An interventional study of Radiofrequency endometrial ablation and Uterine artery embolization in Abnormal Uterine Bleeding Due to Adenomyosis (Disorder), sponsored by University Hospital, Bordeaux. Recruiting at 4 sites in France. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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
135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.
This study's planned enrollment of 230 is above the median of 100 across 73 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiofrequency endometrial ablation performed using NovaSure®
Procedure: Radiofrequency endometrial ablation
Uterine artery embolization carried out under the guidance of digital subtraction angiography
Procedure: Uterine artery embolization
Hysterectomy
Procedure: Hysterectomy
Radiofrequency endometrial ablation
Uterine artery embolization
Hysterectomy
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
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);
Time frame: Year 2
Mean duration of hospital stay
Mean duration of hospital stay (in days);
Time frame: Hospital discharge
Mean time to return to normal life
Mean time to return to normal life (in days);
Time frame: Month 1
Mean change in quality of life
Mean change in quality of life assessed using UFS-QoL questionnaire (Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire, from 29 poins (best health-related quality of life to 145 (worse health-related quality of life)
Time frame: Year 2
Mean change in endometriosis quality of life
Mean change in endometriosis quality of life assessed using EHP-5 questionnaire (Short form endometriosis health profile, from 0 (best possible state of health) to 100 (worst possible state of health)
Time frame: Year 2
Mean change in sexual life quality
Mean change in sexual life quality using FSFI questionnaire (Female Sexual Function Index from 2 (worse sexual life quality to 36 (best sexual life quality; 26.55 indicating the lower score reflecting the existence of sexual disorders
Time frame: Year 2
Mean satisfaction with the intervention
Mean satisfaction with the intervention (7-point Likert scale) from hospital discharge to 2 years;
Time frame: Year 2
Proportion of women with correction of iron-deficiency anemia
Proportion of women with correction of iron-deficiency anemia, if diagnosed at baseline
Time frame: Year 2
Rate and severity of intra-operative complications
Rate and severity of intra-operative complications (according to Clavien Dindo classification)
Time frame: Hospital discharge
Severity of intra-operative complications
Severity of intra-operative complications (according to Clavien Dindo classification)
Time frame: Hospital discharge
Analgesic and/or non-steroidal anti-inflammatory drug intake
Analgesic and/or non-steroidal anti-inflammatory drug intake (type, daily dose, duration)
Time frame: Week 1
Rate of post-operative adverse events
Rate of post-operative adverse events
Time frame: Year 2
Severity of post-operative adverse events
Severity of post-operative adverse events
Time frame: Year 2
Mean change in junctional zone thickness
Mean change in MRI junctional zone thickness accordingly to European Society of Human Reproduction and Embryology-ESHRE- criteria bewteen Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Time frame: Month 6
Mean change in percentage of necrosis
Mean change in MRI percentage of necrosis accordingly to European Society of Human Reproduction and Embryology-ESHRE- criteria bewteen Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Time frame: Month 6
Mean change in uterine vascularization
Mean change in MRI uterine vascularization accordingly to European Society of Human Reproduction and Embryology-ESHRE- criteria bewteen Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Time frame: Month 6
Mean change of hormonal parameters
Mean change of hormonal parameters (FH, estradiol), if post-operative amenorrhea occurred after Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Time frame: Year 2
Plan to share: No
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University Hospital, Bordeaux