Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial

T Justin Clark; Nadia Samuel; Sadia Malick; Lee J Middleton; Jane Daniels; Janesh K Gupta

doi:10.1097/AOG.0b013e3182020401

Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial

T Justin Clark, Nadia Samuel, Sadia Malick, Lee J Middleton, Jane Daniels, Janesh K Gupta

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

36 Citations (Scopus)

Abstract

OBJECTIVE: To estimate the feasibility of local anesthetic endometrial ablation in the office using bipolar radiofrequency endometrial ablation or thermal balloon ablation technologies and to estimate which procedure alleviates heavy menstrual bleeding and improves quality of life more effectively.

METHODS: A single-center, single-blind, randomized controlled trial was conducted based in an office hysteroscopy clinic in a university teaching hospital. Eighty-one women with heavy menstrual bleeding without significant intracavity pathology were randomly allocated to bipolar radiofrequency endometrial ablation or thermal balloon ablation in an office setting, avoiding use of general anesthesia or conscious sedation. The primary outcome assessed was the rate of amenorrhea at 6 months after treatment. Secondary outcomes included procedure-related data (feasibility, pain, acceptability, complications) and health-related quality of life.

RESULTS: Amenorrhea rates were higher at 6 months after surgery with bipolar procedures, but not statistically significant (39% compared with 21%, risk ratio 1.9, 95% confidence interval 0.9-4.3, P=.1). All bipolar procedures were successfully completed, whereas the treatment cycle was not completed in 2 of 39 (5%) balloon procedures (P>.1) because of patient discomfort. The office bipolar procedure was significantly shorter, by 6.2 minutes on average (P<.001), and associated with more complete coverage of the endometrial surface (88% compared with 58%, P=.002). Health-related quality of life was significantly improved after both treatments.

CONCLUSION: Office endometrial ablation using the bipolar radiofrequency or thermal balloon procedures is feasible and effective. The bipolar procedure was significantly quicker and achieved a greater degree of endometrial destruction than the thermal balloon, although there was no significant difference in amenorrhea rates at 6 months.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357.

LEVEL OF EVIDENCE: I.

Original language	English
Pages (from-to)	109-18
Number of pages	10
Journal	Obstetrics and gynecology
Volume	117
Issue number	1
DOIs	https://doi.org/10.1097/AOG.0b013e3182020401
Publication status	Published - Jan 2011

Keywords

Adult
Endometrial Ablation Techniques
Feasibility Studies
Female
Humans
Menorrhagia
Middle Aged
Treatment Outcome

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10.1097/AOG.0b013e3182020401

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title = "Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial",

abstract = "OBJECTIVE: To estimate the feasibility of local anesthetic endometrial ablation in the office using bipolar radiofrequency endometrial ablation or thermal balloon ablation technologies and to estimate which procedure alleviates heavy menstrual bleeding and improves quality of life more effectively.METHODS: A single-center, single-blind, randomized controlled trial was conducted based in an office hysteroscopy clinic in a university teaching hospital. Eighty-one women with heavy menstrual bleeding without significant intracavity pathology were randomly allocated to bipolar radiofrequency endometrial ablation or thermal balloon ablation in an office setting, avoiding use of general anesthesia or conscious sedation. The primary outcome assessed was the rate of amenorrhea at 6 months after treatment. Secondary outcomes included procedure-related data (feasibility, pain, acceptability, complications) and health-related quality of life.RESULTS: Amenorrhea rates were higher at 6 months after surgery with bipolar procedures, but not statistically significant (39% compared with 21%, risk ratio 1.9, 95% confidence interval 0.9-4.3, P=.1). All bipolar procedures were successfully completed, whereas the treatment cycle was not completed in 2 of 39 (5%) balloon procedures (P>.1) because of patient discomfort. The office bipolar procedure was significantly shorter, by 6.2 minutes on average (P<.001), and associated with more complete coverage of the endometrial surface (88% compared with 58%, P=.002). Health-related quality of life was significantly improved after both treatments.CONCLUSION: Office endometrial ablation using the bipolar radiofrequency or thermal balloon procedures is feasible and effective. The bipolar procedure was significantly quicker and achieved a greater degree of endometrial destruction than the thermal balloon, although there was no significant difference in amenorrhea rates at 6 months.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357.LEVEL OF EVIDENCE: I.",

keywords = "Adult, Endometrial Ablation Techniques, Feasibility Studies, Female, Humans, Menorrhagia, Middle Aged, Treatment Outcome",

author = "Clark, {T Justin} and Nadia Samuel and Sadia Malick and Middleton, {Lee J} and Jane Daniels and Gupta, {Janesh K}",

year = "2011",

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doi = "10.1097/AOG.0b013e3182020401",

language = "English",

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pages = "109--18",

journal = "Obstetrics and gynecology",

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T1 - Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office

