Clinical trial · Observational
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms (MUSA 3)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyosis of Uterus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Women with a uterus
- description
- Pre - and perimenopausal women with a uterus that are scheduled for a gynaecologic ultrasound exam.
Primary outcomes (1)
- measure
- Association between MUSA defined ultrasound features of adenomyosis and the severity of clinical symptoms.
- timeFrame
- At baseline (single assessment at the time of the routine ultrasound examination)
- description
- 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).
Secondary outcomes (3)
- measure
- Association of individual ultrasound features with symptom severity
- timeFrame
- At baseline (single assessment at the time of the routine ultrasound examination)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available