An observational study in Adenomyosis and Pelvic Pain Syndrome, sponsored by Oslo University Hospital. Completed at 5 sites in 2 countries. Open to female participants aged Up to 52 Years. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Oslo University Hospital · Observational
Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed.
In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.
135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.
This study's enrollment of 500 is above the median of 150 across 56 observational studies indexed under Adenomyosis.
Browse Adenomyosis studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A consecutive sample of women that are scheduled for a hysterectomy at one of the study sites and fulfill eligibility criteria are invited to participate.
Exclusion Criteria:
Diagnostic accuracy of the prediction model for adenomyosis
Diagnostic accuracy will be described using sensitivity (in %), specificity (in %), positive predictive value (in %), negative predictive value (in %), positive likelihood ratio (calculated by sensitivity/1-specificity), negative likelihood ratio (calculated as 1-sensitivity/specificity) and the area under the receiver-operator curve (as calculated with the (0-1) of the model.
Time frame: 1 year
Intraclass correlation coefficient (ICC) between readers
ICC values are categorized as follows: 0-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement; and 0.81-1, almost perfect agreement
Time frame: 2 years
Plan to share: Yes — We will share the values of all evaluated predictors in the model so that they can be used for re-calculation.
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital