Researchers are trying to determine whether inserting a surgical mesh sling in men undergoing radical prostate surgery for prostate cancer will help with incontinence issues. The biodegradable “sling” would be inserted during robot-assisted prostate cancer surgery and support the neck of the bladder and uretha after removal of the prostate gland.
The study, conducted by researchers at Indiana University School of Medicine, will assess urinary problems in patients following a complete removal of the prostate due to cancer. Half of the men in the study will receive one of the slings, while the others will receive current standard care without a sling. The bladder sling that will be used in this study was developed by Cook Medical in Bloomington, Ind.
Bladder slings have been an option for women suffering from incontinence for years, but the results have not always been favorable. The surgical mesh is used in women to repair pelvic floor disorders, such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The device designed for women is currently under review by the Food and Drug Administration (FDA) based on numerous complaints that the surgical mesh may cause serious complications, often requiring hospitalizations and additional surgeries.
Between 2005 and 2007, the FDA received “over 1,000” reports of complications from surgical mesh devices used to repair POP or SUI. Since then, for the years 2008 through 2010, the FDA received 2,874 additional reports of problems. The most frequent complication reported to the FDA included mesh erosion, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse (with POP), neruo-muscular problems, vaginal scarring/shrinkage, and emotional problems.
The FDA is currently reviewing data on the surgical mesh and is expected to comment once its review is complete.