inFlow’s Clinical Role

Meeting an Unmet Need

The inFlow™ Intraurethral Valve-Pump (“the inFlow device” or “the inFlow”) is a non-surgical voiding prosthesis for women with chronic urinary retention (CUR) of neurologic origin that is indicated for use as an alternative to intermittent catheters. The inFlow device is normally replaced every 29 days, but can be easily and safely removed at any time, even by patients.

While CUR in men is typically the result of prostatic obstruction caused by benign prostatic hyperplasia (BPH), CUR in women is most often a consequence of life-altering neurologic disease or injury, such as advanced MS, spinal cord injury, Parkinson’s, multiple system atrophy, diabetes, etc. When a neurologic condition impedes the ability to spontaneously urinate, this is commonly referred to as impaired detrusor contractility (IDC).

Although there are multiple surgical procedures and targeted medications for BPH, there are no similar interventions for women with CUR and the primary medical treatment option is use of urinary catheters. The current standard of care is clean intermittent catheterization (CIC) and it is the initially recommended treatment for women with PUR.

Since CIC requires insertion of a tube into the bladder 4-6 times per day, it is usually practical only for those who can self-catheterize. The problem is that many women with IDC cannot perform this procedure because their primary neurologic condition has limited their manual dexterity, visual acuity or ability to position themselves. Others find CIC’s procedural requirements too demanding to maintain, resulting in low long-term compliance. Those who cannot or will not perform CIC typically end up with a Foley catheter, despite the high rate of catheter-associated urinary tract infections (CA-UTIs) and low quality of life known to result.

The inFlow device can be used by many women who are unable or unwilling to self-catheterize and has been shown to reduce infection rates even compared to CIC. Just as important to its users, the inFlow can restore their ADL function and personal dignity by allowing almost normal use of a toilet.

Adverse events are similar to those for urinary catheters. The inFlow has been the subject of seven clinical studies (total N=501), none of which reported any serious or long-lasting adverse events associated with device use. (Please refer to IFU for more information on its safety profile.)