Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization (UAE) Versus Ultrasound Guided Percutaneous/transvaginal Microwave Ablation, Evaluated by Validated Questionnaires
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by UFS-QOL - The score on Symptom Severity Scale
研究概览
简要总结
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).
详细描述
Single blinded randomized controlled study of symptom improvement after uterine artery embolization (UAE) versus ultrasound guided percutaneous/transvaginal microwave ablation, evaluated by validated questionnaires.
Background
Adenomyosis is a benign gynecological condition, where endometrial glands and stroma invades the myometrial walls of the uterus. The disease is thought to be estrogen-dependent, but the etiology, as well as the prevalence, is currently unknown. Known risk-factors are previous uterine surgery and parity, although the disease has been found also in nulligravida with no previous uterine trauma. Adenomyosis can cause severe dysmenorrhea, menorrhagia, chronic pelvic pain and infertility. Historically diagnosis has been made post hysterectomy by pathologists, however with transvaginal ultrasound (TVUS) as well as MRI the condition is now possible to identify with non-invasive methods.
Hysterectomy has previously been seen as the golden standard treatment for adenomyosis, but may cause long-term side effects such as genitovaginal prolapse. It also carries a substantial risk of short term complications such as infections and organ damage.
Symptomatic treatment such as the levonogestrel intrauterine system (LNG-IUS) can be effective, however there is a risk of expulsion and irregular bleedings.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women aged 30-55 with symptomatic adenomyosis
- •Premenopausal
- •Adenomyosis diagnosted by TVUS
- •Willing to comply with protocol
排除标准
- •Body Mass Index >35
- •Treatment with anticoagulant/bleeding disorder
- •Contraindication for UAE or general anesthesia
研究组 & 干预措施
Microwave treatment
Percutaneous or vaginal application of microwave antenna with microwave treatment for adenomyosis
干预措施: Microwave treatment via needle antenna (Procedure)
Control
Uterine artery embolization; percutaneous application of a catheter into the femoral artery or branches thereof
干预措施: Embolization of uterine artery or branches thereof (routine treatment where polyvinyl alcohol particles are released into the predefined bloodstream) (Procedure)
结局指标
主要结局
1. Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by UFS-QOL - The score on Symptom Severity Scale
时间窗: 6 months
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)
次要结局
- Pain medication(Up to 8 weeks post treatment)
- Acceptability(2 months and 6 months post treatment)
- Reduction of adenomyosis by imaging(6 months)
- Hospitalization(Up to 8 weeks post treatment)
- Sick leave(Up to 8 weeks post treatment)
- Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by PBAC (pictorial blood loss assessment chart)(6 months)
- Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by(6 months)
- 1. Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by UFS-QOL - The Health related quality of life score(6 months)
研究者
Helena Kopp Kallner
Senior Consultant, PhD
Karolinska Institutet