symptomatic uterine fibroids Symptomatische uterine myomen
Conditions
Interventions
Patients are randomly assigned in a 2:1 ratio to two groups. One group (N=60) will receive no additional medicinal treatment and will undergo standard surgical treatment (hysterectomy, myomectomy or u
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: Women visiting the gynecological outpatient clinic with symptomatic fibroids will be screened for eligibility. In order to be eligible to participate in this trial, a subject must meet all of the following criteria: - Symptomatic fibroids warranting surgical treatment, either hysterectomy, myomectomy or uterine artery embolization - Conservative treatment failed or is undesired - Pre-menopausal - >18 years of age
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Asymptomatic fibroids - Current pregnancy or unwillingness to use contraception - Suspicion of malignancy - Current use of Ulipristal - Contra-indication for the use of Ulipristal - Not willing or able to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes with regard to patient: 1)Fibroid-specific quality-of-life, measured by the Uterine Fibroid Symptom-questionnaire (UFS-QOL) symptom severity score (SSS)outcome at 24 months after randomization. Primary outcomes with regard to costs (using internet medical consumption questionnaires; iMCQ): 1)Direct healthcare costs 2)Costs due to loss of productivity (absenteeism from work) 3)Patient costs (informal care, other care services paid for by patients themselves) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes with regard to patient: 1) What is the effect of the intervention on Quality-of-Life (parameters), pain, societal participation and sexual functioning? 2) What is the effect of the intervention on fibroid specific complaints such as volume reduction (UPA group); amount of menstrual bleeding (PBAC-score) and Hemoglobin level. 3)What is the re-intervention rate in both treatment groups and how many patients choose for an intervention after treatment with UPA? 4) What is the effect on patient preference and satisfaction? 5) Which complications/side-effects occur? 6) What is the effect of UPA-usage on the blood results, regarding liver function? 7) Which sub-groups benefit most within the study group (subgroup-analysis) | — |
Contacts
Public ContactMei-An Middelkoop
Outcome results
None listed