Randomized, Controlled Trials Needed for Incontinence Devices

Randomized, controlled clinical trials are generally the least burdensome way to collect safety and effectiveness data for urinary incontinence devices, the FDA says in a draft guidance. The major challenges sponsors face in designing such studies for urinary incontinence devices include the inherent variability and subjectivity of the typical effectiveness outcome measures, the significant placebo effect associated with some of these outcome measures and the diverse nature of the general patient population. Comments are due Dec. 18.