The objective of the MINI-trial is to compare the clinical effectiveness, quality of life, and cost-effectiveness of uterine artery embolisation (UAE) to MR guided focused ultrasound (MRgFUS) in pre- or perimenopausal women with symptomatic uterine…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
-quality of life
-symptom improvement
-pain experience
-complications
-sexual functioning
-additional interventions
-ovarian function
-cost-effectiveness
Background summary
Uterine fibroids are common benign tumours in premenopausal women. Symptomatic
fibroids influence women's health and quality of life in a negative way. A lot
of women nowadays prefer a minimal invasive treatment over a surgical approach.
The recovery is quicker and the complication rate is lower. Uterine artery
embolization is a minimal invasive treatment with good clinical results.
However, during the treatment and the post-treatment period pain experience can
be very painful and prolong recovery. MR guided focused ultrasoudn (MRgFUS) is
a new, completely non-invasive procedure for fibroids. MRgFUS uses
ultrasoundwaves that ablate fibroid tissue in a specific location. The
treatment is well tolerated and is performed in an outpatient setting. Recovery
is quick and the complication risk is low.
Study objective
The objective of the MINI-trial is to compare the clinical effectiveness,
quality of life, and cost-effectiveness of uterine artery embolisation (UAE) to
MR guided focused ultrasound (MRgFUS) in pre- or perimenopausal women with
symptomatic uterine fibroids.
Study design
Randomized controlled trial comparing MRgFUS with UAE. Patients will be
randomized in a 1:1 ratio.
Intervention
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 (50-70 degrees Celsius) very
precisely in a specific target location. This results in well demarcated ares
of necrosis within the focal area. Multiple ultrasound exposures are necessary
to ablate the targeted tissue. Tight focusing is developed to limit the
ablation to the targeted area.
Applying FUS energy to a fibroid requires treatment planning, targetting of the
ultrasound beam to desired locations and monitoring of the energy delivery.
MR-imaging provides anatomical details and helps with procedure planning and
treatment targeting, including 3D-planning and methods for measuring the
temperature increase generated by MRgFUS.
Study burden and risks
Screening:
-questionnaire symptoms and quality of life
-contrast enhanced MRI in prone position
-gynaecological and physical examination
Baseline:
-several questionnaires
-bloed tests + pregnancy test
Treatment MRgFUS:
-intravenous catheter
-catheter
-prone position in MRI scan during the procedure (max 4 hours)
-after treatment 2 hours observation before discharge
Treatment UAE:
-intravenous catheter
-profylactic antibiotics
-catheter
-PCA pump
-duration of procedure approximately 1,5 uur
-hospital stay for minimum of 1 night
Follow-up:
-patient diary
-2x visit gynaecologist
-2x contrast enhanced MRI scan
-2x bloed test
-questionnaires
Risks of MRgFUS:
-Potential complications after MRgFUS are nausea, pain, abdominal tenderness,
and leg and buttock pain
-Less potential complications are swelling, urinary tract infection, abdominal
cramping and internal tissue thermal injury
-Very rarely seen complications are first degree skin burns, sciatic nerve
damage, pain not reacting to drugs, vomiting, above baseline bleeding, injury
to abdominal and pelvic organs (bladder, uterus, intestine), adverse drug
reactions (gadolinium), fever due to infection. These complications are very
rare.
-Unlikely complications are 2nd and 3rd degree skin burns.
Heidelberglaan 100
3584CX Utrecht
Nederland
Heidelberglaan 100
3584CX Utrecht
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30162.008.09 |