Adenomyosis: A Clinical Review of a Challenging Gynecologic Condition.
Jennifer Struble, Shannon Reid, Mohamed A Bedaiwy
https://pubmed.ncbi.nlm.nih.gov/26427702Actively Recruiting
Led by Karolinska Institutet · Updated on 2024-11-20
70
Participants Needed
1
Research Sites
N/A
Total Duration
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
Comparing Efficacy of Microwave Vs Embolization Treatment for Adenomyosis
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for MRI and eligibility assessment
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
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)
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
Total: 1 location
1
Danderyd Hospital
Stockholm, Sweden, 182 88
Actively Recruiting
K
Klara Hasselrot, MD PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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