Clinical Trial: Vaginal Estrogen for Asymptomatic Microscopic Hematuria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial of Vaginal Estrogen to Treat Asymptomatic Microscopic Hematuria

Brief 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.

Detailed Summary:

This is a multi-center, randomized controlled trial to evaluate whether vaginal estrogen is an effective treatment for asymptomatic microscopic hematuria. Postmenopausal women with asymptomatic microscopic hematuria will be recruited from the two urogynecology clinics that serve as the clinic sites for the Mount Auburn Hospital/Beth Israel Deaconess Medical Center Female Pelvic Medicine and Reconstructive Surgery fellowship.

Participants are eligible if they are 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, participants 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 include any of the following: 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, and stage two or greater pelvic organ prolapse.

Participants will be randomized to either an estradiol-releasing vaginal ring (Estring; Pfizer, New York, NY) or expectant management in a ratio of 1:1 using computer-generated block randomiza
Sponsor: Boston Urogynecology Associates

Current Primary Outcome: Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement [ Time Frame: 12 weeks ]

Investigators will compare red blood cell count results obtained during the initial urinalysis to the 12 week urinalysis to measure any change in red blood cell count (if any).


Original Primary Outcome:

  • Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement [ Time Frame: 12 weeks ]
    Investigators will compare red blood cell count results obtained during the initial urinalysis to the 12 week urinalysis to measure any change in red blood cell count (if any).
  • comparison of microscopic hematuria (RBC's) at 24 weeks compared to baseline [ Time Frame: 24 weeks ]
    Investigators will compare red blood cell count results obtained during the initial urinalysis to the 24 week urinalysis to measure any change in red blood cell count (if any).


Current Secondary Outcome:

  • Comparison of Microscopic Hematuria (RBC's) at 24 weeks compared to baseline. [ Time Frame: 24 weeks ]
    Investigators will cimpare red blood cell count results obtained during the initial Urinalysis to the 24 week urinalysis to measure any change in red blood cell count (if any).
  • To Assess Quality of Life [ Time Frame: 12 weeks ]
    Measurement of quality of life change from baseline, utilizing subject self administered questionnaires, Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire-short Form (IIQ-7)


Original Secondary Outcome: Quality of Life [ Time Frame: 12 weeks ]

Measurement of quality of life change from baseline


Information By: Boston Urogynecology Associates

Dates:
Date Received: October 19, 2016
Date Started: December 2016
Date Completion: December 30, 2020
Last Updated: February 15, 2017
Last Verified: February 2017