New approaches to treat stress urinary incontinence (SUI) have been investigated because of the limitations of existing methods of treatment. One new approach using tissue engineering involves the use of ultrasound-guided intrasphincteric autologous myoblast implantation to treat SUI.
This article and the accompanying video demonstrate the feasibility, efficacy, and safety of this approach in a pilot study conducted in 38 women. The study was an investigator-initiated, noncomparative clinical trial conducted at an academic center. Autologous progenitor cells from adult tissues were used to avoid the need for embryonic stem cells. Muscle tissue obtained from the upper arm by biopsy was used to prepare an autologous myoblast suspension, which was injected into the extrinsic urethral sphincter guided by ultrasound visualization. Postoperatively, participants self-administered functional electrical stimulation transvaginally for 5 weeks to enhance cell integration. To assess the results, objective and subjective measures were compared at 6 weeks, 3 months, and 6 months after implantation.
Cell harvest, tissue processing, and myoblast implantation were successful in all patients. There were no serious adverse events during the course of the study. Objective and subjective parameters measured at baseline were significantly improved 6 weeks postoperatively. At 3 and 6 months, additional improvement or a plateau was observed; improvements were not negatively affected by discontinuation of functional electrical stimulation at 5 weeks. Of the 38 patients, 9 (23.7%) considered their SUI to be cured, 20 (52.6%) were improved at 6 months, and 36 (95%) would recommend the treatment to others.
These findings suggest that intrasphincteric ultrasound-guided autologous myoblast injection is a promising approach for treatment of SUI. The procedure is minimally invasive, simple to perform, and well tolerated.