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Trial record 33 of 34232 for:    value

Value of Urodynamic Evaluation (ValUE)

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ClinicalTrials.gov Identifier: NCT00803959
Recruitment Status : Completed
First Posted : December 8, 2008
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
University of Maryland, College Park
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
Information provided by (Responsible Party):
New England Research Institutes

Tracking Information
First Submitted Date  ICMJE December 5, 2008
First Posted Date  ICMJE December 8, 2008
Results First Submitted Date  ICMJE May 7, 2013
Results First Posted Date  ICMJE August 6, 2013
Last Update Posted Date August 6, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2008)
Self-reported urinary incontinence, irritative and obstructive symptoms. [ Time Frame: 12 Months ]
Change History Complete list of historical versions of study NCT00803959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months [ Time Frame: Baseline, 12 mos ]
    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 [ Time Frame: 12 Months ]
    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 [ Time Frame: Baseline, 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. 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 [ Time Frame: Baseline & 12 Months ]
    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 [ Time Frame: Screen & 12 Months ]
    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 [ Time Frame: Screen & 12 Months ]
    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 [ Time Frame: Baseline, 12 Months ]
    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 [ Time Frame: Baseline, 12 Months ]
    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 [ Time Frame: Baseline & 12 Months ]
    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 [ Time Frame: 12 Months ]
    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 [ Time Frame: 12 Months ]
    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 [ Time Frame: Screen and 12 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2008)
  • MESA [ Time Frame: Screen, 3 & 12 Months ]
  • Quality of Life [ Time Frame: Baseline, 3 Months, 12 Months ]
  • Severity [ Time Frame: Baseline, 3 & 12 Months ]
  • Patient Global Impression Index [ Time Frame: Baseline, 3 Months, 12 Months ]
  • Patient Satisfaction With Treatment Outcome [ Time Frame: 3 and 12 Months ]
  • Voiding Function [ Time Frame: Screen and 12 months ]
  • Stress Test [ Time Frame: Screen and 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Value of Urodynamic Evaluation
Official Title  ICMJE A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
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?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE
  • Other: Office evaluation
    Office evaluation
  • Other: UDS
    Urodynamics
    Other Name: Urodynamics
Study Arms  ICMJE
  • Active Comparator: No UDS
    Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.
    Intervention: Other: Office evaluation
  • 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.
    Interventions:
    • Other: Office evaluation
    • Other: UDS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2010)
630
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2008)
600
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female
  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:

  1. Age <21 years*
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00803959
Other Study ID Numbers  ICMJE ValUE (completed)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New England Research Institutes
Study Sponsor  ICMJE New England Research Institutes
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of Maryland, College Park
  • 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
Investigators  ICMJE
Study Chair: Ann Gormley, MD Dartmouth-Hitchcock Medical Center
PRS Account New England Research Institutes
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP