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

TriHealth Inc.54 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse Vaginal Atrophy

Interventions

Vaginal conjugated estrogen cream 0.5gmDRUG

Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

Vaginal conjugated estrogen cream 1.0gmDRUG

Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and 2-12 weeks after treatment (at time of surgery)

Secondary Outcomes

Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.

Time frame: baseline and 2-12 weeks after treatment (at time of surgery)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.