Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
Status:
Completed
Trial end date:
2020-08-27
Target enrollment:
Participant gender:
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.