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<0.0001), the researchers said
A estimated 165,000 women a year in the U.S. have surgery for stress incontinence.
The findings "can be seen as the beginning of a new era in urogynecology," said Giacomo Novara, M.D., of the University of Padua and Walter Artibani, M.D., of the IRCCS Instituto Oncologico Veneto, both in Padua, Italy, in an accompanying commentary.
Drs. Novara and Artibani said the urological community has been waiting for the results since 2003, when preliminary observations of the procedure were reported.
The results of the current randomized controlled trial are "impressive, both in terms of efficacy and tolerability of the new procedure," they said, although larger multicenter studies, with longer follow-up, should be performed.
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:
90% of the women who got the experimental procedure were continent, compared with 9.5% of those who got collagen injections. The difference was significant at P<0.0001.
On average, the rhabdosphincter of the treated women was a millimeter thicker than those in the control group - 3.38 versus 2.32 mm.
Contractility of the rhabdosphincter was also better - 1.56 mm versus 0.67.
There was no significant difference in the thickness of the urethra.
Dr. Strasser and colleagues said that after a median follow-up of three years no severe side-effects or scars have been reported in any of the 63 volunteers, and postoperative results have not changed. They added that long-term post-operative data are needed and more studies are needed before the procedure can be established as a standard incontinence treatment.
Dr. Strasser and co-author Rainer Marksteiner, Ph.D., are co-owners of Innovacell Biotechnologie, while co-author Martin Fussenegger, M.D. is an owner of IGOR The companies run certified facilities where the autologous cells were grown. Eva Margreiter, Ph.M., is an employee of Innovacell. The study was supported by a grant from the Medical University Innsbruck. Primary source: The LancetSource reference: Strasser S et al. "Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial." Lancet 2007; 369: 2179-86 Additional source: The LancetSource reference: Giacomo Novara and Walter Artibani. "Myoblasts and fibroblasts in stress urinary incontinence." Lancet 2007; 369: 2139-40.
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