Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

Launched by FIRST PEOPLE'S HOSPITAL OF HANGZHOU · Jun 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for placing a device called Mirena, which is used to treat a condition known as adenomyosis. Adenomyosis can cause painful symptoms like lower abdominal and back pain, as well as heavy menstrual bleeding. The trial will compare two methods: the standard way of placing Mirena and a new method that involves fixing it in place using a procedure called hysteroscopy. The goal is to see if the new method works just as well, or even better, and if it helps prevent the device from moving or falling out.

To be eligible for the trial, participants need to be premenopausal women aged 18 or older who experience significant pain from adenomyosis and have a specific size of uterus as confirmed by imaging tests like ultrasounds. They should also want to keep their uterus and not plan to get pregnant in the near future. If you join the study, you’ll receive care and monitoring throughout the process. This trial is not yet recruiting participants, but it aims to provide better treatment options for women suffering from adenomyosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;
• • Adenomyosis was confirmed by ultrasound or magnetic resonance imaging (MRI);
• • The uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ A strong desire to preserve the uterus; ⑤ No fertility requirements within nearly one year;
• • Premenopausal women aged ≥18 years old; ⑦ Willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain.
• Exclusion Criteria:
• • Presence of contraindications to Mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient);
• • Malignant tumors (including reproductive system and other systems);
• • Acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation;
• • The history of Mirena displacement or expulsion;
• • Ultrasound showed the presence of ovarian chocolate cyst; ⑥ The presence of deep endometrial nodules by gynecological examination;
• • The presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ Patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.