NAPPED I: Norwegian Adenomyosis Study I

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02201719

Collaborator

Helse Sor-Ost (Other)

100

Enrollment

Location

30.1

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.

Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.

Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.

Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.

The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.

NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis

Condition or Disease	Intervention/Treatment	Phase
Adenomyosis

Detailed Description

Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.

We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Hysterectomy Adenomyosis Adenomyosis present
Hysterectomy no adenomyosis Adenomyosis not present

Outcome Measures

Primary Outcome Measures

Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%) [within 4 weeks after 3D TVU]
Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.

Secondary Outcome Measures

Positive and negative predictive value of 3D TVU in percent (%) [within 17 weeks after 3D TVU]
Positive and negative predictive value of 3D TVU in diagnosis of adenomyosis. The histological examination is the end-point because it is still regarded to be the gold-standard in diagnosis of adenomyosis.
Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%) [within 17 weeks after 3D TVU]
The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure).
Difference in max. thickness of junction zone, in millimeters (mm) [post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU]
Compares measurements of junction zone made by 3D TVU and MRI.
Prevalence of sub- and infertility, percent (%) [at time of enrollment]
Questionnaire-based investigation. Prevalence of sub- and infertility in their medical history of the study population.
Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%) [within 17 weeks after 3D TVU]
The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure) and histopathology, which is still the gold standard.
Prevalence of miscarriages, in percent (%) [at time of enrollment]
Questionnaire-based investigation. Prevalence of miscarriages in the medical history of the study population.
Prevalence of previous gynecological surgeries, in percent (%) [at time of enrollment]
Questionnaire-based investigation. Prevalence of previous gynecological surgical interventions in the medical history of the study population.
Prevalence of previous obstetrical complications, in percent (%) [menarche to time of enrollment]
Questionnaire-based investigation. Prevalence of previous obstetrical complications in the medical history of the study population.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Premenopausal women aged 30 - 50 years old
scheduled for vaginal, abdominal or laparoscopic total hysterectomy
one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia
junction zone definable

Exclusion Criteria:

postmenopausal women,
pregnancy
gynecological cancer
GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy
junctional zone not identifiable