Wednesday, October 15, 2014 New Urinary Prosthesis Could be Alternative to Catheterization for Some Women The US Food and Drug Administration (FDA) has approved a replaceable urinary prosthesis that could free women with impaired detrusor contractility (IDC) from the mobility problems associated with catheters. The inFlow Intraurethral Valve-Pump is a replaceable device consisting of a sterilized single-use urethral insert, an introducer, an activator, and a sizing shaft. According to a news release from the FDA, the device "draws urine out to empty the bladder and blocks urine flow when continence is desired." Patients with IDC are unable to spontaneously urinate, a condition that can result from stroke, spinal cord injury, diabetic neuropathy, or other neurologic disease or injury. Typically patients with IDC must use some type of catheter, and are unable to experience continence. The FDA reported that in testing, more than half of the 273 women who used the new device stopped using it because of leakage or discomfort. Or those who continued to use the device, 98% had post-void urine volume similar to those recorded with clean intermittent catheterization (CIC). The FDA reported that though urinary tract infection was the most significant adverse event associated with the new device, rates of infection were lower than those associated with CIC. After initial sizing and training by a physician, insertion and removal of the device can be performed by the patient or caregiver. Inserted components must be replaced every 29 days. "The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag," said William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. "This may allow for increased mobility and the ability to be more self-sufficient." APTA has provided guidance to the federal Agency for Healthcare Research and Quality (.pdf) in its research efforts around urinary incontinence, and the association offers several resources to members and the public, including the APTA Section on Women's Health and the PT's Guide to Incontinence. PTs looking for evidence-based research on UI treatment can find resources at PTNow.