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Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding

ConditionAbnormal Uterine Bleeding Due to Adenomyosis (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-50
SponsorUniversity Hospital, Bordeaux

About this trial

The present study aims to compare the efficacy (menstrual blood loss, pain, quality of life) and the safety (complications, recovery) of each conservative intervention (RFA, UAE) versus hysterectomy for the treatment of adenomyosis-related abnormal uterine bleeding, up to 2 years

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Premenopausal women aged 30 to 50 years

Women who had at least 3 prior months failed medical therapy, or a contraindication to medical therapy, or refused medical therapy for adenomyosis-related AUB

Symptomatic pure internal adenomyosis or dominant adenomyosis (with less than 5 concurrent uterine fibroids type 3-7 < 5 cm) confirmed by MRI (< 6 months) according to ESHRE criteria

AUB defined as a PBAC score >100 at baseline

Disqualifiers

Uterine cavity abnormality or obstruction confirmed via imaging modalities or hysteroscopy

Deep infiltrating posterior subperitoneal endometriosis involving contiguous digestive tract structures

Uterine malignancy within the last five years

Secreting ovarian tumor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency endometrial ablation

    Procedure/Surgery

    Radiofrequency endometrial ablation

  • Uterine artery embolization

    Procedure/Surgery

    Uterine artery embolization

  • Hysterectomy

    Procedure/Surgery

    Hysterectomy

Treatment groups

230 Participants
are divided into 3 treatment groups
Group A: Radiofrequency endometrial ablationExperimental treatment 1 intervention
Group B: Uterine artery embolizationExperimental treatment 1 intervention
Group C: HysterectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

proportion of 2-year clinical success of the intervention

proportion of 2-year clinical success of the intervention, defined as a significant reduction in menstrual blood loss (Pictorial Blood Assessment Chart-PBAC, score \<100). Women undergoing RFA or UAE and requiring subsequent hysterectomy for persistent AUB before 2 years will be considered as clinical failure.

Time frame
Year 2

Secondary outcomes

1

Proportion clinical success of the intervention

Proportion clinical success of the intervention, defined as a significant reduction in menstrual blood loss (PBAC score \<100)

Time frame
Month 1, Month 5, Year 1
2

Proportion in self-reported amenorrhea

Proportion in self-reported amenorrhea (PBAC score = 0),

Time frame
Month 1, Month 5, Year 1, Year 2
3

Mean changes in severity of dysmenorrhea between UAE and RFA

Mean changes in severity of dysmenorrhea between Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA) (visual analogue scale rating from 0 to 10),

Time frame
Year 2
4

Mean changes in pelvic pain

Mean changes in pelvic pain (visual analogue scale rating from 0-no pain to 10-extreme pain);

Time frame
Year 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

French Ministry of Social Affairs and Health

Collaborator

Source ClinicalTrials.gov
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