fibroid myoma
Conditions
Interventions
None listed
Sponsors
Gynaecologie
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - = 1 fibroid is accessible for transvaginal ultrasound) - Maximal diameter >=1.5 cm and
Exclusion criteria
Exclusion criteria: - Any fibroid treatment in the last 3 months in case of (3) SPRM e.g. Esmya or GnRH-analogues (except for exogenous hormone exposure) or (1) no treatment - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume reduction per study group after: 1. Natural behaviour - 1 year 2. Long-term exogenous hormonal exposure - 1 year 3. SPRMs e.g. Esmya or GnRH-analogues - 3 months 4. Initiation of exogenous hormonal exposure - 1 year 5. Embolization - 6 months 6. Ablation therapy - 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All study groups: 1. UFS-Qol 2. EQ-5D score 3. PBAC-score 4. Haemoglobin level 5. Treatment failure rate 6. (Re)intervention rate | — |
Countries
Netherlands
Outcome results
None listed