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Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)

Primary Purpose

Menorrhagia, Uterine Bleeding

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
hysterectomy
endometrial ablation
Sponsored by
Agency for Healthcare Research and Quality (AHRQ)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Hysterectomy,, Endometrial ablation,, Ovulatory dysfunctional uterine bleeding,, Anovulatory dysfucntional uterine bleeding,, DUB, Dysfunctional uterine bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition. Exclusion Criteria: Prescreen Age < 18 years Postmenopausal status (or bilateral oophorectomy) Bleeding not considered excessive by woman Desire to retain fertility Refusal to consider surgery Known myoma (from prior examination) Eligibility Screen Lack of willingness to have a gynecologic or ultrasound examination Lack of willingness to be interviewed about bleeding or consider study Pregnancy Prior endometrial resection or ablation Prior myomectomy, myolysis, or hysterectomy Medical History No tentative diagnosis of DUB History of malignancy of vagina, cervix, endometrium, or ovary History of complex endometrial hyperplasia or simple hyperplasia with atypia Current use of tamoxifen < 6 months since onset of excessive uterine bleeding < 9 months since stopping the use of IUD < 9 months since stopping the use of implantable hormone agent < 18 months since stopping use of Depo-Provera < 6 months of anovulatory DUB after reaching euthyroid status for woman with diagnosis of hypothyroidism < 3 months since pathology results indicate presence of endometrial polyp Baseline Gynecologic Examination Enlarged (>= 14 weeks gestational age) uterus Focal bleeding of genital, urinary, or gastrointestinal tract Ultrasound Examination Presence of any submucosal myoma Presence of any myoma >= 3 cm, any location Presence of > 3 myomas, any size or location Presence of endometrial polyp(s) Malignancy of the vagina, cervix, endometrium, or ovary Laboratory and Ancillary Tests FSH level in women ages > 45 years confirming postmenopausal status Abnormal urinary tract or gastrointestinal tract imaging related to uterine bleeding Evidence of cervical cancer (screened by Pap smear in last 12 months and confirmed by colposcopy) Evidence of complex endometrial hyperplasia or simple hyperplasia with atypia or endometrial cancer (endometrial biopsy in last 12 months) Any test value inconsistent with a diagnosis of DUB Any test values, unlikely to change, compromising patient safety for surgery Other Any existing medical condition, unlikely to change, putting patient at excessive risk for surgery Request for prophylactic bilateral oophorectomy by woman aged <45 years Lack of willingness to comply with study requirements Uncooperative behavior Any coexisting condition that may influence a patient's ability to comply with participation Refusal to allow evaluation or follow-up In process of scheduling surgery at time of baseline visit Provisional Eligibility Criteria Refusal of randomization < 3 months of medical management (excluding GnRH agonist therapy) within the past 2 years Ongoing evaluation or treatment for abnormal cervical cytology (including endocervical polyps) Gastrointestinal or urinary tract condition unrelated to uterine bleeding currently being treated Any temporary test value compromising patient safety Any temporary existing medical condition putting patient at excessive risk from surgery Any coexisting condition requiring surgery (except tubal occlusion for any woman or oophorectomy for women >= 45 years of age) Lack of willingness to proceed with surgery at this time Lack of willingness to proceed with surgery likely to result in infertility

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Randomized trial: Impact of surgery on bleeding, pain,
    fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.
    Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.

    Secondary Outcome Measures

    Randomized trial: Impact of surgery on primary outcomes at time points after 1 year, quality of life, activity limitation, sexual functioning, urinary incontinence, surgical complications, additional surgery, resource utilization.

    Full Information

    First Posted
    June 13, 2005
    Last Updated
    June 23, 2005
    Sponsor
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00114088
    Brief Title
    Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)
    Official Title
    Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    5. Study Description

