Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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