Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

Completed · Phase 4 · Has a placebo group

Conditions studied: Pelvic Organ Prolapse, Menopause

In brief

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.

Key facts

Study ID

NCT01778985

Run by

University of Texas Southwestern Medical Center

People needed

30

Starts

2012-12-01

Expected to finish

2013-04-01

Last updated by the study team

2014-10-02

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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