Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
630 participants
INTERVENTIONAL
2008-11-30
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No UDS
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.
Office evaluation
Office evaluation
UDS
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation with preoperative urodynamic studies prior to surgery.
Office evaluation
Office evaluation
UDS
Urodynamics
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Office evaluation
Office evaluation
UDS
Urodynamics
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Predominant SUI as evidenced by all of the following:
1. Self-reported stress-type UI symptoms, of duration \>3 months\*
2. MESA stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
3. Observation of leakage by provocative stress test at any volume
4. Eligible for randomization to either treatment group
5. Eligible for SUI surgery
6. Desires non-conservative therapy for SUI
7. PVR \<150ml by any method. (May repeat once if initial measure is abnormal)
8. Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture
9. Available to initiate SUI treatment within 6 weeks of randomization
10. Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
11. Signed consent form.
* Patient can be rescreened after respective time interval has been met.
Exclusion Criteria
2. Currently undergoing or has had recommended treatment of apical or anterior prolapse
3. No anterior or apical prolapse \> +1 on standing straining prolapse exam
4. Pregnant or has not completed child bearing.
5. \<12 months post-partum\*†
6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage
7. History of pelvic radiation therapy
8. Previous incontinence surgery
9. Current catheter use
10. Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
11. Previous (i.e. repaired) or current urethral diverticulum
12. Prior augmentation cystoplasty or artificial sphincter
13. Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
14. Any pelvic surgery within the last 3 months\*
15. Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
16. Participation in another treatment intervention trial that might influence results of this trial.
17. A urodynamic result reviewed by the investigator in the preceding 12 months or any recollection by the investigator of urodynamic results on that subject.
* Patient can be rescreened after respective time interval has been met.
* "Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
21 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
University of California, San Diego
OTHER
University of Maryland
OTHER
University of Pittsburgh
OTHER
University of Texas Southwestern Medical Center
OTHER
The University of Texas Health Science Center at San Antonio
OTHER
University of Utah
OTHER
Beaumont Hospital
OTHER
Loyola University
OTHER
Carelon Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ann Gormley, MD
Role: STUDY_CHAIR
Dartmouth-Hitchcock Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama
Birmingham, Alabama, United States
University of California
San Diego, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Oakwood Hospital/Cancer Center
Dearborn, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, Sirls LT, Norton PA, Arisco AM, Chai TC, Zimmern P, Barber MD, Dandreo KJ, Menefee SA, Kenton K, Lowder J, Richter HE, Khandwala S, Nygaard I, Kraus SR, Johnson HW, Lemack GE, Mihova M, Albo ME, Mueller E, Sutkin G, Wilson TS, Hsu Y, Rozanski TA, Rickey LM, Rahn D, Tennstedt S, Kusek JW, Gormley EA; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012 May 24;366(21):1987-97. doi: 10.1056/NEJMoa1113595. Epub 2012 May 2.
Nager CW, Brubaker L, Daneshgari F, Litman HJ, Dandreo KJ, Sirls L, Lemack GE, Richter HE, Leng W, Norton P, Kraus SR, Chai TC, Chang D, Amundsen CL, Stoddard AM, Tennstedt SL; Urinary Incontinence Treatment Network. Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations. Contemp Clin Trials. 2009 Nov;30(6):531-9. doi: 10.1016/j.cct.2009.07.001. Epub 2009 Jul 25.
Norton PA, Nager CW, Brubaker L, Lemack GE, Sirls LT, Holley R, Chai TC, Kraus SR, Zyczynski H, Smith B, Stoddard A; Urinary Incontinence Treatment Network. The cost of preoperative urodynamics: A secondary analysis of the ValUE trial. Neurourol Urodyn. 2016 Jan;35(1):81-4. doi: 10.1002/nau.22684. Epub 2014 Oct 18.
Related Links
Access external resources that provide additional context or updates about the study.
UITN Public Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ValUE (completed)
Identifier Type: -
Identifier Source: org_study_id