MYOMEX-2
Recruiting
- Conditions
- symptomatic uterine fibroidsSymptomatische uterine myomen
- Registration Number
- NL-OMON25181
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 179
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
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Asymptomatic fibroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes with regard to patient:<br /><br>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. <br /><br /><br><br>Primary outcomes with regard to costs (using internet medical consumption questionnaires; iMCQ):<br /><br>1)Direct healthcare costs<br /><br>2)Costs due to loss of productivity (absenteeism from work)<br /><br>3)Patient costs (informal care, other care services paid for by patients themselves)<br>
- Secondary Outcome Measures
Name Time Method Secondary outcomes with regard to patient:<br /><br>1)What is the effect of the intervention on Quality-of-Life (parameters), pain, societal participation and sexual functioning?<br /><br>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. <br /><br>3)What is the re-intervention rate in both treatment groups and how many patients choose for an intervention after treatment with UPA? <br /><br>4) What is the effect on patient preference and satisfaction? <br /><br>5) Which complications/side-effects occur? <br /><br>6) What is the effect of UPA-usage on the blood results, regarding liver function? <br /><br>7) Which sub-groups benefit most within the study group (subgroup-analysis)<br>