NCT01355133

Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence

Transurethral Ultrasound-directed Injection of Autologous Myoblasts in Combination With Functional Electrical Stimulation in Patients With Intrinsic Urinary Sphincter Deficiency

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot clinical study is to determine if intrasphincteric autologous myoblast injections in combination with electrical stimulation are safe and effective in treating stress urinary incontinence, confirming the optimal dose and assessing tolerability of the procedure.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Transurethral intrasphincteric autologous myoblast implantation	Patients undergo upper arm muscle biopsy to isolate and cultivate autologous myoblasts. Using the ultrasound-directed transurethral medical device, 15-18 aliquots (50 - 100 µl per depot) of the 2 ml myoblasts/media suspension are directly injected into the urethral rhabdosphincter at two different levels. The procedure is a single-dose injection of a cell count in range of 1x106 -5x107 cells, depending of the size/quality of the biopsy and quality of outgrowing cells in order to identify possible dose related effects. To possibly enhance cell integration following implantation, a course of transvaginal electrical stimulation is undertaken.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-05-17
• Last updated: 2011-05-17

Locations

1 site across 1 country: Slovenia