Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Drug: Linoladiol EstradiolOther: Placebo vaginal cream
- Registration Number
- NCT03779633
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linoladiol Estradiol Linoladiol Estradiol Linoladiol Estradiol cream 6 weeks before surgery of pelvic organ prolapse Placebo Placebo vaginal cream Placebo cream 6 weeks before surgery of pelvic organ prolapse
- Primary Outcome Measures
Name Time Method subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire) 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 Outcome Measures
Name Time Method operative time in minutes up to 1 week postoperative effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo
length of stay in days up to 1 week postoperative effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo
intraoperative blood loss in ml up to 1 week postoperative effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo
blood circulation of the tissue (good, regular, scarce, no blood circulation) on day of surgery differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
separability of the tissue layers (good, regular, scarce, not possible) on day of surgery differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
easy separation from the bladder (yes/no) on day of surgery differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
easy opening of the Douglas cavity (Yes/no) on day of surgery differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
subjective (all domains of the pelvic floor questionnaire) outcome 3 months postoperative 3 months postoperative possible differences regarding subjective outcome parameters between intervention and placebo-group 3 months after operation. 42 questions. Range 0 to 3 points for each question. Lower values represent a better outcome.
objective (POP-Q score) outcome 3 months postoperative 3 months postoperative possible differences regarding objective outcome parameters between intervention and placebo-group 3 months after operation. POP-Q Score (Score between 0 and 4). The POP- quantification system consists of six defined points of measurement (Aa, Ba, C,D,Ap,Bp) and three other landmarks (GH,TVL, PB). Each is measured in centimeters above the hymen (negative number) or below the hymen (positive number).
Trial Locations
- Locations (2)
Department of Obstetrics and Gynecology, University of Tulln
🇦🇹Tulln, Austria
Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna
🇦🇹Vienna, Austria