Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
The purpose of this study is to determine if vaginal estrogen use is associated with
 resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The
 hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will
 have higher rates of resolution of hematuria after treatment course with vaginal conjugated
 equine estrogen cream compared to placebo cream
This is a randomized controlled trial of vaginal estrogen cream for postmenopausal women with
 microscopic hematuria (AMH). Potential subjects will be screened with a dipstick urinalysis
 of a catheterized urine specimen, followed by microscopic urinalysis and urine culture if
 urine dipstick is positive for trace blood or greater. Women who are identified as having
 asymptomatic microscopic hematuria (>3 red blood cells (RBC) per high powered field (hpf)) on
 a single urine microscopy specimen in the absence of urinary tract infection or other benign
 cause will be eligible for enrollment.

 Women meeting inclusion criteria will be randomized to either conjugated equine estrogen
 cream (Premarin, 0.625mg conjugated estrogens) or placebo cream for 8 weeks. Microscopic
 urinalysis of a catheterized urine specimen will be re-checked at 8 weeks to check for
 reduction, resolution or persistence of AMH. During the 8 weeks of vaginal estrogen or
 placebo, women will complete the recommended AMH workup as dictated by the American Urologic
 Association (AUA) guidelines (cystourethroscopy, serum blood urea nitrogen and creatinine
 levels, and computed tomography (CT) scan of the abdomen and pelvis with and without
 intravenous contrast).1

 Validated questionnaires to assess vaginal atrophy and symptoms of urinary urgency and
 frequency will be completed at time of randomization and again at 8 weeks. Cost analysis of
 the standard AMH workup (cystourethroscopy and CT scan) versus empiric treatment with 8 weeks
 of vaginal estrogen cream will be calculated based on Medicare reimbursement, as well as
 market price for vaginal estrogen cream Additionally, patients will be asked to complete a
 questionnaire to assess the level of bother associated with completing the current AMH workup
 of CT scan and cystoscopy as compared to completing a treatment course of vaginal estrogen
 cream.

 Secondary analyses will determine whether there are additional benefits to a trial period of
 vaginal estrogen cream in postmenopausal women with AMH prior to reflexively screening for
 urinary tract abnormalities. We will compare the cost of a standard AMH workup to a treatment
 course of vaginal estrogen cream, to determine whether vaginal estrogen with potential
 resolution of AMH is associated with any savings prior to pursuing further workup.
 Additionally, questionnaires will ask study participants whether they would prefer to undergo
 the current AUA AMH workup or a treatment course of vaginal cream, in order to assess bother
 and anxiety associated with these interventions.
Inclusion Criteria:

 -  Post-menopausal women

 -  Asymptomatic microscopic hematuria (three or more red blood cells per high powered
 field on a single urine microscopy) in the absence of urinary tract infection.

 Exclusion Criteria:

 -  Known urologic disease

 -  Presence of gross hematuria

 -  Presence of indwelling urologic foreign body (foley catheter, ureteral stent)

 -  Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast
 allergy)

 -  History of pelvic irradiation or malignancy

 -  Not a candidate for vaginal estrogen

 -  Allergy to vaginal estrogen

 -  Current or prior diagnosis of breast or endometrial cancer

 -  History of deep vein thrombosis/pulmonary embolus

 -  Hypercoagulable state