Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse

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.

Study Overview

• Status: Terminated
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Drug: Postmenopausal, topical vaginal estrogen cream; Drug: Placebo Comparator: Postmenopausal, topical placebo cream

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • UTMB Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postmenopausal, topical vaginal 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.	Drug: Postmenopausal, topical vaginal estrogen cream; 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.; Other Names: Estrace vaginal cream
No Intervention: Pre-menopausal, no topical vaginal cream; Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
Placebo Comparator: Postmenopausal, topical placebo 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 placebo.	Drug: Placebo Comparator: Postmenopausal, topical placebo cream; Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.; Other Names: Placebo vaginal cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Epithelial Thickness	Measure of vaginal epithelial thickness obtained by optical coherence tomography	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 month after visit 1 (3-17days after visit 2)

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Kathleen Vincent, MD, UTMB Galveston

Publications and helpful links

Helpful Links

• Link to the clinic where recruitment will be performed

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2013
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimated): June 26, 2013

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; pelvic floor dysfunction; vaginal estrogen effects
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Pelvic Floor Disorders; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens
• Other Study ID Numbers: 13-114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No