Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02213757
Status:
TERMINATED
Last Update Posted:
2023-03-15
First Post:
2014-08-08
Brief Title:
Effect of Vaginal Estrogen on Asymptomatic Microhematuria AMH
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Effect of Vaginal Estrogen on Asymptomatic Microhematuria AMH A Randomized Controlled Trial EVER Study
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVER
Brief Summary:
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
Detailed Description:
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 0625mg 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 contrast1
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
Women meeting inclusion criteria will be randomized to either conjugated equine estrogen cream Premarin 0625mg 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 contrast1
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None