Validation of the Adenomyosis Calculator

Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.

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.

Study Overview

• Status: Completed
• Conditions: Adenomyosis; Pelvic Pain Syndrome

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

• Study Contact: Name: Tina Tellum, MD; Phone Number: +4797793704; Email: tina.tellum@gmail.com

Study Locations

• Finland
  • Turku, Finland, 20521
    • Turku University Hospital
• Norway
  • Oslo, Norway, 0382
    • Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital
  • Akershus
    • Lørenskog, Akershus, Norway, 1478
      • Akershus University Hospital, Dept. of gynecology
  • Trøndelag
    • Trondheim, Trøndelag, Norway, NO-7006
      • St. Olavs Hospital, Dept. of Gynecology
  • Vestfold
    • Tønsberg, Vestfold, Norway, 3103
      • Sykehuset i Vestfold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 52 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Premenopausal (defined by having had menstruation the last six month)
• If amenorrhea with levonorgestrel intrauterine device, the woman should be < 45 years old
• Hysterectomy planned due to a benign condition
• Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3 pieces, given that the orientation of the specimen is still possible for the pathologist)
• Written consent is given
• Can communicate in Norwegian or English at the Norwegian study sites, and Finnish, Swedish or English at the Finnish study site.

Exclusion Criteria:

• Gynecological cancer present at the time of inclusion
• Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months prior to the ultrasound evaluation
• Prior endometrial ablation or resection
• Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea with levonorgestrel-intrauterine device and age >45 years.
• Need for morcellation of the uterus

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Turku University Hospital; St. Olavs Hospital; The Hospital of Vestfold; University Hospital, Akershus
• Investigators: Principal Investigator: Marit Lieng, Phd, Oslo University Hospital, Oslo, Norway

Publications and helpful links

General Publications

• Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 19, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Adenomyosis; Pelvic Pain
• Other Study ID Numbers: OUS P360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the values of all evaluated predictors in the model so that they can be used for re-calculation.
• IPD Sharing Time Frame: The data is planned to be made available within a year after the publication of all results.
• IPD Sharing Access Criteria: Access will be granted upon request and evaluation of the intended use of the data. The intended use should primarily gain improved patient care and research into adenomyosis and a detailed protocol has to be submitted.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No