Purpose

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.

Condition

Eligibility

Eligible Ages
Between 21 Years and 70 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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 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:
    • Premarin
    • Estrace
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.

Recruiting Locations

UTMB Speciality Care Center at Victory Lakes
League City, Texas 77573
Contact:
Tristi Muir, MD
409-747-6625
trmuir@utmb.edu

More Details

NCT ID
NCT01886794
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Lauren Dawson, BS
409-354-9792
lndawson@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.