Document Detail

Clinical evaluation of a third-generation thermal uterine balloon therapy system for menorrhagia coupled with curettage.
MedLine Citation:
PMID:  20129336     Owner:  NLM     Status:  MEDLINE    
STUDY OBJECTIVES: 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. DESIGN: Multicenter, controlled study (Canadian Task Force classification I). SETTING: Thirteen hospitals: 12 in the United States and 1 in Mexico. PATIENTS: Two hundred fifty premenopausal women aged 30 years or older with menorrhagia not responsive to previous medical therapy for at least 3 months. INTERVENTION: After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive postprocedure curettage or no further treatment. MEASUREMENTS AND MAIN 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. CONCLUSION: 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.
Jose Garza-Leal; Alex Pena; Arthur Donovan; Charles Cash; Christine Romanowski; Bogdan Ilie; Linda Lin
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of minimally invasive gynecology     Volume:  17     ISSN:  1553-4650     ISO Abbreviation:  J Minim Invasive Gynecol     Publication Date:    2010 Jan-Feb
Date Detail:
Created Date:  2010-02-04     Completed Date:  2010-03-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101235322     Medline TA:  J Minim Invasive Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  82-90     Citation Subset:  IM    
Copyright Information:
Copyright (c) 2010 AAGL. Published by Elsevier Inc. All rights reserved.
Department of Obstetrics and Gynecology, Dr. Jose E. Gonzalez University Hospital, Monterrey, Mexico.
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MeSH Terms
Balloon Dilatation / instrumentation,  methods*
Follow-Up Studies
Hysteroscopy / methods*
Intention to Treat Analysis
Menorrhagia / surgery*
Patient Satisfaction
Patient Selection
Quality of Life
Severity of Illness Index
Treatment Outcome

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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