|A device that to help women with IDC has been |
approved by FDA.
A device to help women with a condition called impaired detrusor contractility (IDC), in which they can't contract bladder muscles needed to excrete urine, has been approved by the U.S. Food and Drug Administration. IDC can be caused by a neurologic problem, stroke or spinal cord injury, the FDA explained in a news release, and it is typically managed with various types of catheters, including clean intermittent catheterization (CIC).
The inFlow™ Intraurethral Valve-Pump has four components: a sterilized, single-use urethral insert component with silicone shaft, fins, and flange; an introducer; an activator; and a sizing component. The device draws urine out to empty the bladder and blocks urine flow when continence is desired. A physician sizes the patient for an inFlow device and performs the initial insertion. After training, device insertion and removal can be performed by the patient or a caregiver. Each inserted component must be replaced at least once every 29 days. The device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag. This may allow for increased mobility and the ability to be more self-sufficient.
The device was evaluated in clinical testing involving 273 users. More than half stopped using the device due to discomfort or leakage, the FDA said. The trial showed that 98 percent of the 115 women that continued to use the inFlow device had comparable post-void residual urine volume (measurement of the amount of urine left in the bladder after urination is complete) with those who used the CIC. Adverse events included urinary tract infection, bladder inflammation, pain, blood in the urine and bladder spasms. It is noteworthy that the most significant of these adverse events, UTI, appears to occur at a lower rate with the inFlow device as compared to CIC. Among patients treated with the inFlow device, UTIs were stable and easily managed with antibiotics.
The device is produced by Vesiflo Inc., based in Redmond, Wash.