INTRODUCTION & OBJECTIVES: In the present study safety and efficacy of transurethral ultrasound guided injections of autologous stem cells in treatment of urinary incontinence have been evaluated.

MATERIAL & METHODS: Between 2003 and March 2005 130 incontinent patients (age: 36-85 years; 85 women, 45 men) were included in a clinical study to investigate whether urinary stress incontinence can be effectively treated with transurethral ultrasound guided injections of autologous myoblasts and fibroblasts. The patients suffered from stress or mixed urinary incontinence.

Before and after therapy a defined incontinence score, changes in quality of life as well as morphology and function of urethra and rhabdosphincter were evaluated. Transurethral ultrasound was used to investigate and visualize the lower urinary tract. Furthermore, urodynamic and laboratory tests were performed pre- and postoperatively.

Small skeletal muscle biopsies were taken from the upper arm under local anaesthesia. The cells were then grown in a GMP-laboratory fulfilling strict clean room environment regulations. The fibroblasts were eventually mixed with a small amount of collagen as carrier material (about 2.5 ml). Using a transurethral ultrasound probe and a specially designed injection device, the fibroblasts were injected into the urethral submucosa to treat atrophies of the mucosa. The myoblasts were directly injected into the rhabdosphincter to reconstruct the muscle.

RESULTS: In 111 patients (79 women, 32 men) urinary incontinence was cured after injection of stem cells. Quality of life was dramatically improved postoperatively. Thickness of urethra and rhabdosphincter as well as activity and contractility of the rhabdosphincter were increased significantly after therapy. In 17 patients incontinence was improved postoperatively. No side effects or complications occurred.

CONCLUSIONS: The present data support the conclusion that this new therapeutic concept represents an effective and minimally invasive treatment modality to cure urinary incontinence.