Clinical trial NCT00803959: Value of Urodynamic Evaluation
Official title: A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence, Mixed, Urge
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of California, San Diego
name: University of Maryland
name: University of Pittsburgh
name: University of Texas Southwestern Medical Center
name: The University of Texas Health Science Center at San Antonio
name: University of Utah
name: Beaumont Hospital
name: Loyola University
First posted: 2008-12-08
Enrollment: 630
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
timeFrame: Baseline, 12 mos
measure: Patient Global Impression Index
timeFrame: 12 Months
measure: Change in Bother as Measured by the UDI
timeFrame: Baseline, 12 Months
measure: Change in Severity as Measured by the ISI
timeFrame: Baseline & 12 Months
measure: Change in MESA Stress Score
timeFrame: Screen & 12 Months
measure: Change in MESA Urge Score
timeFrame: Screen & 12 Months
measure: Change in Quality of Life as Measured by the IIQ
timeFrame: Baseline, 12 Months
measure: Change in Quality of Life as Measured by the SF-12
timeFrame: Baseline, 12 Months
measure: Change in Severity as Measured by the PGI-S
timeFrame: Baseline & 12 Months
measure: Moderate or Severe Severity as Measured by the PGI-S
timeFrame: 12 Months
measure: Patient Satisfaction With Treatment Outcome
timeFrame: 12 Months
measure: Stress Test at 12 Mos
timeFrame: Screen and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University of California
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital/Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ann Gormley, MD
role: STUDY_CHAIR
References:
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.
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.
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.