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Completed

NCT Number: NCT03779633

Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics and Gynecology, University of Tulln, Tulln, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linoladiol Estradiol

Drug

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

Other names: Montavit ATC Code G03CA03

Placebo vaginal cream

Other

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

Primary outcomes

  1. 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

  1. operative time in minutes

    Time frame: up to 1 week postoperative

    effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo

  2. length of stay in days

    Time frame: up to 1 week postoperative

    effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo

  3. intraoperative blood loss in ml

    Time frame: up to 1 week postoperative

    effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo

  4. blood circulation of the tissue (good, regular, scarce, no blood circulation)

    Time frame: 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

  5. separability of the tissue layers (good, regular, scarce, not possible)

    Time frame: 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

  6. easy separation from the bladder (yes/no)

    Time frame: 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

  7. easy opening of the Douglas cavity (Yes/no)

    Time frame: 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

  8. subjective (all domains of the pelvic floor questionnaire) outcome 3 months postoperative

    Time frame: 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.

  9. objective (POP-Q score) outcome 3 months postoperative

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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