Urinary tract infections (UTIs) are caused by microorganisms that enter the urethra and
cause inflammation. These infectious microbes can migrate up the urinary tract into the
bladder, the ureters, and finally into the kidneys if untreated. UTIs ascending to the
kidneys are responsible for up to 100,000 hospitalizations each year, and primarily occur
in post-menopausal women or catheterized men. Infection of the urethra or bladder most
frequently causes symptoms including frequent and intense urge to urinate, burning
sensation during urination, cloudy or bloody urine, and pelvic pain. Infection that
progresses to the kidneys most frequently causes symptoms including back or flank pain,
fever, chills, and vomiting. The most common treatment for uncomplicated UTIs is oral
antibiotics, which are usually effective but have undesirable side effects such as
diarrhea and vaginal yeast infection and carry risks to vital organs, including the
kidney itself. Repeated use of antibiotics is also the major cause of antibiotic
resistance. Therefore, development of an alternative treatment or prevention strategy is
desirable.
The microbiota of the urogenital tract is abnormal in female patients with recurrent UTI
compared with that of healthy women. One known risk factor for UTIs is the loss of
lactobacilli in the vaginal flora; physical proximity of the urethral orifice to the
vaginal introitus explains the connection. Together, these data suggest there may be a
role the vaginal microbiota, particularly lactobacilli, play in maintaining urogenital
health and reducing the risk of UTI. The Flourish HEC Vaginal Care System is an
over-the-counter vulvovaginal wellness system comprised of three products already
commercially available that may help support the environment needed for the healthy
microbes to thrive. ("HEC" designates hydroxyethylcellulose, a natural gelling ingredient
used in this system, differentiating it from an earlier Flourish system which used aloe
gel).
Normal premenopausal vaginal flora is lactobacilli dominant. Estrogen drives the
maturation and thickening of the vaginal epithelium, including the production of large
quantities of glycogen. Glycogen is metabolized to smaller units such as maltose,
maltotriose, and dextrans, which serve as the fuel for lactobacilli. Lactobacilli
maintain vaginal pH in the acidic range by producing lactic acid; this both supports the
lactobacilli and keeps the growth of pathogenic bacteria at low levels. Most
Lactobacillus spp., including those associated with the healthiest vaginal environments,
produce racemic lactic acid. Lactobacilli also produce proteins with bactericidal
activity which help to maintain their dominance. But the primary tool lactobacilli depend
on to maintain their competitive advantage is the acidity they produce. Because of this
circle of pH and lactobacilli levels, anything that alters the vaginal flora and/or
changes the pH to a more basic environment will reduce vaginal lactobacilli levels and
may increase the risk of UTI. This circle is especially difficult to break after
menopause due to the loss of estrogen which leads to loss of fuel for lactobacilli.
Menopausal women with a history of recurrent UTI will be recruited to participate in a
clinical trial to determine whether use of a vaginal hygiene system can reduce frequency
of UTI. Women in the intervention group will use an over-the-counter kit for six months;
these products are already available on the market. Changes in vaginal microbiome,
changes in vaginal pH, changes in symptoms of genitourinary syndrome of menopause, and
frequency of UTI over the six-month study will be assessed and compared to controls
following routine care only.
