Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse|
- Composite of vaginal wall inflammatory markers and macrocirculatory and microcirculatory flow on pelvic floor dysfunction [ Time Frame: 1-month perioperative study ] [ Designated as safety issue: No ]
- Composite of tissue matrix metalloproteinases, collagen/elastin structure, microvasculature and muscle thickness [ Time Frame: 1-month perioperative study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Postmenopausal, topical vaginal cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery.
Drug: Topical Vaginal Estrogen Cream/placebo
Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
Other Name: Premarin, Estrace
|No Intervention: Pre-menopausal, no topical vaginal cream|
|Contact: Carrie Derkowski, BSfirstname.lastname@example.org|
|United States, Texas|
|UTMB Speciality Care Center at Victory Lakes||Recruiting|
|League City, Texas, United States, 77573|
|Contact: Tristi Muir, MD 409-747-6625 email@example.com|
|Principal Investigator: Kathleen L Vincent, MD|
|Sub-Investigator: Erin Conroy, MD|
|Principal Investigator:||Tristi Muir, MD||UTMB Galveston|