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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)

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) - MINI TRIAL

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35027
Enrollment
74
Registered
2010-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

uterine fibroids uterine leiomyoma

Interventions

Half of the patiens will undergo UAE according to the currently used protocol. The other half of the patients will undergo MRgFUS treatment. An ultrasound beam is used to generate high temperatures (

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -Uterine size larger than 24 weeks of gestation -Dominant fibroid 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

Design outcomes

Primary

MeasureTime frame
The primary objective of the MINI-trial is to determine whether recovery is quicker following MRgFUS than UAE. We measure recovery by using 2 questionnaires (QoR-40 and RI-10) and we determine the number of days needed to return to work and normal activities.—

Secondary

MeasureTime frame
-quality of life -symptom improvement -pain experience -complications -sexual functioning -additional interventions -ovarian function -cost-effectiveness—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)