Minimal Invasive versus Non Invasive treatment for symptomatic uterine fibroids: A randomized controlled trial comparing uterine artery embolization with magnetic resonance guided focused ultrasound (MINI TRIAL)

Withdrawn

• Conditions: uterine fibroids; uterine leiomyoma; 10046828

• Registration Number: NL-OMON35027
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 74

Inclusion Criteria

-Minimum age of 18 years
-Patient is pre- or peri-menopausal
-Diagnosis of uterine fibroids is confirmed with MRI
-Patient suffers from symptomatic uterine fibroids (defined as a minimum Symptom Severity Score of 40 points)
-Patient must provide written informed consent

Exclusion Criteria

-Uterine size larger than 24 weeks of gestation
-Dominant fibroid < 3 cm or > 12 cm diameter
-Pedunculated uterine fibroids with a stalk diameter less than one third of the fibroid diameter (MRI)
-Current pregnancy or desire for future pregnancy
-Suspected gynaecologic malignancy
-Extensive scarring along anterior lower abdominal wall
-Scar tissue or surgical clips in the direct path of the FUS beam
-Current gynaecologic infection
-Presence of intra uterine device
-Degenerated or calcified fibroids (evidenced by gadolinium non-enhancement on MRI)
-Contra-indications for MRI scanning (e.g. pacemaker, severe claustrophobia, ferromagnetic objects in the body)
-Contra-indications for the use of gadolinium based contrast agents (e.g. known allergy, or acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2))
-Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participating patient as judged by the treating physician or the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the MINI-trial is to determine whether recovery is<br /><br>quicker following MRgFUS than UAE. We measure recovery by using 2<br /><br>questionnaires (QoR-40 and RI-10) and we determine the number of days needed to<br /><br>return to work and normal activities. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-quality of life<br /><br>-symptom improvement<br /><br>-pain experience<br /><br>-complications<br /><br>-sexual functioning<br /><br>-additional interventions<br /><br>-ovarian function<br /><br>-cost-effectiveness</p><br>