Pharmacological Preparation of the Cervix for Hysteroscopy

Jagiellonian University96 enrolled

Overview

Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.

A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Polyp Uterine Bleeding Endometrium; Senility

Interventions

estradiolDRUG

estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure

Hyaluronic acidDRUG

hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 45-90 years * uterine cavity focal lesion, abnormal uterine bleeding Exclusion Criteria: * drug allergy * no consent to the procedure or participation in the study

Locations (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, Poland

Outcomes

Primary Outcomes

Intensification of pain during and after the procedure

Intensity of pain in Numeric Rating Scale (NRS: 0-10)

Time frame: up to 6 months

The need of cervical dilation

The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity

Time frame: up to 6 months

Secondary Outcomes

Cervical passage time

Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity

Time frame: up to 6 months

Occurrence of a vasovagal reaction

the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)

Time frame: up to 6 months

Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)

Clinical evaluation of the occurrence of symptoms of urogenital atrophy

Time frame: up to 6 months

Data from ClinicalTrials.gov

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