Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Jan;117(1):109-118.
doi: 10.1097/AOG.0b013e3182020401.

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

T Justin Clark  1 , Nadia Samuel, Sadia Malick, Lee J Middleton, Jane Daniels, Janesh K Gupta
Affiliations
Randomized Controlled Trial

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

T Justin Clark et al. Obstet Gynecol. 2011 Jan.

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.

PubMed Disclaimer

Comment in

References

    1. Peto V, Coulter A, Bond A. Factors affecting general practitioners' recruitment of patients into a prospective study. Fam Pract 1993;10:207–11.
    1. Coulter A, Bradlow J, Agass M, Martin-Bates C, Tulloch A. Outcomes of referrals to gynaecology outpatient clinics for menstrual problems: an audit of general practice records. Br J Obstet Gynaecol 1991;98:789–96.
    1. Garside R, Stein K, Wyatt K, Round A, Price A. The effectiveness and cost-effectiveness of microwave and thermal balloon endometrial ablation for heavy menstrual bleeding: a systematic review and economic modelling. Health Technol Assess 2004;8:iii, 1–155.
    1. Cooper J, Gimpelson RJ. Summary of safety and effectiveness data from FDA: a valuable source of information on the performance of global endometrial ablation devices. J Reprod Med 2004;49:267–73.
    1. Bongers MY, Bourdrez P, Heintz AP, Brölmann HA, Mol BW. Bipolar radio frequency endometrial ablation compared with balloon endometrial ablation in dysfunctional uterine bleeding: impact on patients' health-related quality of life. Fertil Steril 2005;83:724–34.

Publication types

Associated data