Please select the arm or intervention descriptions that belong 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: Arm Label: Pessary Check at 3 months; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 6 month Pessary Check; Type: EXPERIMENTAL; Interventions: Other: 6 month follow up for pessary check in the clinic setting | Intervention Type: OTHER; Name: 6 month follow up for pessary check in the clinic setting; Assigned to Arm(s): 6 month Pessary Check
B: Arm Label: Trimo-San group; Type: EXPERIMENTAL; Interventions: Drug: Trimo-San gel | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Trimo-San gel; Assigned to Arm(s): Trimo-San group
C: Arm Label: Linoladiol Estradiol; Type: EXPERIMENTAL; Interventions: Drug: Linoladiol Estradiol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo vaginal cream | Intervention Type: DRUG; Name: Linoladiol Estradiol; Assigned to Arm(s): Linoladiol Estradiol | Intervention Type: OTHER; Name: Placebo vaginal cream; Assigned to Arm(s): Placebo
D: Arm Label: Conjugated Estrogen Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Promestriene, Drug: Estriol, Drug: Vaginal Moisturizer - Cream | Arm Label: Promestriene Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Conjugated Estrogen, Drug: Estriol, Drug: Vaginal Moisturizer - Cream | Arm Label: Estriol Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Conjugated Estrogen, Drug: Promestriene, Drug: Vaginal Moisturizer - Cream | Arm Label: Vaginal Moisturizer Cream; Type: PLACEBO_COMPARATOR; Interventions: Drug: Conjugated Estrogen, Drug: Promestriene, Drug: Estriol | Intervention Type: DRUG; Name: Conjugated Estrogen; Assigned to Arm(s): Estriol Group, Promestriene Group, Vaginal Moisturizer Cream | Intervention Type: DRUG; Name: Promestriene; Assigned to Arm(s): Conjugated Estrogen Group, Estriol Group, Vaginal Moisturizer Cream | Intervention Type: DRUG; Name: Estriol; Assigned to Arm(s): Conjugated Estrogen Group, Promestriene Group, Vaginal Moisturizer Cream | Intervention Type: DRUG; Name: Vaginal Moisturizer - Cream; Assigned to Arm(s): Conjugated Estrogen Group, Estriol Group, Promestriene Group

Answer: C