The Journal of Minimally Invasive Gynecology
Volume 17, Issue 1 , Pages 82-90, January 2010

Clinical Evaluation of a Third-Generation Thermal Uterine Balloon Therapy System for Menorrhagia Coupled with Curettage

  • Jose Garza-Leal, MD

      Affiliations

    • Department of Obstetrics and Gynecology, Dr. Jose E. Gonzalez University Hospital, Monterrey, Mexico
    • Corresponding Author InformationCorresponding author: Jose Garza-Leal, MD, Department of Obstetrics and Gynecology, Dr. Jose Eleuterio Gonzalez University Hospital, Ave Francisco I. Madero y Ave, Colonia Mitras Centro; Monterrey, Nuevo Leon 64460, Mexico.
    • ,
  • Alex Pena, MD

      Affiliations

    • Orlando Regional Healthcare System, Physician's Associates, LLC, Orlando, Florida
    • ,
  • Arthur Donovan, MD

      Affiliations

    • HealthSouth Surgicenter of Louisville, Bluegrass Clinical Research Inc., Louisville, Kentucky
    • ,
  • Charles Cash Jr., MD

      Affiliations

    • Department of Obstetrics and Gynecology, Center for Women's Health, Oakwood Hospital and Medical Center, Dearborn, Michigan
    • ,
  • Christine Romanowski, MD

      Affiliations

    • Department of Clinical Development, Ethicon, Inc., Somerville, New Jersey
    • ,
  • Bogdan Ilie, MS

      Affiliations

    • Department of Biostatistics, Ethicon, Inc., Somerville, New Jersey
    • ,
  • Linda Lin, MS

      Affiliations

    • Department of Biostatistics, Ethicon, Inc., Somerville, New Jersey

Received 3 July 2009; received in revised form 25 October 2009; accepted 29 October 2009.

Abstract 

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.

Keywords: Menorrhagia, Thermal uterine balloon therapy(UBT) system, Endometrial ablation

To access this article, please choose from the options below

Login to an existing account or Register a new account.

  • Purchase this article for 31.50 USD (You must login/register to purchase this article)

    Online access for 24 hours. The PDF version can be downloaded as your permanent record.

  • Subscribe to this title

    Get unlimited online access to this article and all other articles in this title 24/7 for one year.

  • Claim access now

    For current subscribers with Society Membership or Account Number.

  • Visit SciVerse ScienceDirect to see if you have access via your institution.
 

 Drs. Garza-Leal, Pena, Donovan, and Cash have no commercial, proprietary, or financial interest in the products or companies described in this article.

 Dr. Romanowski, Mr. Ilie, and Ms. Lin are employees of Ethicon, Inc.

 Presented in part at the 35th Annual Global Conference, AAGL (Advancing Minimally Invasive Gynecology Worldwide) of the American Association of Gynecologic Laparoscopists, Chicago, Illinois, November 2006.

 This study was sponsored by Ethicon, Inc.

PII: S1553-4650(09)01241-2

doi:10.1016/j.jmig.2009.10.016

The Journal of Minimally Invasive Gynecology
Volume 17, Issue 1 , Pages 82-90, January 2010

Article Tools

* Image Usage & Resolution