Clinical evaluation of a third-generation thermal uterine balloon therapy system for menorrhagia coupled with curettage.
OBJECTIVE
To estimate the incidence of amenorrhea 12 months after treatment with a third-generation thermal uterine balloon therapy (UBT) system. Secondary objectives were to compare the incidence of amenorrhea observed with this third-generation system with that of a first-generation system, to estimate the effect of postprocedure curettage on patient outcome, and to evaluate the workings of this new system.


METHODS
Multicenter, controlled study (Canadian Task Force classification I).


METHODS
Thirteen hospitals: 12 in the United States and 1 in Mexico.


METHODS
Two hundred fifty premenopausal women aged 30 years or older with menorrhagia not responsive to previous medical therapy for at least 3 months.


METHODS
After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive postprocedure curettage or no further treatment.


RESULTS
The rate of amenorrhea 12 months after treatment with the third-generation thermal UBT system was similar in patients receiving postprocedure curettage (33.3%) and those receiving no further treatment (37.1%; p=.53). In addition, postprocedure curettage did not have any significant effect on any other patient outcome, for example, pain. Patients who were matched to historic control patients treated with the original first-generation system demonstrated a significantly greater success rate (amenorrhea) at 12 months (32.6%) compared with those treated with the first-generation system (13.7%). The third-generation thermal UBT instrument functioned as designed, with no unanticipated adverse device effects.


CONCLUSIONS
The third-generation thermal UBT system shows greater efficacy in producing amenorrhea than the original first-generation system, with no significant safety issues. Postprocedural curettage did not alter amennorhea rates.
Department of Obstetrics and Gynecology, Dr. Jose E. Gonzalez University Hospital, Monterrey, Mexico. drjoseggarza@prodigy.net.mx
Jose
J
Garza-Leal
Alex
A
Pena
Arthur
A
Donovan
Charles
C
Cash
Christine
C
Romanowski
Bogdan
B
Ilie
Linda
L
Lin
D000328:Adult; D002404:Catheterization / Q000295:instrumentation / Q000379:methods*; D003475:Curettage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D057194:Intention to Treat Analysis; D008595:Menorrhagia / Q000601:surgery*; D017060:Patient Satisfaction; D018579:Patient Selection; D011788:Quality of Life; D012008:Recurrence; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome