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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Linoladiol Estradiol Initial dose (week 1): 1 application (2g Linoladiol = 0.2mg Estradiol) every day for the first week Maintenance dose 1 (week 2) : 1 application (2g Linoladiol = 0.2mg Estradiol) every 48 hours the following week. Maintenance dose 2 (week 3-6): 1 application (2g Linoladiol = 0.2mg Estradiol) twice per week the following 4 weeks. Route of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks
Initial dose (week 1): 1 application every day for the first week Maintenance dose 1 (week 2) : 1 application every 48 hours the following week. Maintenance dose 2 (week 3-6): 1 application twice per week the following 4 weeks. Route of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks
Department of Obstetrics and Gynecology, University of Tulln
Tulln, Austria
Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna
Vienna, Austria
subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire)
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
Time frame: change from baseline POP Score at 6 weeks after treatment
operative time in minutes
effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo
Time frame: up to 1 week postoperative
length of stay in days
effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo
Time frame: up to 1 week postoperative
intraoperative blood loss in ml
effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo
Time frame: up to 1 week postoperative
blood circulation of the tissue (good, regular, scarce, no blood circulation)
differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
Time frame: on day of surgery
separability of the tissue layers (good, regular, scarce, not possible)
differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
Time frame: on day of surgery
easy separation from the bladder (yes/no)
differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
Time frame: on day of surgery
easy opening of the Douglas cavity (Yes/no)
differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation
Time frame: on day of surgery
subjective (all domains of the pelvic floor questionnaire) outcome 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.
Time frame: 3 months postoperative
objective (POP-Q score) outcome 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).
Time frame: 3 months postoperative
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