Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

NCT06478992 | Not Yet Recruiting

• 1 other identifier: IIT-20220610-0097-02
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adenomyosis; Hysteroscopy

Keywords

Suture fixation; Expulsion; Mirena; Adenomyosis

Outcome Measures

Primary Outcomes (1)

• expulsion rate of the Mirena

  1, 3, 6, and 12 months postoperatively

Secondary Outcomes (3)

• menstrual volume

  1, 3, 6, and 12 months postoperatively

• dysmenorrhea

  1, 3, 6, and 12 months postoperatively

• uterine size under ultrasound

  1, 3, 6, and 12 months postoperatively

Study Arms (2)

the thickness of the thickest uterine myometrium ≥30mm

OTHER

Procedure: A:hysteroscopic suture fixation of Mirena; Procedure: A: simple Mirena placement under hysteroscopy

the thickness of the thickest uterine myometrium <30mm

OTHER

Procedure: B: hysteroscopic suture fixation of Mirena; Procedure: B：simple Mirena placement under hysteroscopy

Interventions

A:hysteroscopic suture fixation of Mirena PROCEDURE

A(the thickness of the thickest uterine myometrium ≥30mm ):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

the thickness of the thickest uterine myometrium ≥30mm

A: simple Mirena placement under hysteroscopy PROCEDURE

A(the thickness of the thickest uterine myometrium ≥30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

the thickness of the thickest uterine myometrium ≥30mm

B: hysteroscopic suture fixation of Mirena PROCEDURE

B(the thickness of the thickest uterine myometrium\<30mm):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

the thickness of the thickest uterine myometrium <30mm

B：simple Mirena placement under hysteroscopy PROCEDURE

B(the thickness of the thickest uterine myometrium\<30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

the thickness of the thickest uterine myometrium <30mm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: June 30, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06