FDA Approves Urinary Prosthetic Device for Women
Device approved for impaired detrusor contractility
TUESDAY, Oct. 14, 2014 (HealthDay News) -- A device to help women with impaired detrusor contractility (IDC) urinate has been approved by the U.S. Food and Drug Administration.
The InFlow Intraurethral Valve-Pump contains four components, each of which must be changed after four weeks of use. It helps women with IDC urinate when desired and withhold urine at other times.
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. Other adverse reactions included urinary tract infection, bladder inflammation, pain, hematuria, and bladder spasms.
"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, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in a statement. "This may allow for increased mobility and the ability to be more self-sufficient."
The device is produced by Vesiflo Inc., based in Redmond, Wash.