Uterine fibroids, myomas, uterus myomatosus
Conditions
Interventions
The intervention group will receive Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU)
The control group can choose between standard care treatment, including: hysterectomy,
Sponsors
Isala Hospital Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: • Symptomatic fibroids warranting (minimally) invasive treatment i.e. either hysterectomy, myomectomy or UAE; • Conservative treatment failed or is undesired; • Premenopausal; • =18 years of age; • Eligible for MR-HIFU treatment.
Exclusion criteria
Exclusion criteria: • Asymptomatic fibroids; • Post-menopausal; • BMI of =35kg/m2 and/or abdominal subcutis =4cm; • >5 uterine fibroids unless 1 or 2 fibroids causing the symptoms can be clearly identified; • MRI-contraindications or contrast allergy; • Current pregnancy; • Active child wish defined as desire for a pregnancy within one year after inclusion. These women will be excluded, because there is not yet consensus about the standard of care for these women. Women without active child wish but for whom a pregnancy in the future is not ruled out, can be included in the study; • Suspicion of malignancy; • Dominant adenomyosis, defined as more volume of adenomyosis rather than fibroids; • Not willing to undergo pre-treatment with Leuproreline (Lucrin) before MR-HIFU in case of a uterine fibroid with a diameter >10cm or classified as Funaki 3; • Not willing to remove an interfering intra-uterine contraception device (Mirena) prior to MR-HIFU; • Not willing or able to give informed consent; • Not eligible for MR-HIFU as determined by the multidisciplinary MR-HIFU team in Isala based on a screening MRI: - Uterine fibroid(s) classified with FIGO classification 0-1 or 8 or with a diameter 12cm even after use of manipulation techniques; - Calcified uterine fibroids or fibroids without contrast enhancement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Quality of life (QoL) at the follow-up time point of 24 months after treatment; 2.Costs consisting of: direct health care costs, costs due to loss of productivity and patient costs. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Adverse events/complications; -Length hospital stay; -Peri/post procedural pain; -Patient treatment preference and satisfaction; -(Co)-medication; -Re-interventions; -Onset menopause; -Reproductive outcomes; -Non perfused volume, fibroid shrinkage. | — |
Contacts
Public ContactMartijn Boomsma
Isala Hospital
Outcome results
None listed