Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
NCT ID: NCT03779633
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2017-02-02
2020-08-27
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Linoladiol Estradiol
Linoladiol Estradiol cream 6 weeks before surgery of pelvic organ prolapse
Linoladiol Estradiol
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
Placebo
Placebo cream 6 weeks before surgery of pelvic organ prolapse
Placebo vaginal cream
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
Interventions
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Linoladiol Estradiol
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
Placebo vaginal cream
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Barbara Bodner-Adler
Clinical Professor
Locations
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Department of Obstetrics and Gynecology, University of Tulln
Tulln, , Austria
Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna
Vienna, , Austria
Countries
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References
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Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PLoS One. 2015 Sep 18;10(9):e0136265. doi: 10.1371/journal.pone.0136265. eCollection 2015.
Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, Word RA. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3728-36. doi: 10.1210/jc.2014-1216. Epub 2014 Jun 20.
Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available.
Other Identifiers
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EstrogenPOP
Identifier Type: -
Identifier Source: org_study_id