Value of Urodynamic Evaluation (ValUE)
Number of Subjects in Study Archive: 630
Study Design: Clinical Trial
Conditions: Urinary Incontinence, Urogenital Diseases
Duration: November 2008 – December 2009
# Recruitment Centers: 11
Treatment: Urodynamic Studies
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00803959
Stress urinary incontinence (SUI) is one of two major subtypes of urinary incontinence, a common and costly condition that significantly impairs quality of life of women of all ages. Surgery is one of the most common treatments for SUI. Urodynamic studies (UDS), which assess physiological variables during bladder storage and emptying, are often performed preoperatively to confirm and characterize the clinical features of the condition or to guide decisions about modifications in treatment. Despite common use of UDS, these studies are uncomfortable and costly, increase the risk of urinary tract infection, and their ability to improve surgical outcomes was unkown.
In response to the lack of evidence concerning the utility of UDS, the Value of Urodynamic Evaluation (ValUE) study, a multi-center noninferiority trial was conducted to compare outcomes among women with SUI who underwent a basic office evaluation without UDS (evaluation-only group) with those among women with SUI who underwent UDS in addition to the office evaluation (urodynamic-testing group) before their planned surgery. Participants with SUI were enrolled from 11 centers nationwide and randomly assigned to a study group. Women in the urodynamic-testing group underwent noninstrumented uroflowmetry with a comfortably full bladder, filling cystometry with Valsalva leak-point pressures, and a pressure-flow study. After interpretation of the urodynamic tests, study physicians again completed the same comprehensive checklist of clinical diagnoses without viewing their previous entries. The primary outcome measure included the Urogential Distress Inventory (UDI), an objective measure that assesses symptoms of incontinence, and the Patient Global Index—Improvement (PGI-I), a patient-reported measure of perceived improvement following treatment. Both measures were assessed at 12 months.
Results showed no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. The study concluded that preoperative office evaluation alone was not inferior to evaluation with UDS on outcomes at one year for women with uncomplicated SUI.
The study aimed to determine whether women with symptomatic, uncomplicated SUI who undergo only a basic office evaluation prior to SUI surgery have non-inferior treatment outcomes compared to women who have the basic office evaluation and UDS. Secondary objectives included determining how often physicians use preoperative UDS results to alter clinical and surgical decision-making, comparing the amount of improvement in incontinence outcomes, and determining the incremental cost and utility of performing UDS as compared to not performing UDS.
The primary outcome measure included: (1) the Urogenital Distress Inventory (UDI), a 20-item patient-reported measure that assesses symptoms of stress incontinence, urge incontinence, urgency, frequency, and voiding dysfunction, and (2) the Patient Global Index – Improvement (PGI-I), a patient-reported measure of perceived improvement after treatment of stress and urge incontinence. Both were assessed at 12 months.
Secondary outcome measures include self-reported stress-type urinary incontinence symptoms, quality of life measures, incontinency severity, preparedness for treatment, and patient satisfaction with treatment outcome. Data on medical and non-medical costs and on how often physicians altered their clinical decision making based on the results of UDS were also collected.
Females of at least 21 years of age who met the following criteria were enrolled:
- Predominant SUI as evidenced by: (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 score)
- Observation of leakage by provocative stress test at any volume
- Eligible for SUI surgery and randomization to either treatment group and desire for non-conservative therapy for SUI
- PVR < 150 ml by any method
- Negative urine dipstick or negative UA or negative culture
- Availability to initiate SUI treatment within 6 weeks of randomization and availability for 12 months of follow-up
Exclusion criteria are documented in the study protocol.
Results showed no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent UDS were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. The study concluded that preoperative office evaluation alone was not inferior to evaluation with UDS on outcomes at 1 year for women with uncomplicated SUI.