Value of Urodynamic Evaluation (NCT00803959) | Clinical Trial Compass
CompletedPhase 4
Value of Urodynamic Evaluation
United States630 participantsStarted 2008-11
Plain-language 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?
Who can participate
Age range21 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Age \<21 years\*
✕. Currently undergoing or has had recommended treatment of apical or anterior prolapse
✕
What they're measuring
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.