TORONTO—Women who received a monofilament polypropylene, light-weight, macroporous midurethral sling (Aris, Coloplast, Denmark) showed significant improvement in stress urinary incontinence (SUI) at two years’ follow-up, according to an 11-center European study.
Christian Saussine, MD, PhD, Professor of Urology at the University of Strasbourg in Strasbourg, France, told Renal &Urology News that he has been using this sling for more than three years and has not yet seen data on other slings that would convince him to switch.
“I haven’t seen a randomized, controlled trial comparing different types of these ‘outside-in’ slings,” Dr. Saussine said. “Perhaps there are differences between the different types, but they have not been demonstrated to date.”
Study results were reported at the International Continence Society-International Urogynecological Association Joint Annual Meeting here.
Dr. Saussine and his co-investigators in Belgium, France, and Germany began recruiting patients beginning in July 2004. They implanted the slings in 668 women with SUI; 557 individuals were available for follow-up 75 days after implantation. In addition, 453 had at least one year’s follow-up and 390 had at least two years’ follow-up.
The perioperative and procedure-related complication rates were low. In addition, the investigators identified 12 cases of urinary retention and 11 cases of erosion or extrusion, which translates into a 0.07% and 0.06% rate of these complications, respectively, per month of their experience with the device.
Of patients available at the one-year follow-up visit, 95% said they were ‘satisfied’ or ‘very satisfied’ with the results of the procedure. At two years, 87% said they were ‘satisfied’ or ‘very satisfied’. Furthermore, their physicians determined, after thorough gynecological examination and, in some cases, urodynamic testing, that the procedure resulted in a significant improvement in incontinence in most cases.
Another specialist in the field, Maud Ankardal, MD, an obstetrician-gynecologist at the University of Gothenburg in Sweden, said that it is difficult to know if the study findings are generalizable because a large percentage of the patients were lost to follow-up and physician evaluation rather than objective assessment was used to determine the effectiveness of the slings.