Comparing Efficacy of Microwave Vs Embolization Treatment for Adenomyosis
ConditionAdenomyosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-55
SponsorKarolinska Institutet
About this trial
Single blinded randomized controlled study of symptom improvement after uterine artery embolization (UAE) versus ultrasound guided percutaneous/transvaginal microwave ablation, evaluated by validated questionnaires.
Adenomyosis is a benign condition causing pain and bleeding disorders in many women. Hysterectomy has historically been the golden standard for treatment as well as (postoperatively) diagnosis of the disease. In accordance with refined diagnostic tools such as ultrasound and/or MRI, minimally invasive treatments for adenomyosis are being explored.
We plan to compare two minimally invasive techniques: embolization of the uterine artery (a commonly used procedure) and microwave ablation of adenomyotic tissue (previously only in clinical use in China).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy women aged 30-55 with symptomatic adenomyosis
Premenopausal
Adenomyosis diagnosted by TVUS
Willing to comply with protocol
Disqualifiers
Body Mass Index >35
Treatment with anticoagulant/bleeding disorder
Contraindication for UAE or general anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Microwave treatment via needle antenna
Procedure/SurgeryMicrowave treatment via needle antenna, (Emprint Covidien microwave ablation system) either percutaneous or vaginally administrated
Embolization of uterine artery or branches thereof (routine treatment where polyvinyl alcohol particles are released into the predefined bloodstream)
Procedure/SurgeryEmbolization via percutaneous catheter
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Microwave treatmentExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
1. Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by UFS-QOL - The score on Symptom Severity Scale
Symptom improvement evaluated by the validated questionnaire UFS-QOL, which is subdivided into Symptom Severity Scale (0-100, where higher number represent worsened symptoms) and HRQL items (concern, activities, energy/mood, control, self-consciousness and sexual function, range 0-100 where higher numbers represent better Quality of Life)
Time frame
6 monthsSecondary outcomes
1
Reduction of adenomyosis by imaging
Reduction of uterus volume/adenomyosis affected areas, measured as lesional size (in mm or cm) measured by Transvaginal ultrasound and/or MRI
Time frame
6 months2
Hospitalization
How long time (in days) the patient needed postoperative care in the ward, identified by the patients Medical chart
Time frame
Up to 8 weeks post treatment3
Sick leave
How many Days until the patient resumed normal working hours
Time frame
Up to 8 weeks post treatment4
Pain medication
How much and what type of pain medication the patient needed post operatively
Time frame
Up to 8 weeks post treatmentSponsors and contacts
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Source ClinicalTrials.gov