The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).

IDC is a condition where patients are unable to spontaneously urinate due to insufficient bladder muscle contraction, which can result from significant neurologic disease or injury such as stroke, multiple sclerosis, spinal cord injury, spina bifida or diabetic neuropathy. IDC is typically managed with various types of catheters, including clean intermittent catheterization (CIC).

Today, NIH released a Guide Notice (NOT-OD-15-012) announcing that the response date for the Request for Information “Consideration of Sex As a Biological Variable in Biomedical Research,” has been extended to October 24th. If you have not had a chance to submit your thoughts, please do so by October 24th.

Perimenopause  is the time when a women naturally starts having menopausal symptoms.  This natural change usually lasts about a year and is often referred to as the ‘menopause transition’.  At  this time, fertility declines but a woman may still get pregnant, and effective birth control should be used if she does not want to have a mid-life baby.  Generally, after a year of no menses, a woman can be considered infertile and menopausal.

There are several appropriate birth control methods recommended for perimenopausal women:

Last Spring, CBS 60 Minutes, highlighted the fact that a popular prescription sleeping pill, Ambien, was causing next morning impaired driving in women.    This finding eventually resulted in the FDA halving the recommented dosage for women on the label.  Had the drug been well studied in both sexes, this difference would have been noted earlier in the discovery process with less adverse effects reported.  Now, there are steps being taken at the NIH and FDA to ensure both sexes are adequately included in drug and devices studies.