Comparing Efficacy of Microwave Vs Embolization Treatment for Adenomyosis

NCT04209127 | Recruiting DMC

• 1 other identifier: ADENOMIC1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Adenomyosis

Outcome Measures

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)

  6 months

Secondary Outcomes (8)

• Reduction of adenomyosis by imaging

  6 months

• Hospitalization

  Up to 8 weeks post treatment

• Sick leave

  Up to 8 weeks post treatment

• Pain medication

  Up to 8 weeks post treatment

• Acceptability

  2 months and 6 months post treatment

Study Arms (2)

Microwave treatment

EXPERIMENTAL

Percutaneous or vaginal application of microwave antenna with microwave treatment for adenomyosis

Procedure: Microwave treatment via needle antenna

Control

ACTIVE COMPARATOR

Uterine artery embolization; percutaneous application of a catheter into the femoral artery or branches thereof

Procedure: Embolization of uterine artery or branches thereof (routine treatment where polyvinyl alcohol particles are released into the predefined bloodstream)

Interventions

Microwave treatment via needle antenna PROCEDURE

Microwave treatment via needle antenna, (Emprint Covidien microwave ablation system) either percutaneous or vaginally administrated

Microwave treatment

Embolization of uterine artery or branches thereof (routine treatment where polyvinyl alcohol particles are released into the predefined bloodstream) PROCEDURE

Embolization via percutaneous catheter

Control

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 30-55 with symptomatic adenomyosis
• Premenopausal
• Adenomyosis diagnosted by TVUS
• Willing to comply with protocol

You may not qualify if:

• Body Mass Index \>35
• Treatment with anticoagulant/bleeding disorder
• Contraindication for UAE or general anesthesia

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Danderyd Hospital

Stockholm, 182 88, Sweden

RECRUITING

Related Publications (18)

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  PMID: 30306813 BACKGROUND

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  PMID: 28118773 BACKGROUND

• Xu RF, Zhang J, Han ZY, Zhang BS, Liu H, Li XM, Ge HL, Dong XJ. Variables associated with vaginal discharge after ultrasound-guided percutaneous microwave ablation for adenomyosis. Int J Hyperthermia. 2016 Aug;32(5):504-10. doi: 10.3109/02656736.2016.1150523. Epub 2016 Apr 18.

  PMID: 27087631 BACKGROUND

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• Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

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  PMID: 22867776 BACKGROUND

MeSH Terms

Conditions

Adenomyosis

Interventions

Uterine Artery Embolization; Ethanol

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Alcohols; Organic Chemicals

Study Officials

• Helena Kopp Kallner, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klara Hasselrot, MD PhD

CONTACT

+46812358927; klara.hasselrot@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, PhD

Model Details: RCT with inteventional cohort continuation

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 23, 2019
• Study Start: September 16, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)