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

Sponsor

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00114088

Collaborator

(none)

242

Enrollment

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia Uterine Bleeding	Procedure: hysterectomy Procedure: endometrial ablation	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 1997

Study Completion Date :

Jan 1, 2004

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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