Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor (PET)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Menopause; Pelvic Organ Prolapse

Treatments: Drug: Premarin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01778985

STU-042011-101

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Premarin

Experimental group

Description:

Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Treatment:

Drug: Premarin

Placebo

Placebo Comparator group

Description:

Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Treatment:

Other: Placebo