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MenorrhagiaPhase 3NCT00114088

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

A Phase 3 study testing hysterectomy and endometrial ablation in people with Menorrhagia and Uterine Bleeding, run by Agency for Healthcare Research and Quality (AHRQ).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Menorrhagia, Uterine Bleeding
What is being tested?
hysterectomy and endometrial ablation
Type of treatment
Surgery or procedure
How many people
242 participants
Where
No sites listed yet
Study dates
Nov 1997to Jan 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition.

Who cannot join

  • Prescreen
  • Age < 18 years
  • Postmenopausal status (or bilateral oophorectomy)
  • Bleeding not considered excessive by woman
  • Desire to retain fertility
  • Refusal to consider surgery
Show all 58Show fewer
  • 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

About this study

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.

Read the 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.

Being tested
hysterectomy, endometrial ablation
Keywords
Hysterectomy,, Endometrial ablation,, Ovulatory dysfunctional uterine bleeding,, Anovulatory dysfucntional uterine bleeding,, DUB, Dysfunctional uterine bleeding
Medical subject headings
Menorrhagia, Uterine Hemorrhage, Metrorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hysterectomyProcedure or surgery

  • endometrial ablationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Randomized trial: Impact of surgery on bleeding, pain,

  2. fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.

  3. Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.

Secondary outcomes (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2005 (estimated)
  2. Study startNov 1997
  3. Study completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
242 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114088
Sponsor's protocol ID
5U01HS009506
Status last verified
Jun 2005
First submitted
13 Jun 2005
Last updated
24 Jun 2005
Results posted
No

Publications

  • 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.

    PubMed 14500057

  • Weber AM, Munro MG. Endometrial ablation versus hysterectomy: STOP-DUB. Medscape Womens Health. 1998 May;3(3):3.

    PubMed 9732095

  • 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.

    PubMed 19111789

  • 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.

    PubMed 18055721

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hysterectomy and endometrial ablation in people with Menorrhagia and Uterine Bleeding, run by Agency for Healthcare Research and Quality (AHRQ).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomized trial: Impact of surgery on bleeding, pain,. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114088, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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