Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse



Status:Recruiting
Healthy:No
Age Range:21 - 70
Updated:1/9/2019
Start Date:June 2013
End Date:December 2021
Contact:Lauren Dawson, BS
Email:lndawson@utmb.edu
Phone:409-354-9792

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Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With 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.

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. We will
perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and
overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for
histologic and imaging analysis.

Inclusion Criteria:

- 21 to 70 years of age

- Stage II or greater pelvic organ prolapse (POP)

- Individuals electing surgery to treat their POP

- Willing and able to comply with study procedures

- Willing and able to provide written informed consent

Exclusion Criteria:

- Contraindication for estrogen cream

- Any medical condition that in the opinion of the investigator would place the subject
at increased risk for participation

- History of connective tissue disease

- Previous hysterectomy or pelvic organ prolapse surgery

- Known allergic reaction to any agent required by the protocol

- Use of hormone therapy in postmenopausal women in the last 90 days

- Pregnant or lactating females

- History of prior noncompliance or the presence or history of psychiatric condition
that would in the opinion of the investigator make it difficult for the subject to
comply with study procedures or follow instructions
We found this trial at
1
site
League City, Texas 77573
Principal Investigator: Kathleen L Vincent, MD
Phone: 409-747-6625
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from
League City, TX
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