Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

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Brief Title

Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

Official Title

Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

Brief Summary

      MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and
      effective method in treating uterine fibroids and also adenomyosis. However, systematic
      studies on the effect of this treatment on factors affecting fertility are still lacking.
      Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this
      study is to obtain more information on the systemic response of the body to the
      HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU
      on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis
      suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be
      assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12
      months after treatment. Blood, urine and endometrium samples will be collected pre- and
      postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these
      samples detailed analysis of the immunological, inflammatory and hormonal response will be
      performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis
      using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine
      disorders will be published, and a key tool in assessing the treatment outcome would be the
      UFS-QoL questionnaire.

      Also new methods for improving patient selection as well as treatment efficacy will be
      evaluated in this study.

Study Type

Interventional

Primary Outcome

Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score

Condition

Uterine Fibroids

Intervention

MRI-HIFU

Study Arms / Comparison Groups

 Patients treated with MRI-HIFU
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

500

Start Date

January 2016

Completion Date

December 2025

Primary Completion Date

December 2025

Eligibility Criteria

        Inclusion Criteria:

          -  BMI < 35

          -  Premenopausal

          -  Uterine size <20 gw

          -  Willingness to participate to the research

          -  Uterine fibroids with typical symptoms

          -  Maximum of 4 treated fibroids

          -  Dominant fibroid >2.5cm

          -  >50% of the fibroid is treatable

        Exclusion criteria

          -  Unspecified pelvic tumours or ovarian masses, PID

          -  Major corrective surgery to uterus (simple myomectomy excluded)

          -  Major uterine anomalies

          -  Unability to calculate the volume of uterine fibroids

          -  Marked uterine calcification

          -  Marked scarring of the lower abdomen

          -  Suspicion of malignancy

          -  Marked general health problem contraindicating MRI

          -  Claustrophobia

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kirsi M Joronen, PhD, , [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations

NCT ID

NCT02914704

Organization ID

GYN-HIFU

Responsible Party

Sponsor

Study Sponsor

Turku University Hospital

Study Sponsor

Kirsi M Joronen, PhD, Principal Investigator, Turku University Hospital

Verification Date

April 2019