Please select the eligibility criteria that correspond to the clinical trial below.
Title: Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Brief Summary: This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.


Options:
A: Inclusion Criteria:

Women:

* who are new attendees at outpatient gynaecology clinics with a primary complaint of prolapse;
* who have a prolapse of stage I to IV confirmed by their gynaecologist using the POP-Q grading system;
* who have a prolapse of one or more of the following types:
* anterior vaginal wall prolapse (urethrocele, cystocele,paravaginal defect);
* uterine/cervical prolapse;
* vaginal vault (after hysterectomy)prolapse;
* posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency);
* who require a vaginal pessary for treatment of their prolapse (the process of fitting the pessary will be according to standard practice at the centre thus the protocol for choice of pessary, insertion and follow-up will be determined locally);
* who successfully retain the vaginal pessary for two weeks after fitting;
* who are willing to participate in the study and to comply with their group allocation.

Exclusion Criteria:

Women:

* who wish surgical treatment for prolapse and wish to be immediately added to the surgical waiting list;
* who have had previous surgical treatment for prolapse;
* who have had a pessary fitted for treatment of prolapse within the last 12 months;
* who have had previous formal instruction in PFMT;
* who present with contraindications to either pessary or PFMT treatment;
* who are unable to comply with PFMT treatment;
* who have local atrophy (this must be treated first);
* who are less than 6-months postnatal;
* who are pregnant;
* who are unable to give informed consent.
B: 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)
C: Inclusion Criteria:

* Postmenopausal: no menses for \>1 year
* Minimum age: 48 years
* Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
* No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
* Medically fit for elective surgery
* Physically able to apply/insert the study drug
* Available for clinic follow-up for minimum 1yr

Exclusion Criteria:

* Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
* BMI \>35 kg/m2
* Recent history (within last month) of vaginal infection or vaginitis
* Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
* History of connective tissue disease
* Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
* History of vaginal irradiation
* Allergy to Premarin or its constituents
* Prior apical repair or use of mesh for prolapse repair
* Current tobacco use
D: Inclusion Criteria:

* Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.

Exclusion Criteria:

* have a contraindication to the use of estrogen cream or products
* have any allergy to the use of estrogen cream or products
* have a past medical or family history of breast cancer
* have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
* have previously used Premarin vaginal cream
* are currently using oral estrogen
* are not competent to consent

Answer: C