A minimally invasive device for treating recurrent stress urinary incontinence in women has been shown to be safe and effective in early clinical trials and is now under review by the U.S. Food and Drug Administration (FDA), says Emory University School of Medicine urologist and trial co-principal investigator Niall Galloway, MD.
Preliminary results from the North American Adjustable Continence Therapy (ACT) clinical study group were presented at the annual meeting of the American Urological Association convened in Anaheim, Calif.
The first phase of the multi-center ACT clinical trial, which included Emory, launched in December 2001 and will conclude in June. It tested the device in 160 women diagnosed with stress urinary incontinence who failed to respond to previous treatments.
During the outpatient procedure, which lasts 20-30 minutes, two adjustable balloons are implanted on each side of a patient's urethra. The ACT clinical trial patients on average reported significant continence improvement one year after undergoing treatment. Complications were usually mild.
"The ACT device spells hope for millions of women dealing with incontinence, particularly those who've experienced severe weakness of the urethra muscles," says Dr. Galloway. "Follow up is needed, but the results we have thus far are promising."
It's estimated that 13 million people in the U.S. suffer from incontinence, or loss of bladder or bowel control. At least 85 percent of sufferers are women.
A broad range of conditions and disorders can cause incontinence, including birth defects, pelvic surgery, injuries to the pelvic region or to the spinal cord, neurological diseases, multiple sclerosis, poliomyelitis, infection and degenerative changes associated with aging. It also can occur as a result of pregnancy or childbirth.
The ACT device developed by Uromedica, Inc. may appeal to women seeking a minimally invasive therapy with a shorter recovery time than offered by traditional incontinence surgical treatments, Dr. Galloway says. With ACT, there are no abdominal or vaginal incisions. The balloons can be adjusted post-operatively as needed, eliminating the risk of overtreatment or undertreatment, challenges posed by some existing therapies, he added. The ACT is also reversible. A similar device called ProACT is being tested in men with stress urinary incontinence after prostate surgery.