Linking uterine ultrasound features to adenomyosis symptoms
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms (MUSA 3)
This project will see if specific ultrasound signs in the uterine muscle match the symptoms reported by pre- and perimenopausal women who come for a gynecologic ultrasound.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Swiss GO Trial Group Research network |
| Locations | 3 sites (Sosnowiec and 2 other locations) |
| Trial ID | NCT07397715 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, cross-sectional observational study that enrolls consecutive pre- and perimenopausal women presenting for gynecologic ultrasound, both with and without symptoms. Participants have one visit during which a standardized transvaginal ultrasound using MUSA-defined features is performed and they complete questionnaires on bleeding and pain. Investigators will compare ultrasound features (direct and indirect signs of adenomyosis) with reported symptoms and aim to develop a standardized reporting system to grade disease severity. There are no interventions and data are collected only at the single visit.
Who should consider this trial
Good fit: Ideal candidates are consenting pre- and perimenopausal women presenting for a gynecologic ultrasound, whether they have symptoms or not, who are not pregnant and agree to fill out symptom and bleeding questionnaires.
Not a fit: Women who are postmenopausal, currently pregnant, have recent relevant pelvic surgery, known uterine/cervical malignancy, or other excluded comorbidities are not eligible and are unlikely to benefit from this imaging-focused project.
Why it matters
Potential benefit: If successful, the work could improve noninvasive diagnosis and create a standardized ultrasound reporting system to better match imaging findings with patient symptoms.
How similar studies have performed: Previous work and the MUSA consensus support using ultrasound features to diagnose adenomyosis, but links between those imaging signs and symptom severity and a validated severity reporting system remain incompletely established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sosnowiec and 2 other locations
- Medical University of Silesia — Sosnowiec, Poland (Recruiting)
- Hospital Universitari Dexeus — Barcelona, Spain (Recruiting)
- University Hospital Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Principal investigator: Gwendolin Manegold-Brauer, Prof. Dr. — Deputy Head Physician, Obstetrics and Prenatal Medicine
- Study coordinator: Gwendolin Manegold-Brauer, Prof. Dr.
- Email: gwendolin.manegold-brauer@usb.ch
- Phone: +41612659046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.