Incontinence implants set to enter US trials:
This article was originally published in Clinica
Executive Summary
An injectable treatment for female stress incontinence, which has been available in Europe for eight years, is set to undergo clinical trials in the US in the autumn. The FDA has granted Minneapolis, Minnesota-based Uroplasty an investigational device exemption for its Macroplastique implant, which is injected into the tissue surrounding the urethra as a bulking agent to enhance sphincter function. It is also used outside the US for incontinence in men after prostate surgery and vesicoureteral reflux in children.