Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
NCT ID: NCT07195305
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
230 participants
INTERVENTIONAL
2026-01-31
2029-05-31
Brief Summary
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Detailed Description
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Radiofrequency ablation (RFA) is intended to ablate the endometrial lining of the uterus on pre-menopausal women with AUB due to benign causes for whom childbearing is complete. This outpatient procedure is well tolerated, with 10% of post-operative adverse events within one year, mainly not serious like pelvic pain/cramping and vaginal discharge/infection.
Uterine artery embolization (UAE) is as a minimally invasive treatment for symptomatic uterine fibroids since 1995. This procedure is also well tolerated, with efficacy and satisfaction rates of 85% at 2 years, performed usually as a day case or with a short hospital stay of 12-24h to manage immediate post-operative pain.
Therefore the extension of the indications of both techniques in AUB associated with adenomyosis should be questioned.
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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency endometrial ablation
Radiofrequency endometrial ablation performed using NovaSure®
Radiofrequency endometrial ablation
Radiofrequency endometrial ablation
Uterine artery embolization
Uterine artery embolization carried out under the guidance of digital subtraction angiography
Uterine artery embolization
Uterine artery embolization
Hysterectomy
Hysterectomy
Hysterectomy
Hysterectomy
Interventions
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Radiofrequency endometrial ablation
Radiofrequency endometrial ablation
Uterine artery embolization
Uterine artery embolization
Hysterectomy
Hysterectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* Uterine ultrasound measurement of 6.0-12.0 cm (external os to internal fundus)
* Women with an indication for hysterectomy for adenomyosis-related AUB and accepting hysterectomy
* Highly effective contraception for women of childbearing potential, maintained until the onset of menopause
* Affiliated or beneficiary of health insurance
* Signed informed consent
Exclusion Criteria
* Deep infiltrating posterior subperitoneal endometriosis involving contiguous digestive tract structures
* Uterine malignancy within the last five years
* Secreting ovarian tumor
* Atypical endometrial hyperplasia
* Unaddressed high grade cervical intra-epithelial lesions
* Active sexually transmitted disease or pelvic inflammatory disease
* Documented or suspected coagulopathies or long-term blood-thinner medications
* Prior transmural myomectomy or prior endometrial ablation
* Plasma FSH level \> 40 IU/mL
* Any contraindication to angiography (including iodine allergy and creatinine clearance \< 60mL/min)
* Any contraindication to MRI (claustrophobia, pace maker, etc.)
* Any contraindication to the use of Embosphere®, Embozene® or NovaSure® according to the instruction for use
* Women who are pregnant, breastfeeding, or who are planning to become pregnant
* Any condition or any situation that would prohibit women from coming to the investigational center for the 6 months follow-up
* Women unable to understand the nature, risks, significance and implications of the clinical investigation
* Women under legal protection
30 Years
50 Years
FEMALE
No
Sponsors
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French Ministry of Social Affairs and Health
UNKNOWN
University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU Bordeaux
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2024/47
Identifier Type: -
Identifier Source: org_study_id
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