    Brief Summary
    STOP-DUB is a multicenter randomized clinical trial that is assessing the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief.
    Detailed Description
    The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) is a multicenter, randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief. Institutional review board-approved study sites included the coordinating center, chair's office, the American College of Obstetricians and Gynecologists, and 33 clinical centers in the United States and Canada. STOP-DUB enrolled (1) 237 eligible patients for whom medical treatment had not been successful and who were randomized to either hysterectomy or EA; and (2) an observational cohort of 139 patients who were "provisionally ineligible" or who were eligible but did not wish to be randomized. Enrollment began November 25, 1997 and ended June 30, 2001. Randomized women were followed using telephone interviews at least 2 years and observational women were followed a maximum of 6 months. We also collected information on return clinical center visits and hospital bills from the sites directly. The primary outcome addressed by the randomized trial is the impact of surgery on bleeding, pain, fatigue, and the major problem (symptom) that led the woman to seek treatment for her condition, measured 1 year following surgery. Additional outcomes included the impact of surgery at time points after 1 year; changes in quality of life, activity limitation, sexual functioning, and urinary incontinence; surgical complications; additional surgery; and resource utilization. The costs and the relative cost-effectiveness of the two surgeries will be calculated. The main scientific objective for the observational study was to examine changes over time in terms of treatment selected, DUB-related symptoms, and quality of life. Enrolled women signed an informed consent to participate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menorrhagia, Uterine Bleeding
    Keywords
    Hysterectomy,, Endometrial ablation,, Ovulatory dysfunctional uterine bleeding,, Anovulatory dysfucntional uterine bleeding,, DUB, Dysfunctional uterine bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    242 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    hysterectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    endometrial ablation
    Primary Outcome Measure Information:
    Title
    Randomized trial: Impact of surgery on bleeding, pain,
    Title
    fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.
    Title
    Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.
    Secondary Outcome Measure Information:
    Title
    Randomized trial: Impact of surgery on primary outcomes at time points after 1 year, quality of life, activity limitation, sexual functioning, urinary incontinence, surgical complications, additional surgery, resource utilization.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition. Exclusion Criteria: Prescreen Age < 18 years Postmenopausal status (or bilateral oophorectomy) Bleeding not considered excessive by woman Desire to retain fertility Refusal to consider surgery Known myoma (from prior examination) Eligibility Screen Lack of willingness to have a gynecologic or ultrasound examination Lack of willingness to be interviewed about bleeding or consider study Pregnancy Prior endometrial resection or ablation Prior myomectomy, myolysis, or hysterectomy Medical History No tentative diagnosis of DUB History of malignancy of vagina, cervix, endometrium, or ovary History of complex endometrial hyperplasia or simple hyperplasia with atypia Current use of tamoxifen < 6 months since onset of excessive uterine bleeding < 9 months since stopping the use of IUD < 9 months since stopping the use of implantable hormone agent < 18 months since stopping use of Depo-Provera < 6 months of anovulatory DUB after reaching euthyroid status for woman with diagnosis of hypothyroidism < 3 months since pathology results indicate presence of endometrial polyp Baseline Gynecologic Examination Enlarged (>= 14 weeks gestational age) uterus Focal bleeding of genital, urinary, or gastrointestinal tract Ultrasound Examination Presence of any submucosal myoma Presence of any myoma >= 3 cm, any location Presence of > 3 myomas, any size or location Presence of endometrial polyp(s) Malignancy of the vagina, cervix, endometrium, or ovary Laboratory and Ancillary Tests FSH level in women ages > 45 years confirming postmenopausal status Abnormal urinary tract or gastrointestinal tract imaging related to uterine bleeding Evidence of cervical cancer (screened by Pap smear in last 12 months and confirmed by colposcopy) Evidence of complex endometrial hyperplasia or simple hyperplasia with atypia or endometrial cancer (endometrial biopsy in last 12 months) Any test value inconsistent with a diagnosis of DUB Any test values, unlikely to change, compromising patient safety for surgery Other Any existing medical condition, unlikely to change, putting patient at excessive risk for surgery Request for prophylactic bilateral oophorectomy by woman aged <45 years Lack of willingness to comply with study requirements Uncooperative behavior Any coexisting condition that may influence a patient's ability to comply with participation Refusal to allow evaluation or follow-up In process of scheduling surgery at time of baseline visit Provisional Eligibility Criteria Refusal of randomization < 3 months of medical management (excluding GnRH agonist therapy) within the past 2 years Ongoing evaluation or treatment for abnormal cervical cytology (including endocervical polyps) Gastrointestinal or urinary tract condition unrelated to uterine bleeding currently being treated Any temporary test value compromising patient safety Any temporary existing medical condition putting patient at excessive risk from surgery Any coexisting condition requiring surgery (except tubal occlusion for any woman or oophorectomy for women >= 45 years of age) Lack of willingness to proceed with surgery at this time Lack of willingness to proceed with surgery likely to result in infertility
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kay Dickersin, PhD
    Organizational Affiliation
    Brown University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14500057
    Citation
    Dickersin K, Munro M, Langenberg P, Scherer R, Frick KD, Weber AM, Johns A, Peipert JF, Clark M; Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding Research Group. Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB): design and methods. Control Clin Trials. 2003 Oct;24(5):591-609. doi: 10.1016/s0197-2456(03)00023-0.
    Results Reference
    background
    PubMed Identifier
    9732095
    Citation
    Weber AM, Munro MG. Endometrial ablation versus hysterectomy: STOP-DUB. Medscape Womens Health. 1998 May;3(3):3.
    Results Reference
    background
    PubMed Identifier
    19111789
    Citation
    Frick KD, Clark MA, Steinwachs DM, Langenberg P, Stovall D, Munro MG, Dickersin K; STOP-DUB Research Group. Financial and quality-of-life burden of dysfunctional uterine bleeding among women agreeing to obtain surgical treatment. Womens Health Issues. 2009 Jan-Feb;19(1):70-8. doi: 10.1016/j.whi.2008.07.002.
    Results Reference
    derived
    PubMed Identifier
    18055721
    Citation
    Dickersin K, Munro MG, Clark M, Langenberg P, Scherer R, Frick K, Zhu Q, Hallock L, Nichols J, Yalcinkaya TM; Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) Research Group. Hysterectomy compared with endometrial ablation for dysfunctional uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1279-89. doi: 10.1097/01.AOG.0000292083.97478.38. Erratum In: Obstet Gynecol. 2008 Aug;112(2 Pt 1):381.
    Results Reference
    derived

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    Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)

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