Prospective Observational Study of Microwave Ablation of Uterine Fibroids (MyoMwa)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Turku University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Symptom severity of uterine fibroids and quality of life
Study Overview
Brief Summary
This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment or symptomatic uterine fibroids. We will include 100 women.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 56 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •symptomatic fibroids
- •premenopausal status
- •acceptable risks for general anestesia or sedation
- •willing to undergo mwa treatment and participate in the study
Exclusion Criteria
- •postmenopausal status
- •bleeding disorder with increased risk of bleeding
Arms & Interventions
patients with symptomatic uterine fibroids
Patients with symptomatic uterine fibroids, who will undergo microwave ablation of fibroids as a clinical treatment are recruited in this study.
Intervention: microwave ablation (Procedure)
Outcomes
Primary Outcomes
Symptom severity of uterine fibroids and quality of life
Time Frame: 12 months
Score of validated form Uterine Fibroid symptom - Quality of life questinnaire. minimum 0, maximum 100 where higher scores indicate higher symptom severity
suitability of mwa for general fibroid population
Time Frame: 12 months
objective and subjective outcome of mwa in different fibroid types, sizes and locations
Secondary Outcomes
No secondary outcomes reported
Investigators
Kirsi Joronen
Principal Investigator
Turku University Hospital