The myoma vascularity study: Sonographic features of fibroids before and during non-surgical therapy and/or expectant management.

20-30% of women of reproductive age have leiomyomas, causing symptoms like
dysmenorrhea and pelvic pain which both effect quality of life.[1-4] The
natural behaviour of uterine fibroids is to grow between 7 to 84% in 3 to 12
months.[5-7] Non-surgical options to treat uterine fibroids are non-hormonal or
hormonal medical therapies and minimally invasive interventional radiologic
techniques. Exogenous hormone exposure including COC, POP or Mirena give in
conflicting literature minimal growth to 60% volume shrinkage. [8, 9]]
Selective progesteron receptor modulator e.g. Esmya and GnRH-analogues intent
to reduce fibroids volume after several months; GnRH-agonists provide a 31-63%
shrinkage and less frequently applied GnRH-antagonists 14.3 - 42.7%.[10-16]
Esmya gives a volume reduction varying between 10 to 48%.[17] Radiological
technique like embolization decreases dominant fibroid volume with 40-70%.[1,
18-22] UAE fails in case of devascularized or minimal vascularized
fibroids.[23] Ablation techniques show shrinkage up to a maximum of 90%
depending e.g. which treatment.[24-41] Clear prognostic models to predict the
effect on fibroid related symptoms and volume reduction are lacking. We
postulate higher vascularity to be related to 1) larger fibroid growth during
the natural course or during exogenous hormonal exposure; 2) more effective
shrinkage during progestogens, GnRH-analogues, SPRMs e.g. Esmya and UAE; but 3)
less effective after ablation therapy.

References see Attachment C1.

To study the value of sonographic features including vascularity in the
prediction of fibroids* volume change at follow-up during their (1) natural
course or (2) long-term use of exogenous hormone exposure; after initiation of
(3) SPRMs e.g. Esmya or GnRH-analogues treatment or (4) exogenous hormonal
exposure; or after (5) embolization or (6) ablation therapy.

Observational cohort study during 5 years in the outpatient clinic.

There are no risks associated with this research as the intervention concerns
questionnaires, blood tests and vaginal ultrasound. These measurements are also
applied in daily practice, the burden for the patient is time. Extra in the
contect of the study is a couple of times a questionnaires which last a maximum
of 5-15 minutes. Some of the questionnaires are standard care. The treatment
considering the fibroid(s) is independent of this research.