Clinical trial NCT03779633: Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: Local Oestrogen
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, Placebo-controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire)
timeFrame: change from baseline POP Score at 6 weeks after treatment
Secondary outcomes:
measure: operative time in minutes
timeFrame: up to 1 week postoperative
measure: length of stay in days
timeFrame: up to 1 week postoperative
measure: intraoperative blood loss in ml
timeFrame: up to 1 week postoperative
measure: blood circulation of the tissue (good, regular, scarce, no blood circulation)
timeFrame: on day of surgery
measure: separability of the tissue layers (good, regular, scarce, not possible)
timeFrame: on day of surgery
measure: easy separation from the bladder (yes/no)
timeFrame: on day of surgery
measure: easy opening of the Douglas cavity (Yes/no)
timeFrame: on day of surgery
measure: subjective (all domains of the pelvic floor questionnaire) outcome 3 months postoperative
timeFrame: 3 months postoperative
measure: objective (POP-Q score) outcome 3 months postoperative
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Tulln
country: Austria
facility: Department of Obstetrics and Gynecology, University of Tulln
city: Vienna
country: Austria
facility: Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.