Adenomyosis Clinical Trial
— ADENOMICOfficial title:
Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization (UAE) Versus Ultrasound Guided Percutaneous/Transvaginal Microwave Ablation, Evaluated by Validated Questionnaires
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).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 31, 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 55 Years |
Eligibility | Inclusion Criteria: - Healthy women aged 30-55 with symptomatic adenomyosis - Premenopausal - Adenomyosis diagnosted by TVUS and MRI - Willing to comply with protocol Exclusion Criteria: - Current or future childwish - Body Mass Index >35 - Treatment with anticoagulant/bleeding disorder - Visible myomas >3cm or visible endometriosis on UL/MRI - Contraindication for UAE or general anesthesia |
Country | Name | City | State |
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Sweden | Danderyd Hospital | Stockholm |
Lead Sponsor | Collaborator |
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Karolinska Institutet |
Sweden,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Hospitalization | How long time (in days) the patient needed postoperative care in the ward, identified by the patients Medical chart | Up to 8 weeks post treatment | |
Secondary | Sick leave | How many Days until the patient resumed normal working hours | Up to 8 weeks post treatment | |
Secondary | Pain medication | How much and what type of pain medication the patient needed post operatively | Up to 8 weeks post treatment | |
Secondary | Acceptability | Patients description wether they would recommend the treatment to a friend, measured by a 7-point Likert scale (1-7, where higher number represents a greater acceptability) | 2 months and 6 months post treatment | |
Secondary | Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by PBAC (pictorial blood loss assessment chart) | Symptom improvement in regard to menstrual blood loss, PBAC ranges from 0->4000 and cut-off for the diagnose of Heavy Menstrual Bleeding is normally PBAC>100 | 6 months | |
Secondary | Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by | Symptom improvement in regard to menstrual pain, evaluated by VNRS (0-10, recorded each day of the menstrual period, where 0 is no pain and 10 worst possible pain) | 6 months | |
Secondary | 1. Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by UFS-QOL - The Health related quality of life score | 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) | 6 months |
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