Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse

NCT03779633 | Completed Phase 4 DMC

• 1 other identifier: EstrogenPOP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Organ Prolapse

Keywords

Local Oestrogen

Outcome Measures

Primary Outcomes (1)

• 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

  change from baseline POP Score at 6 weeks after treatment

Secondary Outcomes (9)

• 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

Study Arms (2)

Linoladiol Estradiol

EXPERIMENTAL

Linoladiol Estradiol cream 6 weeks before surgery of pelvic organ prolapse

Drug: Linoladiol Estradiol

Placebo

PLACEBO COMPARATOR

Placebo cream 6 weeks before surgery of pelvic organ prolapse

Other: Placebo vaginal cream

Interventions

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

Also known as: Montavit ATC Code G03CA03

Linoladiol Estradiol

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Department of Obstetrics and Gynecology, University of Tulln

Tulln, 3430, Austria

Location

Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna

Vienna, 1090, Austria

Location

Related Publications (4)

• 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.

  PMID: 26383760 BACKGROUND

• 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.

  PMID: 24947034 BACKGROUND

• 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.

  PMID: 37431855 DERIVED

• 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.

  PMID: 35443258 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Double-blind, Placebo-controlled

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: December 19, 2018
• Study Start: February 2, 2017
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

AU (2)