Clinical trial NCT06478992: Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
Official title: A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adenomyosis
Hysteroscopy
Keywords: Suture fixation
Expulsion
Mirena
Adenomyosis
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.

Detailed description: This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.

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.

Primary outcomes:
measure: expulsion rate of the Mirena
timeFrame: 1, 3, 6, and 12 months postoperatively
Secondary outcomes:
measure: menstrual volume
timeFrame: 1, 3, 6, and 12 months postoperatively
measure: dysmenorrhea
timeFrame: 1, 3, 6, and 12 months postoperatively
measure: uterine size under ultrasound
timeFrame: 1, 3, 6, and 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References: