Vaginal Estrogen for Asymptomatic Microscopic Hematuria

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The specific aim of this protocol is to determine whether vaginal estrogen is an effective treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators hypothesize that women who use vaginal estrogen for three months will be more likely to have resolution of their asymptomatic microscopic hematuria compared with women who do not use vaginal estrogen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Urogynecology Associates
• Collaborators: Beth Israel Deaconess Medical Center; Mount Auburn Hospital
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal, defined by amenorrhea for at least one year or a bilateral oophorectomy at least one year prior, and have three or more red blood cells per high powered field visible in a properly collected urine specimen without evidence of infection. In addition, women must have a negative cystoscopy and computed tomography urogram (or magnetic resonance urography if history of renal insufficiency or contrast allergy) within the past three years.

Exclusion Criteria:

• Current or past thromboembolic disorder or cerebrovascular accident

• Intolerance to previous estrogen replacement therapy or hormone replacement therapy

• Estrogen dependent neoplasm within the past five years (unless supporting documentation from patient's oncologist is obtained)

• Estrogen replacement therapy or hormone replacement therapy within the past three months or selective estrogen receptor modulators within eight weeks of enrollment

• Urinary tract infection

• Urinary calculi

• Urinary tract malignancy

• Vaginal bleeding of unknown origin

• Urethral caruncle

• History of recurrent urinary tract infections in the last one year

• Stage two or greater pelvic organ prolapse.