feasible treatment modality with long‐term efficacy for patients with male stress urinary incontinence caused by urethral sphincter deficiency.