- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00803959
Value of Urodynamic Evaluation (ValUE)
July 3, 2013 updated by: HealthCore-NERI
A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age.
UDS is typically performed prior to incontinence surgery.
Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations.
The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
630
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama
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California
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San Diego, California, United States, 92103
- University of California
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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Michigan
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Dearborn, Michigan, United States, 48123
- Oakwood Hospital/Cancer Center
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern
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San Antonio, Texas, United States, 78229-3900
- University of Texas Health Sciences Center
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
Predominant SUI as evidenced by all of the following:
- Self-reported stress-type UI symptoms, of duration >3 months*
- MESA stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
- Observation of leakage by provocative stress test at any volume
- Eligible for randomization to either treatment group
- Eligible for SUI surgery
- Desires non-conservative therapy for SUI
- PVR <150ml by any method. (May repeat once if initial measure is abnormal)
- Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) or negative UA or negative culture
- Available to initiate SUI treatment within 6 weeks of randomization
- Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
Signed consent form.
- Patient can be rescreened after respective time interval has been met.
Exclusion Criteria:
- Age <21 years*
- Currently undergoing or has had recommended treatment of apical or anterior prolapse
- No anterior or apical prolapse > +1 on standing straining prolapse exam
- Pregnant or has not completed child bearing.
- <12 months post-partum*†
- Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage
- History of pelvic radiation therapy
- Previous incontinence surgery
- Current catheter use
- Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
- Previous (i.e. repaired) or current urethral diverticulum
- Prior augmentation cystoplasty or artificial sphincter
- Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
- Any pelvic surgery within the last 3 months*
- Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
- Participation in another treatment intervention trial that might influence results of this trial.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: No UDS
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.
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Office evaluation
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ACTIVE_COMPARATOR: 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.
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Office evaluation
Urodynamics
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.
Time Frame: 12 Months
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Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better" at 12 months.
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12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
Time Frame: Baseline, 12 mos
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The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms.
Scores range from 0 to 300, with higher scores indicating greater distress.
The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.
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Baseline, 12 mos
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Patient Global Impression Index
Time Frame: 12 Months
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Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants, "How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?" Responses are on a 7-point scale from 1 meaning "very much better" to 7 meaning "very much worse."
Values of "very much better" (1) or "much better" (2) were considered to have "perceived improvement" according to this criteria.
Values of 3 or greater were not (e.g.
"a little better", "no change", "a little worse", "much worse" or "very much worse").
This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence.
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12 Months
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Change in Bother as Measured by the UDI
Time Frame: Baseline, 12 Months
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The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms.
Scores range from 0 to 300, with higher scores indicating greater distress.
Change was calculated as the score at 12 months minus the score at baseline.
Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
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Baseline, 12 Months
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Change in Severity as Measured by the ISI
Time Frame: Baseline & 12 Months
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Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity.
Change was calculated as the score at 12 months minus the score at baseline.
Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
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Baseline & 12 Months
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Change in MESA Stress Score
Time Frame: Screen & 12 Months
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The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function.
The outcome measures is change from baseline to 12 mo visit in MESA stress score.
Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100.
Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.
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Screen & 12 Months
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Change in MESA Urge Score
Time Frame: Screen & 12 Months
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The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function.
The outcome measures is change from baseline to 12 mo visit in MESA urge score.
Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100.
Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.
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Screen & 12 Months
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Change in Quality of Life as Measured by the IIQ
Time Frame: Baseline, 12 Months
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Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life.
Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400.
Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
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Baseline, 12 Months
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Change in Quality of Life as Measured by the SF-12
Time Frame: Baseline, 12 Months
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The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health.
Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200.
The larger the positive value, the greater the improvement.
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Baseline, 12 Months
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Change in Severity as Measured by the PGI-S
Time Frame: Baseline & 12 Months
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The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe].
Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
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Baseline & 12 Months
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Moderate or Severe Severity as Measured by the PGI-S
Time Frame: 12 Months
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The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe].
This measure is the percentage of participants responding to the PGI-S with a "3" corresponding to the "moderate" category or a "4" corresponding to the "severe" category at the 12 month visit.
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12 Months
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Patient Satisfaction With Treatment Outcome
Time Frame: 12 Months
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A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.
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12 Months
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Stress Test at 12 Mos
Time Frame: Screen and 12 months
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A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage.
Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test.
The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.
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Screen and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
December 5, 2008
First Submitted That Met QC Criteria
December 5, 2008
First Posted (ESTIMATE)
December 8, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 6, 2013
Last Update Submitted That Met QC Criteria
July 3, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ValUE (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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