FDA update – March 9, 2011

FDA issues new Guidance on Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence

Urinary incontinence is defined as the involuntary loss of urine. It is a common health problem, especially among women. Depending on the definition of urinary incontinence used, the prevalence ranges from 5% to 50% of the adult U.S. population. The prevalence of urinary incontinence also increases with advancing age, implying that the impact of this condition is likely to increase over the next several decades as the growing U.S. population ages. Urinary incontinence is associated with poor self-rated health and quality of life, social isolation, and depressive symptoms and is a significant medical condition with considerable public health impact.

The ultimate goal when investigating a urinary incontinence device is

  • To design a study using objective,
  • Unbiased outcomes to measure the safety and effectiveness of the device.

Major challenges faced when designing a clinical study to assess the safety and effectiveness of a urinary incontinence device includes:

  1. Inherent variability and subjectivity of the typical outcome measures commonly used to assess the device effectiveness, 
  2. The significant placebo effect associated with some of these outcome measures, and
  3. The heterogeneous nature of the general patient population
  4. Quality of life is an important outcome measure, it is subjective and inherently difficult to measure reliably, and may be age- and symptom-dependent.

  5. There is a strong behavioral component to urinary incontinence, and enrollment in a clinical study in and of itself may make subjects more aware of their voiding habits and potential risk factors.

  6. Patients’ activities of daily living (e.g., mobility, recreation, exercise) and daily habits (e.g., diet, fluid intake) are difficult to control, yet can directly affect the frequency and amount of urine loss. Thus, variability in the types and levels of activities among patients seeking treatment for urinary incontinence is an important issue.

FDA’s new guidance document addresses:

  • The general clinical study design concepts that to be considered when designing clinical investigations of medical devices indicated for the treatment of urinary incontinence.
  • Does not address preclinical testing issues, which should, on a case-by-case basis, take into account the specific clinical indications and technology of the device.
  • Intended to cover any type of urinary incontinence device undergoing clinical investigation to support a marketing submission or application.
  • While, in general, clinical studies may not be needed for most class I and II urinary incontinence devices, FDA may recommend that you collect clinical data for a class I and II urinary incontinence device with any one of the following:
  • Indications for use dissimilar from a legally marketed device of the same type;
  • Designs dissimilar from designs previously cleared under a premarket notification; or
  • New technology, i.e., technology different from that used in legally marketed devices of the same type.

If there are any questions on these new FDA Rule please contact us via email at info@mdiconsultants.com  and Ref: Urinary Incontinence.