Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Postmenopausal, topical vaginal cream	Postmenopausal, topical vaginal estrogen cream	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.

Primary Outcome Measures

Name	Time	Method
Vaginal Epithelial Thickness	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).	Measure of vaginal epithelial thickness obtained by optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Histologic Assessment of Excised Tissue	1 month after visit 1 (3-17days after visit 2)	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)