Evidence map›Paper›PMID 42294814›Full record

Trial reportActa obstetricia et gynecologica Scandinavica2026

Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy of uterine fibroids effectively reduces both bleeding and bulk symptoms-A prospective single-center 12-month follow-up study.

Saara Otonkoski, Antti Viitala, Gaber Komar, Teija Sainio, Anna Yanovskiy, Ina Lehtonen, Roberto Blanco Sequeiros, Antti Perheentupa, Kirsi Joronen

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Acta obstetricia et gynecologica Scandinavica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02914704 (Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02914704 naunknown statusnot on this map

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

TypeinterventionalSponsorTurku University HospitalRan2016 to 2025Enrolled500ConditionsUterine Fibroids, AdenomyosisArmsMRI-HIFU
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Saara OtonkoskiDepartment of Obstetrics and Gynaecology, Turku University Hospital, Turku, Finland.
Antti ViitalaFaculty of Medicine, University of Turku, Turku, Finland.
Gaber KomarFaculty of Medicine, University of Turku, Turku, Finland.
Teija SainioFaculty of Medicine, University of Turku, Turku, Finland.ORCID https://orcid.org/0000-0001-5846-2601
Anna YanovskiyFaculty of Medicine, University of Turku, Turku, Finland.
Ina LehtonenDepartment of Obstetrics and Gynaecology, Turku University Hospital, Turku, Finland.
Roberto Blanco SequeirosFaculty of Medicine, University of Turku, Turku, Finland.
Antti PerheentupaDepartment of Obstetrics and Gynaecology, Turku University Hospital, Turku, Finland.
Kirsi JoronenDepartment of Obstetrics and Gynaecology, Turku University Hospital, Turku, Finland.

Funding

Government Research Foundation of Finland
6 · The paper itself

Abstract

introductionUterine fibroids are common benign neoplasms in women. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) is a noninvasive treatment that has been shown to reduce fibroid-related symptoms and improve quality of life (QoL). In this study, we aimed to clarify symptom reduction in patients with isolated bleeding or bulk symptoms. MATERIAL AND

methodsThis prospective study with a 12-month follow-up included 163 women with uterine fibroids causing either bleeding or bulk symptoms and deemed suitable for MR-HIFU treatment. Treatments were carried out using an extracorporeal tabletop MR-HIFU system (Sonalleve V2, Profound Medical Inc., Mississauga, Canada). The non-perfused volume ratio (NPV%) was determined after treatment. Symptom severity and QoL were assessed using the Uterine Fibroid Symptom and Quality of Life questionnaire at baseline, 3 months, and 12 months after treatment. The study was registered at ClinicalTrials.gov (NCT02914704).

resultsA total of 122 women with bleeding and 41 women with bulk symptoms were included. The overall mean NPV% for all patients was 62%. The median symptom severity score (SSS) at baseline was 56 (IQR 47-69) and 46 (34-63), at 3 months 28 (16-44) and 19 (6-30), and at 12 months 25 (13-31) and 19 (6-41) for the bleeding and bulk groups, respectively. The reduction of SSS was statistically significant between baseline and 3 months (p < 0.001) and between baseline and 12 months (p < 0.001) in both groups. The median of QoL at baseline was 43 (IQR 31-58) and 74 (45-83), at 3 months 70 (53-82) and 89 (74-97), and at 12 months 82 (69-91) and 82 (67-100) for the bleeding and bulk groups, respectively. In the bleeding patients, the increase in QoL was statistically significant between all the time points compared (p < 0.05). In the bulk group, the increase in QoL was statistically significant from baseline to 3 months (p < 0.001) and from baseline to 12 months (p < 0.01).

conclusionsMR-HIFU resulted in significant symptom reduction and improved QoL in patients with both bleeding and bulk-related fibroid symptoms. When successful, MR-HIFU provides effective and rapid symptom relief for both symptom types.

Indexed as

High-Intensity Focused Ultrasound AblationLeiomyomaMagnetic Resonance Imaging, InterventionalUterine HemorrhageUterine NeoplasmsAdultFemaleFollow-Up StudiesHumansMiddle AgedProspective StudiesQuality of LifeTreatment Outcomebleedingbulk symptomsfibroidMR‐HIFUquality of life

Identifiers

PMID42294814
PMCPMC13394642

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.