Study of Volume Reduction of Uterine Fibroids After Embolization or Microwave Treatment

NCT02942537 | Unknown Phase 2 DMC

• 1 other identifier: MYOMIC1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention has been paid to the study of minimally invasive methods for treatment. Microwave ablation of myomas and endometrium has been shown to have good effect and acceptability has been high. This study aims to compare the effectiveness, feasibility and acceptability of percutaneous or per vaginal microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study. Primary outcome 1\. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic Power calculation To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50%\[11\] in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women. In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized. Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist. After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than mean diameter 8cm will be excluded from further participation in the study. All women included in the study after MRI examination will fill in a PBAC evaluation\[7\] during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment. Microwave ablation will be performed percutaneously or vaginally using a Covidien Emprint microwave ablation system. Embolization will be performed in conscious women with an epidural catheter for pain relief. At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend. A new MRI scan will be performed 6 months post treatment (+/-15 days).

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Fibroma Volume reduction 6 months post treatment

  Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic resonance imaging (MRI)

  6 months post treatment (+/-15 days)

Secondary Outcomes (10)

• Pain

  1-7 days post treatment

• Symptoms of uterine fibroids

  pre-treatment-6 months post treatment

• Use of pain medication

  pre-treatment to 6 months post treatment

• Period of sick leave

  post treament to one year

• Period of hospitalization

  post treatment to one year

Study Arms (2)

Intervention

EXPERIMENTAL

Microwave treatment

Device: Microwave treatment

Control

ACTIVE COMPARATOR

Uterine artery embolization

Procedure: uterine artery embolization

Interventions

Microwave treatment DEVICE

Percutaneous or vaginal application of microwave antenna with microwave treatment of fibroma

Intervention

uterine artery embolization PROCEDURE

Percutaneous applicaiton of a catheter into the femoral artery and embolization of uterine artery or branches thereof

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 fibromas (pressure, heaviness, bleeding, urgency)
• Premenopausal
• Fibromas with a maximum mean diameter of cm evaluated by trans vaginal or abdominal ultrasound
• Willing to comply with protocol

You may not qualify if:

• Current or future childwish
• Body Mass Index \>35
• Treatment with anticoagulant
• Bleeding disorder which leads to increased risk of bleeding
• Patients with single fibroid more than 6cm mean diameter according to MRI.
• Contraindication for UAE or general anesthesia

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Dept of Obstetrics and Gynecology, Dnderyds Hospital

Stockholm, 18288, Sweden

RECRUITING

Related Publications (10)

• Kanaoka Y, Yoshida C, Fukuda T, Kajitani K, Ishiko O. Transcervical microwave myolysis for uterine myomas assisted by transvaginal ultrasonic guidance. J Obstet Gynaecol Res. 2009 Feb;35(1):145-51. doi: 10.1111/j.1447-0756.2008.00872.x.

  PMID: 19215562 BACKGROUND

• Zhang J, Feng L, Zhang B, Ren J, Li Z, Hu D, Jiang X. Ultrasound-guided percutaneous microwave ablation for symptomatic uterine fibroid treatment--a clinical study. Int J Hyperthermia. 2011;27(5):510-6. doi: 10.3109/02656736.2011.562872.

  PMID: 21756048 BACKGROUND

• Wang F, Zhang J, Han ZY, Cheng ZG, Zhou HY, Feng L, Hu DM. Imaging manifestation of conventional and contrast-enhanced ultrasonography in percutaneous microwave ablation for the treatment of uterine fibroids. Eur J Radiol. 2012 Nov;81(11):2947-52. doi: 10.1016/j.ejrad.2011.12.037. Epub 2012 Feb 16.

  PMID: 22341698 BACKGROUND

• Yang Y, Zhang J, Han ZY, Yu MA, Ma X, Zhou HY, Hao YL, Zhao L, Dong XJ, Ge HL. Ultrasound-guided percutaneous microwave ablation for submucosal uterine fibroids. J Minim Invasive Gynecol. 2014 May-Jun;21(3):436-41. doi: 10.1016/j.jmig.2013.11.012. Epub 2013 Dec 4.

  PMID: 24316137 BACKGROUND

• Zhao WP, Han ZY, Zhang J, Liang P. A retrospective comparison of microwave ablation and high intensity focused ultrasound for treating symptomatic uterine fibroids. Eur J Radiol. 2015 Mar;84(3):413-417. doi: 10.1016/j.ejrad.2014.11.041. Epub 2014 Dec 15.

  PMID: 25572326 BACKGROUND

• Kanaoka Y, Hirai K, Ishiko O. Microwave endometrial ablation for menorrhagia caused by large submucous myomas. J Obstet Gynaecol Res. 2005 Dec;31(6):565-70. doi: 10.1111/j.1447-0756.2005.00338.x.

  PMID: 16343261 BACKGROUND

• Reid PC, Coker A, Coltart R. Assessment of menstrual blood loss using a pictorial chart: a validation study. BJOG. 2000 Mar;107(3):320-2. doi: 10.1111/j.1471-0528.2000.tb13225.x.

  PMID: 10740326 BACKGROUND

• 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.

  PMID: 11814511 BACKGROUND

• Harding G, Coyne KS, Thompson CL, Spies JB. The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL). Health Qual Life Outcomes. 2008 Nov 12;6:99. doi: 10.1186/1477-7525-6-99.

  PMID: 19014505 BACKGROUND

• Jonsdottir G, Beermann M, Lundgren Cronsioe A, Hasselrot K, Kopp Kallner H. Ultrasound guided microwave ablation compared to uterine artery embolization treatment for uterine fibroids - a randomized controlled trial. Int J Hyperthermia. 2022;39(1):341-347. doi: 10.1080/02656736.2022.2034991.

  PMID: 35134317 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Uterine Artery Embolization

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Helena Kopp Kallner, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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

Study Record Dates

• First Submitted: October 15, 2016
• First Posted: October 24, 2016
• Study Start: January 23, 2017
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

SE (1)