The US Food and Drug Administration (FDA) has cleared for marketing a replaceable urinary prosthesis for use in women with impaired detrusor contractility (IDC).
Called the inFlow Intraurethral Valve-Pump, it is manufactured by Vesiflo, Inc, of Redmond, Washington.
Women with IDC are unable to spontaneously urinate because of insufficient bladder muscle contraction, which can result from significant neurologic disease or injury such as stroke, multiple sclerosis, spinal cord injury, spina bifida, or diabetic neuropathy. IDC is typically managed with various types of catheters, including clean intermittent catheterization (CIC).
"The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag," William Maisel, MD, MPH, 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 has four parts: 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, the FDA says.
Initial insertion of the device is performed by a physician. After training, it can be inserted and removed by the patient or a caregiver. Each inserted component must be replaced at least once every 29 days.
The FDA reviewed data for inFlow through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to a legally marketed device.
The FDA granted the de novo request based on nonclinical testing and a clinical trial that enrolled 273 women with IDC using CIC. More than half of the women stopped using the device as a result of discomfort and leakage of urine. However, 98% of the 115 women who continued to use the inFlow device had postvoid residual urine volume comparable with the volume of those who used the CIC, the FDA says.
Adverse events associated with the inFlow device included asymptomatic bacteriuria, urinary tract infection (UTI), bladder inflammation, genitourinary pain, hematuria, urinary leakage around the device, urinary frequency/urgency, bladder spasms, and vulvar, vaginal, and urethral disorders.
The FDA says it's "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."