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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 5
- 主要终点
- proportion of 2-year clinical success of the intervention
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Radiofrequency endometrial ablation
Radiofrequency endometrial ablation performed using NovaSure®
干预措施: Radiofrequency endometrial ablation (Procedure)
Uterine artery embolization
Uterine artery embolization carried out under the guidance of digital subtraction angiography
干预措施: Uterine artery embolization (Procedure)
Hysterectomy
Hysterectomy
干预措施: Hysterectomy (Procedure)
结局指标
主要结局
proportion of 2-year clinical success of the intervention
时间窗: Year 2
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.
次要结局
- Proportion clinical success of the intervention(Month 1, Month 5, Year 1)
- Proportion in self-reported amenorrhea(Month 1, Month 5, Year 1, Year 2)
- Mean changes in severity of dysmenorrhea between UAE and RFA(Year 2)
- Mean changes in pelvic pain(Year 2)
- Mean change in sexual life quality(Year 2)
- Mean satisfaction with the intervention(Year 2)
- Rate and severity of intra-operative complications(Hospital discharge)
- Analgesic and/or non-steroidal anti-inflammatory drug intake(Week 1)
- Mean changes in deep dyspareunia(Year 2)
- Mean change in endometriosis quality of life(Year 2)
- Mean changes in pelvic distension(Year 2)
- Mean duration of hospital stay(Hospital discharge)
- Mean time to return to normal life(Month 1)
- Mean change in quality of life(Year 2)
- Proportion of women with correction of iron-deficiency anemia(Year 2)
- Severity of intra-operative complications(Hospital discharge)
- Severity of post-operative adverse events(Year 2)
- Mean change in junctional zone thickness(Month 6)
- Rate of post-operative adverse events(Year 2)
- Mean change in percentage of necrosis(Month 6)
- Mean change in uterine vascularization(Month 6)
- Mean change of hormonal parameters(Year 2)