Value of Urodynamic Evaluation

NCT00803959 | Completed Phase 4 Results

• 1 other identifier: ValUE (completed)
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 10

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?

Conditions

Urinary Incontinence

Keywords

Stress urinary incontinence, Mixed, Urge

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months

  Baseline, 12 mos

• Patient Global Impression Index

  12 Months

• Change in Bother as Measured by the UDI

  Baseline, 12 Months

• Change in Severity as Measured by the ISI

  Baseline & 12 Months

• Change in MESA Stress Score

  Screen & 12 Months

Study Arms (2)

No UDS

ACTIVE COMPARATOR

Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.

Other: Office evaluation

UDS

ACTIVE COMPARATOR

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; Other: UDS

Interventions

Office evaluation OTHER

Office evaluation

No UDS; UDS

UDS OTHER

Urodynamics

Also known as: Urodynamics

UDS

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carelon Research: lead
• University of Alabama at Birmingham: collaborator
• University of California, San Diego: collaborator
• University of Maryland: collaborator
• University of Pittsburgh: collaborator
• University of Texas Southwestern Medical Center: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• University of Utah: collaborator
• Beaumont Hospital: collaborator
• Loyola University: collaborator

Study Sites (10)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California

San Diego, California, 92103, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Oakwood Hospital/Cancer Center

Dearborn, Michigan, 48123, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229-3900, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

• 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.

  PMID: 22551104 BACKGROUND

• 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.

  PMID: 19635587 RESULT

• 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.

  PMID: 25327775 DERIVED

Related Links

• UITN Public Website

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Heather Litman, PhD
• Organization: New England Research Institutes

hlitman@neriscience.com

617 972 3297

Study Officials

• Ann Gormley, MD

  Dartmouth-Hitchcock Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: August 6, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-07

Locations

US (10)