Back to resultsValue of Urodynamic Evaluation (ValUE)
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Office evaluation
UDS
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Stress urinary incontinence, Mixed, Urge
Eligibility Criteria
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.
Sites / Locations
- University of Alabama
- University of California
- Loyola University Medical Center
- University of Maryland
- Oakwood Hospital/Cancer Center
- Beaumont Hospital
- University of Pittsburgh
- University of Texas Southwestern
- University of Texas Health Sciences Center
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
No UDS
UDS
Arm Description
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation with preoperative urodynamic studies prior to surgery.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
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.
Patient Global Impression Index
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.
Change in Bother as Measured by the UDI
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.
Change in Severity as Measured by the ISI
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.
Change in MESA Stress Score
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.
Change in MESA Urge Score
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.
Change in Quality of Life as Measured by the IIQ
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.
Change in Quality of Life as Measured by the SF-12
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.
Change in Severity as Measured by the PGI-S
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.
Moderate or Severe Severity as Measured by the PGI-S
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.
Patient Satisfaction With Treatment Outcome
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.
Stress Test at 12 Mos
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.
Full Information
NCT ID
NCT00803959
First Posted
December 5, 2008
Last Updated
July 3, 2013
Sponsor
Carelon Research
Collaborators
University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, University of Utah, Beaumont Hospital, Loyola University
1. Study Identification
Unique Protocol Identification Number
NCT00803959
Brief Title
Value of Urodynamic Evaluation
Acronym
ValUE
Official Title
A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
Collaborators
University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, University of Utah, Beaumont Hospital, Loyola University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Stress urinary incontinence, Mixed, Urge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
630 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No UDS
Arm Type
Active Comparator
Arm Description
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.
Arm Title
UDS
Arm Type
Active Comparator
Arm Description
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation with preoperative urodynamic studies prior to surgery.
Intervention Type
Other
Intervention Name(s)
Office evaluation
Intervention Description
Office evaluation
Intervention Type
Other
Intervention Name(s)
UDS
Other Intervention Name(s)
Urodynamics
Intervention Description
Urodynamics
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
Description
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.
Time Frame
Baseline, 12 mos
Title
Patient Global Impression Index
Description
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.
Time Frame
12 Months
Title
Change in Bother as Measured by the UDI
Description
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.
Time Frame
Baseline, 12 Months
Title
Change in Severity as Measured by the ISI
Description
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.
Time Frame
Baseline & 12 Months
Title
Change in MESA Stress Score
Description
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.
Time Frame
Screen & 12 Months
Title
Change in MESA Urge Score
Description
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.
Time Frame
Screen & 12 Months
Title
Change in Quality of Life as Measured by the IIQ
Description
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.
Time Frame
Baseline, 12 Months
Title
Change in Quality of Life as Measured by the SF-12
Description
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.
Time Frame
Baseline, 12 Months
Title
Change in Severity as Measured by the PGI-S
Description
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.
Time Frame
Baseline & 12 Months
Title
Moderate or Severe Severity as Measured by the PGI-S
Description
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.
Time Frame
12 Months
Title
Patient Satisfaction With Treatment Outcome
Description
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.
Time Frame
12 Months
Title
Stress Test at 12 Mos
Description
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.
Time Frame
Screen and 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Gormley, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oakwood Hospital/Cancer Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22551104
Citation
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.
Results Reference
background
PubMed Identifier
19635587
Citation
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.
Results Reference
result
PubMed Identifier
25327775
Citation
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.
Results Reference
derived
Links:
URL
http://www.uitn.net
Description
UITN Public Website
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