Pharmacological Preparation of the Cervix for Hysteroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women

Conditions
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Endometrium; Senility, Uterine Polyp, Uterine Bleeding

Intervention / Treatment
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* Drug: estradiol
* Drug: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of endpoints in 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 (estradiol)<br>estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure | Drug: estradiol<br>* estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure<br>|
| Active Comparator: 2 (hyaluronic acid)<br>hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure | Drug: Hyaluronic acid<br>* hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure<br>|
| No Intervention: 3 (control)<br>no preparation of the cervix - arm without medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensification of pain during and after the procedure | Intensity of pain in Numeric Rating Scale (NRS: 0-10) | 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 | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical passage time | Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity | up to 6 months | 
| Occurrence of a vasovagal reaction | the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope) | 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 | up to 6 months |