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

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

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

Treatments tested in this trial

  • Radiofrequency endometrial ablation
  • Uterine artery embolization
  • Hysterectomy

Treatment groups

230 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University Hospital, Bordeaux

Lead sponsor

French Ministry of Social Affairs and Health

Collaborator