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 range
21 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.