Current treatment options for stress urinary incontinence (SUI) include pelvic floor physical therapy, incontinence pessaries, bulking agents and sling surgery, all of which aim to support urethral anatomy. Potential alternatives to these therapies are regenerative therapies which use progenitor cells to regenerate the urinary sphincter. Two phase 2 clinical studies have shown that autologous muscle-derived cells can be safely and effectively injected into the urethral sphincter for the treatment of SUI.(1)
A phase 3, randomized, double blind, placebo-controlled, multi center trial investigating the safety and efficacy of autologous muscle-derived progenitor cells for urinary sphincter repair in women is currently recruiting subjects in the United States, Belgium, Germany and The Netherlands . The study is sponsored by Cook, and investigates the Cook MyoSite technology for development of autologous progenitor cells for SUI in women.
Subjects undergo a biopsy of the quadriceps femoris under local anesthesia. The muscle cells are then processed and at a later date injected transurethrally into the urinary sphincter. Subjects in the placebo arm of the study will receive a placebo injection. The primary outcome measure of the study is number of SUI leakage episodes during a 12-month period.
Study candidates must be women, 18 years of age or older with the following: SUI on cough stress test, Q-tip angle less than 30 degrees, body mass index less than 35 and no history of neurologic disease. There are other inclusion and exclusion criteria. The study aims to enroll 267 patients .
(1) Peters KM, Domochowski RR, Carr LK, et al. Autologous muscle derived cells for treatment of stress urinary incontinence in women. J Urol. 2014 Aug:192(2):469-476.
Article by Howard Goldman, produced for the Publications and Communications Committee