More than 15 million women in the United States are impacted by stress urinary incontinence (SUI) at a cost of nearly $20 billion a year to treat.
Vanderbilt University Medical Center is the principal investigation site for a clinical trial to treat this common urologic condition. Now in the final phase, researchers are hoping to enroll patients in a randomized, double-blind, placebo-controlled trial to assist investigators in their efforts to obtain FDA approval and bring the therapy to market.
The treatment involves reinjection of cells derived from a woman’s own muscle tissue harvested from a biopsy of her leg, said Melissa Kaufman, M.D., Ph.D., assistant professor of Urologic Surgery and study co-investigator with principal investigator Roger R. Dmochowski, M.D., professor Urologic Surgery.
Study participants will have a biopsy of their leg to harvest starter cells, which are sent to a lab to expand the muscle cells. Once they are ready, the cells will be implanted into the urethral sphincter to allow regrowth and regeneration of the native sphincter muscle.
“This technology represents a new paradigm for treatment of incontinence and one that will open doors for many other urologic conditions as well,” Kaufman said. “There are several different therapies for SUI. We begin with a conservative approach with muscle exercises and physical therapy, but many women proceed to surgical procedures such as mesh slings, which, although effective, require surgical intervention.
“Women need options and alternatives to surgical treatments. This entire therapy is office-based, which makes it very attractive.”
Stress urinary incontinence is a significant quality of life issue, Kaufman said.
The study is seeking to enroll women 18 and older who are experiencing symptoms of stress urinary incontinence — any type of leaking with any increased abdominal pressure, coughing, sneezing or lifting for at least six months. The patient must have gone through a conservative management regimen that has not resolved the leakage issues.
The study period is 12 months. For every two patients who are randomized into the arm of the study to receive the cell treatment, one patient will fall into the placebo category.
But Kaufman said everyone enrolled in the trial will receive treatment.
“If a woman received the placebo treatment, she is allowed to return after the initial 12-month period to undergo the cell therapy,” said Kaufman. “We will follow them for an additional 12 months.
Kaufman notes that this is the first opportunity for women to benefit from regenerative medical therapies for urologic conditions.
“The design of this study is a win-win for participants, as even those women allocated to the placebo arm at first will eventually be treated with their own cells,” she said.
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