NATIONAL HARBOR, MD. – After 12 months, an adjustable, single-incision sling significantly improved clinical and quality of life measures associated with stress urinary incontinence in women.
The Altis sling decreased the Urinary Distress Index (UDI) from a mean of 55 to a mean of 10, Dr. Douglas Van Drie said at a meeting sponsored by the AAGL. The Incontinence Impact Questionnaire (ILQ-7) showed similar improvements at the interim assessment of the device’s 2-year safety and efficacy study.
The study was sponsored by Coloplast, which makes the sling, with input and monitoring by the Food and Drug Administration. Altis was approved in November 2012 based on an investigational device exemption study, which included implant data. The FDA efficacy requirement was a 50% decrease in pad weight by 6 months.
According to the company website, "Altis is a unique, minimally invasive sling that combines integrated two-way tensioning with lightweight sling material to provide strength, security, and adjustability."
Physicians are divided on their thoughts about a single-incision sling, said Dr. Van Drie, a urogynecologist in group practice in Grand Rapids, Mich. "Those [physicians] who use them are advocates for their safety and simplicity, and the ability to insert them in the office. They have been adopted in different areas of the world as an option for doing simplified, less costly incontinence surgery. The argument against is questions about their staying power – will the effect hold up long term?" he said.
Even though the Altis is a single-incision sling, it has a "very secure" anchoring system, Dr. Van Drie said. The anchor not only goes into the obturator internus, but into the membrane and the obturator externus.
The study involved 113 women, with a mean age of 54 years. Their histories included stress incontinence with hypermobility (81%), without hypermobility (19%), mixed incontinence (37%), and overactive bladder (5%).
Most of the procedures were performed during an inpatient hospital stay (59%); however, 24% were performed at an ambulatory surgical center and 17%, in the physician’s office. General anesthesia was used in 52%, spinal in 3%, and local in 45%.
At 12 months, 90% of patients had at least a 50% reduction in pad weight, and 90% had a negative cough stress test result. The UDI decreased by a mean of 46 points, and the IIQ-7 score, by a mean of 47 points.
There were 11 device-related failures in eight patients. These included one each of urinary retention, urinary tract infection, decreased urine stream, dyspareunia, inflammation, worsening of overactive bladder, and voiding dysfunction. There were four mesh extrusions (3.5%), all less than 3 cm. Two patients with extrusion were smokers, and one was diabetic.
Serious adverse events occurred in three patients: One with a hematoma, one patient who needed transfer to the operating room because of anxiety during repair of a 2-mm mesh extrusion, and one patient whose adverse event was changed to a severe adverse event when she moved out of the study. There were no unanticipated device effects, Dr. Van Drie noted.
Dr. Van Drie is a consultant for Coloplast and has received research money and grants from the company.