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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Процедура Radiofrequency endometrial ablation
  Radiofrequency endometrial ablation
• Процедура Uterine artery embolization
  Uterine artery embolization
• Процедура Hysterectomy
  Hysterectomy

Первичные конечные точки

• proportion of 2-year clinical success of the intervention [Срок оценки: Year 2]

Вторичные конечные точки (12)

• Proportion clinical success of the intervention [Срок оценки: Month 1, Month 5, Year 1]
• Proportion in self-reported amenorrhea [Срок оценки: Month 1, Month 5, Year 1, Year 2]
• Mean changes in severity of dysmenorrhea between UAE and RFA [Срок оценки: Year 2]
• Mean changes in pelvic pain [Срок оценки: Year 2]
• Mean changes in deep dyspareunia [Срок оценки: Year 2]
• Mean changes in pelvic distension [Срок оценки: Year 2]
• Mean duration of hospital stay [Срок оценки: Hospital discharge]
• Mean time to return to normal life [Срок оценки: Month 1]
• Mean change in quality of life [Срок оценки: Year 2]
• Mean change in endometriosis quality of life [Срок оценки: Year 2]
• Mean change in sexual life quality [Срок оценки: Year 2]
• Mean satisfaction with the intervention [Срок оценки: Year 2]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• CHU Bordeaux — Bordeaux
• APHP - Hôpital Antoine Béclère — Clamart
• CHU Limoges — Limoges
• CHU Montpellier — Montpellier

Идентификаторы

NCT: NCT07195305 · CHUBX 2024/47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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