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

Inez M Verpalen; Miranda van 't Veer-Ten Kate; Erwin de Boer; Rolf D van den Hoed; Joke M Schutte; Jeroen R Dijkstra; Arie Franx; Lambertus W Bartels; Chrit T W Moonen; Martijn F Boomsma

doi:10.1007/s00330-020-06780-2

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

Inez M Verpalen, Miranda van 't Veer-Ten Kate, Erwin de Boer, Rolf D van den Hoed, Joke M Schutte, Jeroen R Dijkstra, Arie Franx, Lambertus W Bartels, Chrit T W Moonen, Martijn F Boomsma

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	3869-3878
Number of pages	10
Journal	European Radiology
Volume	30
Issue number	7
DOIs	https://doi.org/10.1007/s00330-020-06780-2
Publication status	Published - 1 Jul 2020

Keywords

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

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10.1007/s00330-020-06780-2

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Verpalen, I. M., van 't Veer-Ten Kate, M., de Boer, E., van den Hoed, R. D., Schutte, J. M., Dijkstra, J. R., Franx, A., Bartels, L. W., Moonen, C. T. W., & Boomsma, M. F. (2020). Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids. European Radiology, 30(7), 3869-3878. https://doi.org/10.1007/s00330-020-06780-2

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title = "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.",

keywords = "Uterine fibroids, MR-guided interventional procedures, High-intensity focused ultrasound ablation, Patient selection",

author = "Verpalen, {Inez M} and {van 't Veer-Ten Kate}, Miranda and {de Boer}, Erwin and {van den Hoed}, {Rolf D} and Schutte, {Joke M} and Dijkstra, {Jeroen R} and Arie Franx and Bartels, {Lambertus W} and Moonen, {Chrit T W} and Boomsma, {Martijn F}",

year = "2020",

month = jul,

day = "1",

doi = "10.1007/s00330-020-06780-2",

language = "English",

volume = "30",

pages = "3869--3878",

journal = "European Radiology",

issn = "0938-7994",

publisher = "Springer-Verlag",

number = "7",

}

Verpalen, IM, van 't Veer-Ten Kate, M, de Boer, E, van den Hoed, RD, Schutte, JM, Dijkstra, JR, Franx, A, Bartels, LW , Moonen, CTW & Boomsma, MF 2020, 'Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids', European Radiology, vol. 30, no. 7, pp. 3869-3878. https://doi.org/10.1007/s00330-020-06780-2

TY - JOUR

T1 - Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids

AU - Verpalen, Inez M

AU - van 't Veer-Ten Kate, Miranda

AU - de Boer, Erwin

AU - van den Hoed, Rolf D

AU - Schutte, Joke M

AU - Dijkstra, Jeroen R

AU - Franx, Arie

AU - Bartels, Lambertus W

AU - Moonen, Chrit T W

AU - Boomsma, Martijn F

PY - 2020/7/1

Y1 - 2020/7/1

N2 - 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.

AB - 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.

KW - Uterine fibroids

KW - MR-guided interventional procedures

KW - High-intensity focused ultrasound ablation

KW - Patient selection

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U2 - 10.1007/s00330-020-06780-2

DO - 10.1007/s00330-020-06780-2

M3 - Article

C2 - 32166489

SN - 0938-7994

VL - 30

SP - 3869

EP - 3878

JO - European Radiology

JF - European Radiology

IS - 7

ER -

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

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