Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms (MUSA 3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Association between MUSA defined ultrasound features of adenomyosis and the severity of clinical symptoms.
研究概览
简要总结
The goal of this study/research is to assess the relationship between ultrasound features of the myometrium suggestive of adenomyosis and clinical symptoms of adenomyosis and to establish a reporting system for adenomyosis assessing disease severity. Consecutive pre- and perimenopausal symptomatic and asymptomicasymptomatic women with an uterus presenting for gynaecological ultrasound exams will be asked to participate in the study. Routine gynecologicalgynaecological ultrasound exams will be performed and study participants will fill out a questionnaire on their symptoms (if any) and bleeding pattern. There will be one visit and no interventions.
详细描述
In adenomyosis endometrial tissue is embedded in the myometrium of the uterus. It is considered a relevant benign, underreported disease of the uterus and is a frequent cause of dysmenorrhea, bleeding disorders and abdominal pain and subfertility. The reference standard for diagnosis is histology, but the majority of women will have hormonal medical treatment, are in the reproductive age and will not undergo surgery (i.e. hysterectomy). Today ultrasound has become the first line imaging method for diagnosis.
The proportion of women that show ultrasound features of adenomyosis without symptoms is unknown but a third of young, nulliparous women without other associated disease will show signs of adenomyosis.
The MUSA consensus describes ultrasound features suggestive of adenomyosis: asymmetrical thickening of the myometrium, cysts within the myometrium, echogenic subendometrial lines and buds, hyperechoic islands, fan shaped shadowing and an irregular or interrupted junctional zone. More recently the MUSA criteria have been specified further and now distinguish between direct features, that are typical for adenomyosis and indirect features that result from ectopic endometrium in the myometrium.
This is a cross sectional exploratory non-interventional observational multicenter study with one visit and no interventions with assessment of participant demographics, standardized assessment of bleeding, standardized assessment of pain, standardized ultrasound exam.
The primary objective of the study is to assess the relationship between MUSA-defined ultrasound features of the myometrium suggestive of adenomyosis and the severity of clinical symptoms, specifically pain (NRS) and abnormal uterine bleeding (PBAC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent.
- •Symptomatic and asymptomatic women
- •Patients with hormonal contraceptives and Hormone Replacement Therapy (HRT) can be included, but information will be noted.
排除标准
- •Missing written consent (study consent)
- •Any serious underlying medical, psychiatric or psychological condition, which may interfere with the patient's capacity of discernment.
- •Postmenopausal women
- •Pregnancy
- •History of pelvic urogynaecologic surgery (TVT, mesh surgery, etc.)
- •Malignancy or premalignancy of uterus/cervix
- •Prior myomectomy for FIGO 3-6 fibroids
- •Patients with coagulation disorders under current anticoagulation medication
- •Prior history of diagnosed intraabdominal adhesions (surgery)
- •Prior diagnosis of pelvic congestion syndrome
- •Psychiatric disease precluding a reliable estimation of pain
- •Prior surgery or treatment for deep infiltrating endometriosis
- •Acute other symptoms:
- •Urinary symptoms (dysuria, urgency, grade III stress incontinence)
- •Acute of chronic pelvic infection (cervicitis, endometritis, salpingitis, frozen pelvis)
- •Ovarian lesions
- •Sonographic signs of deep infiltrating endometriosis (DIE)
- •Intracavitary pathology (Fibroid 0-2, polyp, adhesions)
- •Retained products of conception
- •>3 small fibroids below 2 cm in largest diameter FIGO 3-8 (i.e. the presence of three fibroids below 2cm is NOT considered an exclusion criterion)
- •Presence of any fibroid >2cm.
研究组 & 干预措施
Women with a uterus
Pre - and perimenopausal women with a uterus that are scheduled for a gynaecologic ultrasound exam.
结局指标
主要结局
Association between MUSA defined ultrasound features of adenomyosis and the severity of clinical symptoms.
时间窗: At baseline (single assessment at the time of the routine ultrasound examination)
The correlation between the total number of MUSA defined ultrasound features (presence/absence; feature count) and clinical symptom severity will be assessed using the Numeric Rating Scale (NRS 0-10) for pain and the Pictorial Blood Assessment Chart (PBAC) score for abnormal bleeding. The primary outcome will be expressed as a correlation coefficient (unitless).
次要结局
- Association of individual ultrasound features with symptom severity(At baseline (single assessment at the time of the routine ultrasound examination))
- Prevalence of individual MUSA defined features(At baseline (single assessment at the time of the routine ultrasound examination.)
- Prevalence of Ultrasound Features in Symptomatic vs. Asymptomatic Participants(At baseline (single assessment at the time of the routine ultrasound examination)