Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial

A M Sambrook, A Elders, K G Cooper

Research output: Contribution to journalArticle

7 Citations (Scopus)
3 Downloads (Pure)

Abstract

OBJECTIVE: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall).

DESIGN: Follow up of a prospective, double-blind randomised controlled trial at 5 years.

SETTING: A teaching hospital in the UK.

POPULATION: A total of 320 women eligible for and requesting endometrial ablation.

METHODS: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database.

MAIN OUTCOME MEASURES: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery.

RESULTS: Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%).

CONCLUSIONS: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.

Original languageEnglish
Pages (from-to)747-753; discussion 754
Number of pages7
JournalBJOG-An International Journal of Obstetrics and Gynaecology
Volume121
Issue number6
Early online date10 Feb 2014
DOIs
Publication statusPublished - May 2014

Fingerprint

Endometrial Ablation Techniques
Microwaves
Randomized Controlled Trials
Hot Temperature
Quality of Life
Hysterectomy
Amenorrhea
Treatment Failure
Patient Satisfaction
Teaching Hospitals
Outcome Assessment (Health Care)
Databases
Hemorrhage
Therapeutics

Keywords

  • Adult
  • Amenorrhea
  • Double-Blind Method
  • Endometrial Ablation Techniques
  • Female
  • Follow-Up Studies
  • Great Britain
  • Humans
  • Hysterectomy
  • Microwaves
  • Patient Satisfaction
  • Prospective Studies
  • Quality of Life
  • Questionnaires
  • Treatment Outcome
  • Endometrial Ablation
  • Heavy Menstrual Bleeding
  • Long-Term Follow Up
  • Randomised Controlled Trial

Cite this

Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall) : 5-year follow up of a randomised controlled trial. / Sambrook, A M; Elders, A; Cooper, K G.

In: BJOG-An International Journal of Obstetrics and Gynaecology, Vol. 121, No. 6, 05.2014, p. 747-753; discussion 754.

Research output: Contribution to journalArticle

@article{bbb0db4bd542491982547a6b8cc8430a,
title = "Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial",
abstract = "OBJECTIVE: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall).DESIGN: Follow up of a prospective, double-blind randomised controlled trial at 5 years.SETTING: A teaching hospital in the UK.POPULATION: A total of 320 women eligible for and requesting endometrial ablation.METHODS: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database.MAIN OUTCOME MEASURES: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery.RESULTS: Of the women originally randomised 217/314 (69.1{\%}) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58{\%} for MEA™ versus 53{\%} for TBall, difference 5{\%}; 95{\%} CI -6 to 16{\%}). Amenorrhoea rates were high following both techniques (51{\%} versus 45{\%}, difference 6{\%}; 95{\%} CI -5 to 17{\%}). There was no significant difference in the hysterectomy rates between the two arms (9{\%} versus 7{\%}, difference 2{\%}; 95{\%} CI -5 to 9{\%}).CONCLUSIONS: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.",
keywords = "Adult, Amenorrhea, Double-Blind Method, Endometrial Ablation Techniques, Female, Follow-Up Studies, Great Britain, Humans, Hysterectomy, Microwaves, Patient Satisfaction, Prospective Studies, Quality of Life, Questionnaires, Treatment Outcome, Endometrial Ablation, Heavy Menstrual Bleeding, Long-Term Follow Up, Randomised Controlled Trial",
author = "Sambrook, {A M} and A Elders and Cooper, {K G}",
note = "{\circledC} 2014 Royal College of Obstetricians and Gynaecologists.",
year = "2014",
month = "5",
doi = "10.1111/1471-0528.12585",
language = "English",
volume = "121",
pages = "747--753; discussion 754",
journal = "BJOG-An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "John Wiley & Sons, Ltd (10.1111)",
number = "6",

}

TY - JOUR

T1 - Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall)

T2 - 5-year follow up of a randomised controlled trial

AU - Sambrook, A M

AU - Elders, A

AU - Cooper, K G

N1 - © 2014 Royal College of Obstetricians and Gynaecologists.

PY - 2014/5

Y1 - 2014/5

N2 - OBJECTIVE: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall).DESIGN: Follow up of a prospective, double-blind randomised controlled trial at 5 years.SETTING: A teaching hospital in the UK.POPULATION: A total of 320 women eligible for and requesting endometrial ablation.METHODS: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database.MAIN OUTCOME MEASURES: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery.RESULTS: Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%).CONCLUSIONS: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.

AB - OBJECTIVE: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall).DESIGN: Follow up of a prospective, double-blind randomised controlled trial at 5 years.SETTING: A teaching hospital in the UK.POPULATION: A total of 320 women eligible for and requesting endometrial ablation.METHODS: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database.MAIN OUTCOME MEASURES: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery.RESULTS: Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%).CONCLUSIONS: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.

KW - Adult

KW - Amenorrhea

KW - Double-Blind Method

KW - Endometrial Ablation Techniques

KW - Female

KW - Follow-Up Studies

KW - Great Britain

KW - Humans

KW - Hysterectomy

KW - Microwaves

KW - Patient Satisfaction

KW - Prospective Studies

KW - Quality of Life

KW - Questionnaires

KW - Treatment Outcome

KW - Endometrial Ablation

KW - Heavy Menstrual Bleeding

KW - Long-Term Follow Up

KW - Randomised Controlled Trial

U2 - 10.1111/1471-0528.12585

DO - 10.1111/1471-0528.12585

M3 - Article

C2 - 24506529

VL - 121

SP - 747-753; discussion 754

JO - BJOG-An International Journal of Obstetrics and Gynaecology

JF - BJOG-An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 6

ER -