Uterine fibroids Urological and Genital Diseases
Conditions
Interventions
Myomectomy, Surgical removal of fibroid via an excision(s)
Uterine Artery Embolisation (UAE) - introduction of an embolic agent which blocks the blood supply to the fibroid causing it
Study Entry : Single Randomisation only
Sponsors
Oxford University (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with symptomatic fibroids who do not wish to have a hysterectomy 2. Women considered suitable for either treatment (myomectomy or embolisation) and having no strong preference for a particular treatment 3. Clinical team uncertain as to which treatment is indicated 4. Written informed consent Target Gender: Female; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Recent or ongoing pelvic inflammatory disease 2. Severe radiographic contrast medium allergy 3. Significant adenomyosis, as identified by transvaginal ultrasound or magnetic resonance imaging (MRI) 4. Concurrent adenomyosis where fibroids are believed to the predominant cause of symptoms will be eligible 5. Positive pregnancy test 6. Refusal to accept hysterectomy, in the event of an intra-operative complication 7. Refusal to accept surgery or embolisation as treatment option 8. Post-menopausal, as defined as greater than one year since previous menstrual period 9. Suspected malignancy 10. Age < 18 11. Current participation in double blind, placebo controlled trials of drugs or other surgical interventions for heavy menstrual bleeding or fibroids 12. Unable to provide informed consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity (Scotland) Act 2000) 13. A non-English speaker where translation or interpretation facilities are insufficient to guarantee informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 03/05/2019: Quality of life assessed using the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) tool. The health-related quality of life (HRQoL) domain will be the primary outcome, whilst the symptom domain will be a secondary outcome. The HRQoL score at two years of follow-up will be considered the primary timepoint. Previous primary outcome measure: The change in the quality of life experienced by women after they undergo UAE or myomectomy. This will be reported after two years and four years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/05/2019: 1. Health-related quality of life assessed using the HRQoL domain from the UFS-QoL questionnaire at 6 months, 1 year and 4 years 2. Symptom severity assessed using the symptom severity domain from the UFS-QoL questionnaire at 6 months, 1, 2 and 4 years 3. EQ-5D-3L score assessed using the EuroQoL EQ-5D-3L questionnaire at 6 months, 1, 2 and 4 years 4. Health thermometer score assessed using the EuroQoL EQ-5D-3L questionnaire at 6 months, 1, 2 and 4 years 5. Menstrual blood loss – rates of amenorrhea and non-heavy bleeding assessed using the Pictorial Blood loss Assessment Chart (PBAC) at 6 months, 1, 2 and 4 years 6. Pregnancy outcomes – pregnancy (reported by the women in the first instance), live birth, miscarriage, stillbirth and termination assessed using a participant questionnaire over 2 and 4 years 7. Adverse events – all adverse outcomes considered to be related to the study protocol or intervention will be collected using clinical reports and participant questionnaire over 2 and 4 years 8. Participant responses to ‘would you have your operation again?’, assessed at 6 months, 1, 2 and 4 years 9. Participant responses to ‘would you recommend operation to a friend?’, assessed at 6 months, 1, 2 and 4 years 10. Length of hospital stay assessed using clinical reports over 2 and 4 years 11. Further treatment for incomplete removal or recurrence of symptoms, including hysterectomies, assessed using a participant questionnaire over two and four years 12. Ovarian reserve (AMH, FSH and LH levels) measured using blood samples at 6 weeks, 6 months and at 1 year Previous secondary outcome measures: 1. Changes in the level of ovarian hormones after UAE or myomectomy 2. Changes in me | — |
Countries
England, United Kingdom
Outcome results
None listed