T2 - a randomized controlled trial

AU - Clark, T Justin

AU - Samuel, Nadia

AU - Malick, Sadia

AU - Middleton, Lee J

AU - Daniels, Jane

AU - Gupta, Janesh K

PY - 2011/1

Y1 - 2011/1

N2 - OBJECTIVE: To estimate the feasibility of local anesthetic endometrial ablation in the office using bipolar radiofrequency endometrial ablation or thermal balloon ablation technologies and to estimate which procedure alleviates heavy menstrual bleeding and improves quality of life more effectively.METHODS: A single-center, single-blind, randomized controlled trial was conducted based in an office hysteroscopy clinic in a university teaching hospital. Eighty-one women with heavy menstrual bleeding without significant intracavity pathology were randomly allocated to bipolar radiofrequency endometrial ablation or thermal balloon ablation in an office setting, avoiding use of general anesthesia or conscious sedation. The primary outcome assessed was the rate of amenorrhea at 6 months after treatment. Secondary outcomes included procedure-related data (feasibility, pain, acceptability, complications) and health-related quality of life.RESULTS: Amenorrhea rates were higher at 6 months after surgery with bipolar procedures, but not statistically significant (39% compared with 21%, risk ratio 1.9, 95% confidence interval 0.9-4.3, P=.1). All bipolar procedures were successfully completed, whereas the treatment cycle was not completed in 2 of 39 (5%) balloon procedures (P>.1) because of patient discomfort. The office bipolar procedure was significantly shorter, by 6.2 minutes on average (P<.001), and associated with more complete coverage of the endometrial surface (88% compared with 58%, P=.002). Health-related quality of life was significantly improved after both treatments.CONCLUSION: Office endometrial ablation using the bipolar radiofrequency or thermal balloon procedures is feasible and effective. The bipolar procedure was significantly quicker and achieved a greater degree of endometrial destruction than the thermal balloon, although there was no significant difference in amenorrhea rates at 6 months.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357.LEVEL OF EVIDENCE: I.

AB - OBJECTIVE: To estimate the feasibility of local anesthetic endometrial ablation in the office using bipolar radiofrequency endometrial ablation or thermal balloon ablation technologies and to estimate which procedure alleviates heavy menstrual bleeding and improves quality of life more effectively.METHODS: A single-center, single-blind, randomized controlled trial was conducted based in an office hysteroscopy clinic in a university teaching hospital. Eighty-one women with heavy menstrual bleeding without significant intracavity pathology were randomly allocated to bipolar radiofrequency endometrial ablation or thermal balloon ablation in an office setting, avoiding use of general anesthesia or conscious sedation. The primary outcome assessed was the rate of amenorrhea at 6 months after treatment. Secondary outcomes included procedure-related data (feasibility, pain, acceptability, complications) and health-related quality of life.RESULTS: Amenorrhea rates were higher at 6 months after surgery with bipolar procedures, but not statistically significant (39% compared with 21%, risk ratio 1.9, 95% confidence interval 0.9-4.3, P=.1). All bipolar procedures were successfully completed, whereas the treatment cycle was not completed in 2 of 39 (5%) balloon procedures (P>.1) because of patient discomfort. The office bipolar procedure was significantly shorter, by 6.2 minutes on average (P<.001), and associated with more complete coverage of the endometrial surface (88% compared with 58%, P=.002). Health-related quality of life was significantly improved after both treatments.CONCLUSION: Office endometrial ablation using the bipolar radiofrequency or thermal balloon procedures is feasible and effective. The bipolar procedure was significantly quicker and achieved a greater degree of endometrial destruction than the thermal balloon, although there was no significant difference in amenorrhea rates at 6 months.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357.LEVEL OF EVIDENCE: I.

KW - Adult

KW - Endometrial Ablation Techniques

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Menorrhagia

KW - Middle Aged

KW - Treatment Outcome

U2 - 10.1097/AOG.0b013e3182020401

DO - 10.1097/AOG.0b013e3182020401

M3 - Article

C2 - 21173651

SN - 0029-7844

VL - 117

SP - 109

EP - 118

JO - Obstetrics and gynecology

JF - Obstetrics and gynecology

IS - 1

ER -

Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial

Abstract

Keywords

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