ROYAL OAK — Findings from a multi-center trial led by researchers at Beaumont Hospital in Royal Oak may give urologists another minimally invasive treatment option for women with stress urinary incontinence.
The study showed that treating a woman with her own muscle-derived stem cells was both safe and effective. Unlike surgical treatments, this procedure takes place in a physician’s office.
According to the National Institutes of Health, millions of women experience urinary incontinence, a medical condition that causes involuntary loss of urine. There are several types of incontinence. This study focused on women with stress urinary incontinence, the most common type, affecting women of all ages. It causes leakage of urine when sneezing, coughing, lifting, laughing or physical exertion.
The study’s principal investigator, Kenneth Peters, M.D., medical director, Women’s Urology Center, Beaumont Health System; and professor and chairman of Urology, Oakland University William Beaumont School of Medicine presented the results at the American Urological Association’s Annual Meeting on May 22 in Atlanta.
Along with Beaumont, Royal Oak; Vanderbilt University Medical Center in Nashville, Tenn.; and Sunnybrook Health Sciences Centre in Toronto, Canada served as study sites.
The three sites enrolled 64 participants. Cells were taken from a biopsy of the patient’s thigh muscle, which was then sent to a laboratory where stem cells were isolated from the muscle. The isolated cells were cultured to grow more of the patient’s stem cells. After six to eight weeks, the stem cells were available for treatment. The cells were injected into the sphincter. Four different doses were studied over one year: 10 million cells; 50 million cells; 100 million cells; and 200 million cells.
“This was an incredibly safe method of treatment,” Peters said. “There were no significant side effects. Also noteworthy, is the majority of patients treated had a significant improvement in their urinary leakage and up to 60 percent of the women became dry, leading to an improved quality of life. Because of the positive results, our research team is considering a larger phase III trial.”
The women who participated in the study were age 18 and older with symptoms of stress urinary incontinence. They failed prior treatment for their condition and showed no improvement in their symptoms over the previous six months.
“It’s a very practical study that applies stem cell technology, specifically muscle-derived cells. We’re treating patients with their own tissue – their own building blocks,” Peters said. “And we’re moving from a surgical to an office-based treatment.”
The study was funded by Cook MyoSite Inc. in Pittsburgh, a Cook Group company.
More at www.beaumont.edu.