Norwegian Adenomyosis Study I (NAPPED I)

University of Oslo (UIO)

Status: Completed

Conditions: Adenomyosis

Study type: Observational

Funder types: Other

Identifiers

NCT02201719

2014/637a

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Hysterectomy Adenomyosis

Description:

Adenomyosis present

Hysterectomy no adenomyosis

Description:

Adenomyosis not present