Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
Brief 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.


Options:
A: 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
B: Inclusion Criteria:

* Menopausal with absence of menstruation for at least 12 months
* Presence of vaginal atrophy symptoms \[subjective assessment of vaginal dryness \>7cm on VAS)
* Prolapse stage \< II, according to the pelvic organ prolapse quantification (POP-Q) system\[31\]
* No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included after 2 weeks)
* Understanding and acceptance of the obligation to return for all scheduled follow-up visits

Exclusion Criteria:

* Personal history of vulvovaginal condyloma,,vaginal intraepithelial neoplasia (VAIN), vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation
* Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida).
* Personal history of Scleroderma
* Any serious disease, or chronic condition, that could interfere with the study compliance
* Previously undergone reconstructive pelvic surgery within the past 6 months
* Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless current untreated exposure or extrusion)
* Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the study
* Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy
* Personal history of thrombophlebitis
* Personal history of heart failure or myocardial infarction within 12 months of procedure
* Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment
* Taking medications that are photosensitive
* Contraindication to Vaginal Estrogen Therapy
* Unwilling to Take Vaginal Estrogen
* Inability to give informed consent
C: Inclusion Criteria:

* genital dryness,
* irritation/burning/itching of vulvas or vagina
* decreased lubrication with sexual activity
* discomfort or pain with sexual activity
* decreased arousal, orgasm, desire
* dysuria.

Exclusion Criteria:

* previous surgeries for pelvic organ prolapse
* urinary incontinence
* usage of medication
* chronic medical illness
* body mass index (BMI) ≥ 35 kg/m2
* endometrial thickness equal to or greater than 4 mm
* abnormal uterine bleeding
* hormone-dependent malignancies
* history of thromboembolic disease
* liver disease
* usage of HT for less than 3 months
* usage of phytoestrogens within 1 month before the start of the study
* partner affected by sexual disorder
* conflicting with the partner
D: Inclusion Criteria:

* Women aged 45 years or older
* Postmenopausal (\>55 if natural menopause)
* Clinical atrophic vaginitis (at least mild atrophy)
* Pelvic organ prolapse(at least stage 2 or greater)
* Posthysterectomy
* Surgery date between 2-12 weeks after recruitment

Exclusion Criteria:

* Uterus present
* Well-estrogenized appearing vagina
* Known or suspected history of breast carcinoma
* Hormone-dependent tumor
* Genital bleeding of unknown cause
* Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
* Vaginal infection requiring treatment
* Allergy to estrogen or its constituents
* Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
* Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
* Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Answer: A