To assess the efficacy and safety of the application of autologous myoblasts and fibroblasts for treating female stress urinary incontinence (SUI) after a follow‐up of ≥1 year.

In all, 123 women with SUI (aged 36–84 years) were treated with transurethral ultrasonography‐guided injections with autologous myoblasts and fibroblasts obtained from skeletal muscle biopsies. The fibroblasts were suspended in a small amount of collagen as carrier material and injected into the urethral submucosa, while the myoblasts were implanted into the rhabdosphincter. All patients were evaluated before and 12 months after the injection using the Incontinence and Quality of Life Instrument (I‐QOL) scores, urodynamic variables, and morphology and function of the urethra and rhabdosphincter.

At 1 year after implanting the cells, 94 of the 119 women (79%) were completely continent, 16 (13%) had a substantial improvement and nine (8%) a slight improvement. Four patients were lost to follow‐up.The incontinence and I‐QOL scores, and the thickness, contractility and electromyographic activity of the rhabdosphincter were significantly improved after treatment.

These results show the efficacy and safety of transferring autologous myoblasts and fibroblasts in the treatment of female SUI, after a follow‐up of 1 year.