Clinical use of the FemAssist device in female urinary incontinence

We sought to determine the safety and effectiveness of a new, simple noninvasive device, "FemAssist" for women suffering from urinary incontinence.

The "FemAssist" is a dome-shaped medical grade silicon device intended to be worn over the external urethral meatus and held in place by suction and an adhesive gel. Thirty eight women with varying degrees of genuine stress urinary incontinence (GSUI) or mixed incontinence on multichannel urodynamic testing were fitted with one of two sizes of "FemAssist" with regard to their anatomy and dexterity.

Thus far, of the 38 women who have completed the study, there have been no reported significant increases in bacteriuria or urinary tract infection rates. Over half of the women reported an improvement in the quality of life including comfort, convenience, and overall satisfaction. The device was worn for a total of 886 days by the group; 82% of these were dry days.

Our preliminary study suggests that the "FemAssist" device is safe and effective for some women with urinary incontinence.