Endometrium; Senility, Uterine Bleeding, Uterine Polyp
Conditions
Brief summary
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
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).
Interventions
DRUGestradiol
estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
DRUGHyaluronic acid
hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
Sponsors
Jagiellonian University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensification of pain during and after the procedure | up to 6 months | Intensity of pain in Numeric Rating Scale (NRS: 0-10) |
| The need of cervical dilation | up to 6 months | The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical passage time | up to 6 months | Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity |
| Occurrence of a vasovagal reaction | up to 6 months | the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope) |
| Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact) | up to 6 months | Clinical evaluation of the occurrence of symptoms of urogenital atrophy |
Countries
Poland
Outcome results
None listed