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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (estradiol) | Active Comparator | estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure |
|
| 2 (hyaluronic acid) | Active Comparator | hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure |
|
| 3 (control) | No Intervention | no preparation of the cervix - arm without medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estradiol | Drug | estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jach, Prof. | Jagiellonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University Medical College, Department of Gynecology and Obstetrics | Krakow | 31-501 | Poland |
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| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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).
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| Hyaluronic acid |
| Drug |
hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |