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
Overview
- Phase
- Phase 4
- Intervention
- Linoladiol Estradiol
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Medical University of Vienna
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Barbara Bodner-Adler
Clinical Professor
Medical University of Vienna
Eligibility Criteria
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
Arms & Interventions
Linoladiol Estradiol
Linoladiol Estradiol cream 6 weeks before surgery of pelvic organ prolapse
Intervention: Linoladiol Estradiol
Placebo
Placebo cream 6 weeks before surgery of pelvic organ prolapse
Intervention: Placebo vaginal cream
Outcomes
Primary Outcomes
subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire)
Time Frame: change from baseline POP Score at 6 weeks after treatment
treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire. 42 questions. Range 0 to 3 points for each question. Lower values represent a better outcome
Secondary Outcomes
- operative time in minutes(up to 1 week postoperative)
- length of stay in days(up to 1 week postoperative)
- intraoperative blood loss in ml(up to 1 week postoperative)
- blood circulation of the tissue (good, regular, scarce, no blood circulation)(on day of surgery)
- separability of the tissue layers (good, regular, scarce, not possible)(on day of surgery)
- easy separation from the bladder (yes/no)(on day of surgery)
- easy opening of the Douglas cavity (Yes/no)(on day of surgery)
- subjective (all domains of the pelvic floor questionnaire) outcome 3 months postoperative(3 months postoperative)
- objective (POP-Q score) outcome 3 months postoperative(3 months postoperative)