Adenomyosis
Conditions
Brief summary
to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms
Detailed description
Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics & Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch. Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1). Inclusion criteria: * Age Group: 30-50 years * Women with adenomyosis * With or without small fibroids * Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms. Exclusion criteria: * Presence of a malignancy or pelvic infection. * An on-going pregnancy or a desire to conceive in the future. * Absolute contraindication for angiography (renal impairment). * Chronic debilitating diseases.
Interventions
2 mg Dienogest orally
PROCEDUREUAE
under local anasthesia uterine artery embolizationwill be done
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
- Age Group: 30-50 years * Women with adenomyosis * With or without small fibroids * Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Exclusion criteria
* \- Presence of a malignancy or pelvic infection. * An on-going pregnancy or a desire to conceive in the future. * Absolute contraindication for angiography (renal impairment). * Chronic debilitating diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire | through study completion ,an average of 1 year | evaluation use of Dienogest versus uterine arteries embolization in improvement of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire |
Countries
Egypt
Contacts
Primary ContactAL-Azhar university Assuit
Outcome results
None listed