The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse

Study Overview
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Brief Summary
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The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Detailed Description
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Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.

Official Title
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The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

Conditions
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Pelvic Organ Prolapse, Vaginal Atrophy

Intervention / Treatment
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* Drug: Vaginal conjugated estrogen cream 0.5gm
* Drug: Vaginal conjugated estrogen cream 1.0gm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 45 years or older Postmenopausal (>55 if natural menopause) Clinical atrophic vaginitis (at least mild atrophy) Pelvic organ prolapse(at least stage 2 or greater) Posthysterectomy Surgery date between 2-12 weeks after recruitment Exclusion Criteria: Uterus present Well-estrogenized appearing vagina Known or suspected history of breast carcinoma Hormone-dependent tumor Genital bleeding of unknown cause Acute thrombophlebitis or thromboembolic disorder associated with estrogen use Vaginal infection requiring treatment Allergy to estrogen or its constituents Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance. Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Ages Eligible for Study
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Minimum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Premarin cream 0.5gm<br>Application of 0.5gm of vaginal estrogen cream nightly until surgery. | Drug: Vaginal conjugated estrogen cream 0.5gm<br>* Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.<br>* Other names: Premarin;|
| Active Comparator: Premarin cream 1.0gm<br>Application of 1.0gm of vaginal estrogen cream nightly until surgery. | Drug: Vaginal conjugated estrogen cream 1.0gm<br>* Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.<br>* Other names: Premarin;|
| No Intervention: No intervention<br>Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. |  | baseline and 2-12 weeks after treatment (at time of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology. |  | baseline and 2-12 weeks after treatment (at time of surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, vaginal atrophy, atrophic vaginitis, postmenopausal, posthysterectomy, vaginal health, vaginal cytology, vaginal maturity index, vaginal histology, quality of life questionnaires