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

N/ANot Yet RecruitingNCT07195305

University Hospital, Bordeaux230 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)

Interventions

Radiofrequency endometrial ablationPROCEDURE

Radiofrequency endometrial ablation

Uterine artery embolizationPROCEDURE

Uterine artery embolization

HysterectomyPROCEDURE

Hysterectomy

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Bordeaux

Bordeaux, France

Outcomes

Primary Outcomes

proportion of 2-year clinical success of the intervention

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.

Time frame: Year 2

Secondary Outcomes

Proportion clinical success of the intervention

Proportion clinical success of the intervention, defined as a significant reduction in menstrual blood loss (PBAC score \<100)

Time frame: Month 1, Month 5, Year 1

Proportion in self-reported amenorrhea

Proportion in self-reported amenorrhea (PBAC score = 0),

Time frame: Month 1, Month 5, Year 1, Year 2

Mean changes in severity of dysmenorrhea between UAE and RFA

Mean changes in severity of dysmenorrhea between Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA) (visual analogue scale rating from 0 to 10),

Time frame: Year 2

Mean changes in pelvic pain

Mean changes in pelvic pain (visual analogue scale rating from 0-no pain to 10-extreme pain);

Time frame: Year 2

Mean changes in deep dyspareunia

Mean changes in deep dyspareunia (visual analogue scale rating from 0-no pain to 10-extreme pain);

Time frame: Year 2

Mean changes in pelvic distension

Mean changes in pelvic distension (visual analogue scale rating from 0-no pain to 10-extreme pain);

Central Contacts

Jean-Luc Brun, MD, PhD

CONTACT

+33 5 56 79 59 85 jean-luc.brun@chu-bordeaux.fr

Marc Sapoval, MD, PhD

CONTACT

+33 1 56 09 37 41 marc.sapoval2@aphp.fr

Data from ClinicalTrials.gov

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