Actively Recruiting

Phase Not Applicable
Age: 30Years - 55Years
FEMALE
ID04209127

Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization Versus Ultrasound Guided Microwave Ablation for Adenomyosis

Led by Karolinska Institutet · Updated on 2024-11-20

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating symptom improvement in women with adenomyosis by comparing two minimally invasive treatments: uterine artery embolization (UAE) and ultrasound-guided percutaneous or transvaginal microwave ablation. Adenomyosis is a benign condition causing pain and bleeding that can significantly affect women's lives. Traditional treatment often involved hysterectomy, but this study explores less invasive options to preserve the uterus and reduce complications. The study randomly assigns women to either microwave ablation, performed with a needle antenna guided by ultrasound or CT imaging, or uterine artery embolization, where a catheter delivers particles to block blood flow to adenomyotic tissue. Microwave ablation is done under anesthesia with a small incision or vaginally, while embolization is performed with pain management and catheterization of the femoral artery. Both treatments aim to reduce symptoms, and participants are followed up at 2 and 6 months post-treatment, with an extended follow-up for symptom recurrence. Participants will complete validated questionnaires assessing symptom severity and quality of life before and after treatment. Pain levels, menstrual blood loss, medication use, hospitalization time, and acceptability of treatment are monitored. Blood tests and MRI scans assess physical changes and ovarian function. The study lasts beyond 6 months, with long-term yearly follow-up to evaluate ongoing effects and symptom recurrence. This comprehensive monitoring ensures detailed assessment of both treatment approaches.

CONDITIONS

Brief Title

Comparing Efficacy of Microwave Vs Embolization Treatment for Adenomyosis

Who Can Participate

Age: 30Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy women aged 30 to 55 with symptomatic adenomyosis
  • Premenopausal status
  • Adenomyosis diagnosis confirmed by transvaginal ultrasound (TVUS)
  • Willingness to comply with study protocol
Not Eligible

You will not qualify if you...

  • Body Mass Index greater than 35
  • Current treatment with anticoagulants or presence of bleeding disorders
  • Contraindications for uterine artery embolization or general anesthesia

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for MRI and eligibility assessment

Treatment

Duration - Single day procedure with up to 8 weeks of recovery

Participants receive either microwave ablation treatment or uterine artery embolization to treat adenomyosis.

1 treatment visit (in-person) plus daily pain assessment for 7 days post treatment

Follow-up

Duration - 6 months post treatment

Participants have follow-up visits to evaluate symptom improvement, acceptability, and biological markers up to 6 months after treatment.

2 follow-up visits at approximately 2 months and 6 months post treatment (in-person)

Long-term Monitoring

Duration - More than 12 months

Participants may join a long-term follow-up for more than 12 months to monitor recurrence of symptoms and quality of life.

Annual clinical exams and questionnaires until study withdrawal

Trial Site Locations

Total: 1 location

1

Danderyd Hospital

Stockholm, Sweden, 182 88

Actively Recruiting

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Research Team

K

Klara Hasselrot, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Transvaginal sonographic features of diffuse adenomyosis in 18-30-year-old nulligravid women without endometriosis: association with symptoms.

S Pinzauti, L Lazzeri, C Tosti...

https://pubmed.ncbi.nlm.nih.gov/25728241

The LNG-IUS study on adenomyosis: a 3-year follow-up study on the efficacy and side effects of the use of levonorgestrel intrauterine system for the treatment of dysmenorrhea associated with adenomyosis.

Jie Sheng, Wei Yuan Zhang, Jian Ping Zhang...

https://pubmed.ncbi.nlm.nih.gov/19185671

Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial.

Annefleur Machteld de Bruijn, Paul Nm Lohle, Judith Af Huirne...

https://pubmed.ncbi.nlm.nih.gov/29496654