Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse

Conditions
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Pelvic Floor Disorders

Intervention / Treatment
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* Drug: Postmenopausal, topical vaginal estrogen cream
* Drug: Placebo Comparator: Postmenopausal, topical placebo cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postmenopausal, topical vaginal cream<br>Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream. | Drug: Postmenopausal, topical vaginal estrogen cream<br>* 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.<br>* Other names: Estrace vaginal cream;|
| No Intervention: Pre-menopausal, no topical vaginal cream<br>Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. | |
| Placebo Comparator: Postmenopausal, topical placebo cream<br>Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. | Drug: Placebo Comparator: Postmenopausal, topical placebo cream<br>* Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.<br>* Other names: Placebo vaginal cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal epithelial thickness | Measure of vaginal epithelial thickness obtained by optical coherence tomography | 1-month perioperative study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic assessment of excised tissue | Evaluation of histology from surgery for collagen and elastin | 1-month perioperative study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor dysfunction, pelvic organ prolapse, vaginal estrogen effects