Health TrialsbyHealthPanel

Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

ConditionsAdenomyosisHysteroscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorFirst People's Hospital of Hangzhou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • A:hysteroscopic suture fixation of Mirena

    Procedure/Surgery

    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.

  • A: simple Mirena placement under hysteroscopy

    Procedure/Surgery

    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.

  • B: hysteroscopic suture fixation of Mirena

    Procedure/Surgery

    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.

  • B：simple Mirena placement under hysteroscopy

    Procedure/Surgery

    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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: the thickness of the thickest uterine myometrium ≥30mmOther 2 interventions
Group B: the thickness of the thickest uterine myometrium <30mmOther 2 interventions

Trial outcomes

Primary outcomes

1

expulsion rate of the Mirena

Time frame
1, 3, 6, and 12 months postoperatively

Secondary outcomes

1

menstrual volume

Time frame
1, 3, 6, and 12 months postoperatively
2

dysmenorrhea

Time frame
1, 3, 6, and 12 months postoperatively
3

uterine size under ultrasound

Time frame
1, 3, 6, and 12 months postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First People's Hospital of Hangzhou

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: