Adenomyosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Those who have received a diagnosis of uterine adenomyosis through MRI testing. 2) Those who wish to preserve their fertility. 3) Those who are 18 years of age or older at the time of obtaining consent. 4) Those who are pre-menopausal and still experience regular menstrual cycles. 5) Those for whom existing drug therapy for uterine adenomyosis cannot be conducted or has not resulted in significant symptom improvement. 6) Those with a combined Menstrual Difficulty Score of 3 or higher. 7) Those who are suitable candidates for surgical removal of uterine adenomyosis lesions. 8) Those who have received adequate explanation about participation in this study, have a thorough understanding, and have provided written consent of their own free will.
Exclusion criteria
Exclusion criteria: 1) Those with Grade 3 or higher complications according to CTCAE v5.0. 2) Those with unexplained abnormal genital bleeding. 3) Those with indicated uterine malignancies requiring treatment. 4) Those who are pregnant or may be pregnant. 5) Those deemed unsuitable for participation in this study by the Principal Investigator or Co-Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of dysmenorrhea after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in pain score on the dysmenorrhea score at 3 and 9 months. 2) Change in pain medication usage score on the dysmenorrhea score at 3 and 9 months. 3) Complete disappearance rate of the dysmenorrhea score at 3 and 9 months. 4) Change in the total score of the dysmenorrhea score at 9 months. 5) Change in uterine volume on MRI. 6) Change in pain (NRS 0-10) at 3 and 9 months due to dysmenorrhea. 7) Change in pelvic pain (NRS 0-10) at 3 and 9 months due to adenomyosis. 8) Change in non-menstrual pelvic pain (NRS 0-10) at 3 and 9 months. 9) Change in MMAS at 3 and 9 months. 10) Surgical outcomes in adenomyomectomy (surgical time, blood loss, surgical complications, extent of adenomyosis lesion excision, and specimen weight). | — |
Contacts
The University of Tokyo Hospital