Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

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.

Full Title of Study: “Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 11, 2023

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.

Interventions

  • 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.
  • Drug: Placebo Comparator: Postmenopausal, topical placebo cream
    • Postmenopausal participants randomized to topical vaginal placebo for about one month’s use prior to scheduled surgery.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Vaginal epithelial thickness
    • Time Frame: 1-month perioperative study
    • Measure of vaginal epithelial thickness obtained by optical coherence tomography

Secondary Measures

  • Histologic assessment of excised tissue
    • Time Frame: 1-month perioperative study
    • Evaluation of histology from surgery for collagen and elastin

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Medical Branch, Galveston
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathleen Vincent, MD, Principal Investigator, UTMB Galveston

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