Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
Condition: Pelvic Organ Prolapse; Menopause
MeSH terms: Prolapse; Pelvic Organ Prolapse
Intervention: Premarin; Placebo
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pelvic organ prolapse; Menopause; Estrogen; Premarin

Summary:

      This is a study to determine how vaginal estrogen cream given for several weeks before pelvic
      reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the
      vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive
      either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At
      time of surgery, full thickness biopsies will be obtained from a standardized location at the
      top of vagina. The investigators will measure the thickness of the vaginal muscularis,
      elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is
      affected by estrogen therapy. The results will provide important data to support a larger
      clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term
      success rates of pelvic reconstructive surgery for pelvic organ prolapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women, still with uterus, planning total hysterectomy as part of surgical repair for
             pelvic organ prolapse

          -  Symptomatic anterior and/or apical vaginal prolapse greater than or equal to Stage 2
             (i.e., bulge extends to at least 1 cm of the hymen or beyond)

          -  Women between 1 and 10 years after menopause. Menopause is defined as one year of
             amenorrhea or surgical ovariectomy.

          -  Age 40-70 years old

          -  No estrogen replacement therapy in the last 1 month

          -  Physically capable of daily application of vaginal cream

        Exclusion Criteria:

          -  BMI >35

          -  Prior surgical repair of prolapse involving the vaginal cuff.

          -  Prior total hysterectomy

          -  Premenopausal or postmenopausal >10 years

          -  Prior steroid hormone replacement therapy of duration >1 month (oral or vaginal
             estrogen, testosterone or corticosteroids)

          -  History of connective tissue disease (Ehlers-Danlos, Marfan, etc)

          -  History of vaginal radiation

          -  Contraindications for estrogen replacement therapy (current, or history of,
             spontaneous deep vein thrombosis, stroke, coronary artery disease, breast or
             endometrial cancer)

          -  Concurrent use of steroid cream for treatment of Lichen sclerosis

          -  Recent history (within last month) of vaginal infection or vaginitis

          -  Current tobacco use