Pelvic Organ Prolapse, Vaginal Atrophy
Conditions
Keywords
pelvic organ prolapse, vaginal atrophy, atrophic vaginitis, postmenopausal, posthysterectomy, vaginal health, vaginal cytology, vaginal maturity index, vaginal histology, quality of life questionnaires
Brief summary
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
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
Interventions
DRUGVaginal conjugated estrogen cream 0.5gm
Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
DRUGVaginal conjugated estrogen cream 1.0gm
Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
United States
Outcome results
None listed