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Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids

Abstract

Objectives

The clinical applicability of magnetic resonance image−guided high-intensity focused ultrasound (MR-HIFU) treatment of uterine fibroids is often limited due to inaccessible fibroids or bowel interference. The aim of this study was to implement a newly developed 3-step modified manipulation protocol and to evaluate its influence on the number of eligible women and treatment failure rate.

Methods

From June 2016 to June 2018, 165 women underwent a screening MRI examination, 67 women of whom were consecutively treated with MR-HIFU at our institution. Group 1 (n = 20) was treated with the BRB manipulation protocol which consisted of sequential applications of urinary bladder filling, rectal filling, and urinary bladder emptying. Group 2 (n = 47) was treated using the 3-step modified manipulation protocol which included (1) the BRB maneuver with adjusted rectal filling by adding psyllium fibers to the solution; (2) Trendelenburg position combined with bowel massage; (3) the manual uterine manipulation (MUM) method for uterine repositioning. A comparison was made between the two manipulation protocols to evaluate differences in safety, the eligibility percentage, and treatment failure rate due to unsuccessful manipulation.

Results

After implementing the 3-step modified manipulation protocol, our ineligibility rate due to bowel interference or inaccessible fibroids decreased from 18% (16/88) to 0% (0/77). Our treatment failure rate due to unsuccessful manipulation decreased from 20% (4/20) to 2% (1/47). There were no thermal complications to the bowel or uterus.

Conclusions

Implementation of the 3-step modified manipulation protocol during MR-HIFU therapy of uterine fibroids improved the eligibility percentage and reduced the treatment failure rate.

Trial registration

Registry number NL56182.075.16

Key Points

• A newly developed 3-step modified manipulation protocol was successfully implemented without the occurrence of thermal complication to the bowel or uterus.

• The 3-step modified manipulation protocol increased our eligibility percentage for MR-HIFU treatment of uterine fibroids.

• The 3-step modified manipulation protocol reduced our treatment failure rate for MR-HIFU treatment of uterine fibroids.

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Abbreviations

BRB:

Bladder filling, rectal filling, bladder emptying

CE:

Contrast-enhanced

MR-HIFU:

Magnetic resonance image–guided high-intensity focused ultrasound

MRI:

Magnetic resonance imaging

MUM:

Manual uterine manipulation

NPV:

Non-perfused volume

SI:

Signal intensity

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Funding

The authors state that this work has not received any funding.

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Authors and Affiliations

Authors

Corresponding author

Correspondence to Inez M. Verpalen.

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Guarantor

The scientific guarantor of this publication is M.F. Boomsma, MD, PhD.

Conflict of interest

The authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.

Statistics and biometry

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• Prospective

• Experimental

• Performed at one institution

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Verpalen, I.M., van ‘t Veer-ten Kate, M., de Boer, E. et al. Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids. Eur Radiol 30, 3869–3878 (2020). https://doi.org/10.1007/s00330-020-06780-2

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  • DOI: https://doi.org/10.1007/s00330-020-06780-2

Keywords

  • Uterine fibroids
  • MR-guided interventional procedures
  • High-intensity focused ultrasound ablation
  • Patient selection