Document Detail

Clinical Evaluation of Long-term Safety and Effectiveness of a Third-Generation Thermal Uterine Balloon Therapy System for Heavy Menstrual Bleeding.
MedLine Citation:
PMID:  22748952     Owner:  NLM     Status:  In-Data-Review    
STUDY OBJECTIVES: To estimate the incidence of amenorrhea at 36 months after treatment using a third-generation thermal uterine balloon therapy (UBT) system and to compare it with the first-generation UBT system. The secondary objective was to estimate the effect of post-procedure curettage on patient outcomes at 36 months after endometrial ablation.
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 at least 30 years with heavy menstrual bleeding 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 post-procedure curettage (PPC) or no PPC.
MEASUREMENTS AND MAIN RESULTS: Amenorrhea was estimated at 12 months using individual success defined by a pictorial blood loss assessment chart score of 0, and at 24- and 36-month follow-up by patient response of amenorrhea on a 5-point scale (amenorrhea, spotting, and light, normal, or excessive bleeding). In the intention-to-treat population, at 36 months after ablation, the amenorrhea rate was 26.8% with the third-generation UBT system, and 13.0% with the first-generation UBT system. Results by assigned intervention were 29.8% in the no PPC group vs 23.8% in the PPC group.
CONCLUSION: At extended 36-month follow-up, results were similar to the previously reported results at 1 year using prospectively defined matched-pair analysis, and demonstrated superiority in treating amenorrhea using the third-generation UBT system vs the first-generation UBT system.
Charles Cash; Jose Garza-Leal; Arthur Donovan; Cyrus Guidry; Christine Romanowski; Bababhai Patel
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of minimally invasive gynecology     Volume:  19     ISSN:  1553-4669     ISO Abbreviation:  J Minim Invasive Gynecol     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-03     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101235322     Medline TA:  J Minim Invasive Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  469-76     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.
Center for Women's Health, Oakwood Hospital and Medical Center, Department of Obstetrics and Gynecology, Dearborn, Michigan.
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