Uterine Fibroid
Conditions
Brief summary
This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. We will include 200 women.
Interventions
None listed
Sponsors
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* premenopausal * no future child wish * acceptable risks for general anestesia or sedation * willing to comply with protocol
Exclusion criteria
* current or future child wish * bleeding disorder with increased risk of bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity of uterine fibroids | 6 months post treatment | Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire. minumum 0, maximum 100 where higher scores indicate higher symptom severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acceptability | 2 hours post treatment and 6 months post treatment (+/- 2 weeks) | Answer to question: if you were to recommend the treatment to a friend on a scale from 1-7 where 7 is the highest rating- what would you say. |
| Quality of Life score | 6 months post treatment | Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire.minumum 0, maximum 100 where higher scores indicate higher quality of life |
| menstrual bleeding | 6 months post treatment | Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding. |
Countries
Sweden
Outcome results
None listed