Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preoperative Locally Applied Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse: Changes in Subjective and Objective Outcome - a Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study
Brief Summary: Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alone or in combination with other forms of therapy, may assist in the management of POP by increasing collagen synthesis and thereby improving the strength of the weakened vaginal epithelium. Yet, studies investigating the effect of topical oestrogen and its impact on POP associated symptoms, both self-reported improvement and observations of objective improvement, are lacking.

Objective To evaluate the subjective efficacy concerning prolapse associated complaints measured by the German pelvic floor questionnaire (domain POP: POP-score) after preoperative use of local oestrogen compared to preoperative placebo treatment in postmenopausal women with symptomatic pelvic organ prolapse. Further variables of interest are POP-score after 3 months, differences regarding the objective prolapse quantification system (POP-Q), surgical outcome and tissue operability assessed by the surgeon.

Methods In this prospective, randomized, double-blind, placebo-controlled, multicenter study the investigators aim to include 120 postmenopausal women with symptomatic pelvic organ prolapse and indicated operative procedure. An analysis of covariance will be computed with the depending variable POP-score after 6 weeks and the independent variables group (verum versus placebo) and Pop-Score at baseline.


Options:
A: Inclusion Criteria:

* Females with POP who have opted for conservative management with a pessary
* Able to read and write English
* First time pessary users
* Successful fitting with a covered ring or Gellhorn pessary, as determined at the usual early follow-up visit 2-4 weeks after initial fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
* Patients agree to use vaginal estrogen (either tablet or cream twice weekly) during the study period; patients may not use a vaginal estrogen ring since this requires changing every 3 months, and will interfere with the study follow-up schedule

Exclusion criteria:

* Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection
* Significant cognitive impairment
* Pessary used for indication other than POP (ie. urinary incontinence)
* Use of a pessary that is not a covered ring or Gellhorn (i.e exclude cube, donut, etc.)
* Contraindications to vaginal estrogen
* Unsuccessful pessary fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
B: Inclusion Criteria:

* Female
* Indications for initiation of pessary use and planning to be fitted for and wear a pessary

Exclusion Criteria:

* Male
* Already using a pessary or have used in the last year
* History of recurrent or chronic bacterial vaginosis with \> 2 episodes per year or symptoms reported for \> 6 months out of last year
* Active known vaginal infection (symptomatic and/or untreated) or completion of treatment for BV or cervical/vaginal infection within one week of recruitment
* History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment, or HSV with \> 2 outbreaks per year or last outbreak \< 1 month ago)
* Chronic antibiotic use for indications not listed above
C: Inclusion Criteria:

* Postmenopausal women
* Able to read, understand and sign informed consent
* Able to apply a vaginal cream
* Symptomatic pelvic organ prolapse with planned and indicated prolapse surgical repair

Exclusion Criteria:

* Suspicion or history of breast cancer or other oestrogen responsive malignancies (endometrial cancer)
* unexplained abnormal vaginal bleeding
* history of deep vein thrombosis
* inherited or acquired blood clotting disorders (eg, APC resistance, Antithrombin III deficiency)
* transient ischaemic attack, myo- cardial infarction or ischaemic heart disease
* Hypersensitivity to oestrogen
* Unable to read and sign informed consent
D: Inclusion Criteria:

* post menopause women
* normal oncotic cytology and mammogram
* any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm

Exclusion Criteria:

* vaginal bleeding
* hormonal replacement on the past three months
* renal or hepatic desease
* porfiria
* past venous thromboembolism; ulcerated prolapse

Answer: C