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Vaginal Estrogen for Asymptomatic Microscopic Hematuria

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ClinicalTrials.gov Identifier: NCT03033160
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Mount Auburn Hospital
Information provided by (Responsible Party):
Lekha S. Hota, Boston Urogynecology Associates

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.

Condition or disease Intervention/treatment Phase
Asymptomatic Microscopic Hematuria Drug: Estradiol Ring Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Vaginal Estrogen to Treat Asymptomatic Microscopic Hematuria
Study Start Date : December 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: Estradiol Ring
Estradiol Ring per vagina every 3 months
Drug: Estradiol Ring
Other Name: Estring

No Intervention: Observation
Observation



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033160


Contacts
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Contact: Kathleen Rogers 614-354-5452 krogers2@mah.harvard.edu

Locations
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United States, Massachusetts
Mount Auburn Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathleen Rogers    617-354-5452    krogers2@mah.harvard.edu   
Sponsors and Collaborators
Boston Urogynecology Associates
Beth Israel Deaconess Medical Center
Mount Auburn Hospital
Investigators
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Principal Investigator: Lekha Hota, MD Practitioner
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Responsible Party: Lekha S. Hota, Clinical Instructor Division of Urogynecology and Female Pelvic Medicine and Reconstructive Surgery, Boston Urogynecology Associates
ClinicalTrials.gov Identifier: NCT03033160    
Other Study ID Numbers: 052-2015
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lekha S. Hota, Boston Urogynecology Associates:
Estrogen
Hematuria
Additional relevant MeSH terms:
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Hematuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs