Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency endometrial ablation, Uterine artery embolization, Hysterectomy.
- Who it may be relevant to
- Registry conditions: Abnormal Uterine Bleeding Due to Adenomyosis (Disorder). Basic parameters: 30 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Women With Adenomyosis-related Abnormal Uterine Bleeding Eligible for Hysterectomy: a Non-inferiority Randomized Clinical Trial Comparing Each Intervention to Hysterectomy
Overview
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
Detailed description
Adenomyosis is defined by the presence of ectopic non-atypical endometrial glands and stroma within the smooth muscle fibers of the myometrium causing reactive hypertrophy of the uterus. The prevalence of adenomyosis is approximately 20% before 40 years, and probably higher in the following decade. One-third of women with adenomyosis are symptomatic. Symptoms include abnormal uterine bleeding (AUB) (40-50%), pelvic pain (dysmenorrhea 15-30%, dyspareunia) and are related to the uniformly enlarged and globular uterus (distension, swelling). Adenomyosis can be diagnosed by transvaginal ultrasonography and/or magnetic resonance imaging (MRI). Symptoms associated with adenomyosis can be treated by hormonal or non-hormonal medications. When medical treatment fails, a hysterectomy is proposed to women who do not consider childbearing. For women who wish to preserve their uterus, two alternatives are possible.
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
Interventions
- Procedure Radiofrequency endometrial ablation
Radiofrequency endometrial ablation - Procedure Uterine artery embolization
Uterine artery embolization - Procedure Hysterectomy
Hysterectomy
Primary outcome measures
- proportion of 2-year clinical success of the intervention [Time frame: Year 2]
Secondary outcome measures (12)
- Proportion clinical success of the intervention [Time frame: Month 1, Month 5, Year 1]
- Proportion in self-reported amenorrhea [Time frame: Month 1, Month 5, Year 1, Year 2]
- Mean changes in severity of dysmenorrhea between UAE and RFA [Time frame: Year 2]
- Mean changes in pelvic pain [Time frame: Year 2]
- Mean changes in deep dyspareunia [Time frame: Year 2]
- Mean changes in pelvic distension [Time frame: Year 2]
- Mean duration of hospital stay [Time frame: Hospital discharge]
- Mean time to return to normal life [Time frame: Month 1]
- Mean change in quality of life [Time frame: Year 2]
- Mean change in endometriosis quality of life [Time frame: Year 2]
- Mean change in sexual life quality [Time frame: Year 2]
- Mean satisfaction with the intervention [Time frame: Year 2]
Eligibility criteria
Inclusion criteria
- 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
- 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
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 4 centers
- CHU Bordeaux — Bordeaux
- APHP - Hôpital Antoine Béclère — Clamart
- CHU Limoges — Limoges
- CHU Montpellier — Montpellier
Identifiers
NCT: NCT07195305 · CHUBX 2024/47