Urinary Prosthetic Device for Women Approved

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.

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, blood in the urine and bladder spasms.

The device is produced by Vesiflo Inc., based in Redmond, Wash.

More information

The FDA has more about this approval.