INNSBRUCK, Austria -- A novel treatment to relieve stress incontinence in women, strengthening the urinary rhabdosphincter with cultured autologous tissue, has panned out.
INNSBRUCK, Austria, June 28 -- A novel treatment to relieve stress incontinence in women, strengthening the urinary rhabdosphincter with cultured autologous tissue, has panned out.
A year after the procedure, 38 of the 42 women who underwent the procedure were completely continent, according to Hannes Strasser, M.D. of the University of Innsbruck.
He and colleagues used autologous muscle and connective tissue cells -- extracted, grown in culture, and re-implanted - and found the approach safe and effective, they reported in the June 30 issue of The Lancet. In contrast, only two of 21 women in a control group given standard collagen injections were continent.
Other outcome measures, including the thickness and contractility of the rhabdosphincter, also improved significantly (P
Dr. Strasser and colleagues enrolled 63 women with stress incontinence and randomized them in a two-to-one fashion to either endoscopic injections of collagen into the periurethral tissue or to the experimental procedure.
The 42 women in the experimental arm, ages 36 to 84, had a muscle biopsy and blood sample taken, which were then taken to one of two centers in Austria certified to produce myoblasts and fibroblasts. Several of the authors have financial connections with the two centers.
After six to eight weeks of culture, the myoblasts were injected into the rhabdosphincter in 15 to 18 portions at two different levels in the middle third of the urethra, using an ultrasound transducer so the physicians could visualize the organs.
At the same time, the fibroblasts (with a small amount of collagen) were injected into the urethral submucosa in 25 to 30 places.
Because the two procedures were different, the study was not fully blinded, the researchers said, but the randomization was blinded, and those who collected and analyzed data did not know which women were in which group.
A year after the procedure, the researchers found: