Value of Urodynamic Evaluation

Urinary Incontinence Clinical Trial

— ValUE  

Official title:

A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803959
• Other study ID #: ValUE (completed)
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2008
• Last updated: July 3, 2013
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2013
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Other:
• Office evaluation
Office evaluation
• UDS
Urodynamics

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Texas Southwestern	Dallas	Texas
United States	Oakwood Hospital/Cancer Center	Dearborn	Michigan
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Beaumont Hospital	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	University of California	San Diego	California

Sponsors (10)

Lead Sponsor	Collaborator
New England Research Institutes	Beaumont Hospital, Loyola University, The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas Southwestern Medical Center, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (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 Eval — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Months	No
Secondary	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.	Baseline, 12 mos	No
Secondary	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.	12 Months	No
Secondary	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.	Baseline, 12 Months	No
Secondary	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.	Baseline & 12 Months	No
Secondary	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.	Screen & 12 Months	No
Secondary	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.	Screen & 12 Months	No
Secondary	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.	Baseline, 12 Months	No
Secondary	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.	Baseline, 12 Months	No
Secondary	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.	Baseline & 12 Months	No
Secondary	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.	12 Months	No
Secondary	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.	12 Months	No
Secondary	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.	Screen and 12 months	No