Value of Urodynamic Evaluation

Completed · Phase 4

Conditions studied: Urinary Incontinence

In brief

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?

Key facts

Study ID

NCT00803959

Run by

Carelon Research

People needed

630

Starts

2008-11-01

Expected to finish

2010-06-01

Last updated by the study team

2013-08-06

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

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
• Participation in another treatment intervention trial that might influence results of this trial.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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