Value of Urodynamic Evaluation

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.