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

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

Interventions

DEVICE

Microwave treatment

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

PROCEDURE

uterine artery embolization

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

Sponsors & Collaborators

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Helena Kopp Kallner, MD, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-23

Primary Completion

2019-12-31

Completion

2020-02-29

Countries

• Sweden

Study Locations