Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Phase 4TerminatedNCT01886794

The University of Texas Medical Branch, Galveston7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Pelvic Floor Disorders

Interventions

Postmenopausal, topical vaginal estrogen creamDRUG

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.

Placebo Comparator: Postmenopausal, topical placebo creamDRUG

Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

UTMB Galveston

Galveston, Texas, United States

Outcomes

Primary Outcomes

Vaginal Epithelial Thickness

Measure of vaginal epithelial thickness obtained by optical coherence tomography

Time frame: Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart).

Secondary Outcomes

Histologic Assessment of Excised Tissue

Evaluated tissue samples obtained during surgery to examine collagen. Collagen score (Masson trichrome): 3=abundant collagen (dark blue stain), 2=collagen present (light blue stain), 1=scant collagen (minimal blue stain) Higher scores indicate more collagen, or better outcome. (note that study vaginal drug was stopped at visit 2 for postmenopausal subjects except in one subject who used active topical vaginal cream but stopped after 2 weeks due to AE. Her OCT score was obtained after 2 weeks of active cream, however the histology was obtained 2 weeks after discontinuation of study drug because Visit 2 was scheduled at the time of the AE and at the time of stopping the active cream. The OCT and histology results are not concordant due to being taken at different timepoints (visit 2 on active cream vs surgery 16 days later off cream)

Time frame: 1 month after visit 1 (3-17days after visit 2)

Data from ClinicalTrials.gov

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