Value of Urodynamic Evaluation (ValUE)

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00803959
First received: December 5, 2008
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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?


Condition Intervention Phase
Urinary Incontinence
Other: Office evaluation
Other: UDS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

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. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 12 mos ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 630
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No UDS
Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.
Other: Office evaluation
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.
Other: Office evaluation
Office evaluation
Other: UDS
Urodynamics
Other Name: Urodynamics

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803959

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California
San Diego, California, United States, 92103
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Oakwood Hospital/Cancer Center
Dearborn, Michigan, United States, 48123
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
New England Research Institutes
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
Investigators
Study Chair: Ann Gormley, MD Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00803959     History of Changes
Other Study ID Numbers: ValUE (completed)
Study First Received: December 5, 2008
Results First Received: May 7, 2013
Last Updated: July 3, 2013
Health Authority: United States: Federal Government

Keywords provided by New England Research Institutes:
Stress urinary incontinence, Mixed, Urge

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014