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.
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.
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
Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent.
Cohort
Cross-sectional
Not listed
Association between MUSA defined ultrasound features of adenomyosis and the severity of clinical symptoms.
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).
Association of individual ultrasound features with symptom severity
Each individual MUSA defined ultrasound feature (binary: yes/no) will be evaluated for its association with pain severity (NRS 0-10) and bleeding severity (PBAC score). Results will be reported as an effect size or correlation coefficient (unitless).
Prevalence of individual MUSA defined features
The proportion of participants who exhibit each individual MUSA defined ultrasound feature will be reported.
Prevalence of Ultrasound Features in Symptomatic vs. Asymptomatic Participants
The percentages of symptomatic participants (pain and/or abnormal bleeding) and asymptomatic participants exhibiting each MUSA defined ultrasound feature will be compared.
Exploratory Development of an Ultrasound Based Severity Grading System
An exploratory grading system integrating MUSA defined ultrasound findings with clinical symptom scores (NRS and PBAC) will be developed to propose a categorical severity classification for adenomyosis.
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Swiss GO Trial Group
Lead sponsor
University Hospital, Basel, Switzerland
Collaborator
