A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery

Abstract

BACKGROUND Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, −0.3 percentage points; 95% confidence interval, −7.5 to 6.9), which was consistent with noninferiority. There were 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 urodynamic tests 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. CONCLUSIONS For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.)

Utility of invasive urodynamics before surgery for stress urinary incontinence

“…In the Value of Urodynamic Evaluation study (ValUE) [1], 11 centers participated. Urodynamic SUI was demonstrated in 97 % of patients.…”

“…Surgery was cancelled in a few cases; in other cases, conservative treatment was tried, and in some patients, the surgical approach was modified [1]. Decision making, however, seems to be subjective and individual.…”

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The utility of invasive urodynamic testing in the preoperative evaluation of women with stress urinary incontinence (SUI) has been challenged by two recent randomized controlled trials (RCTs) [1,2] that could not document any gain on outcome of surgery. However, both studies have common methodological issues that make it difficult to draw a general conclusion.

Urodynamics (UDS) is defined by the International Continence Society (ICS) as the study of the function and dysfunction of the urinary tract by any appropriate method [3].

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Uso de estudio urodinámico simple, para diagnóstico de incontinencia urinaria de esfuerzo.

“…En mujeres con IOE, la cirugía es el pilar del tratamiento y ofrece un mejora demostrable de los síntomas y calidad de vida. Sin embargo, es esencial determinar el tipo de incontinencia urinaria que padece cada paciente debido a las complicaciones asociadas a las mallas suburetrales y al potencial agravamiento de los otros tipos de Incontinencia urinaria cuando se asocian a estas cirugías (9)(10)(11). Se asume que las pacientes que pierden orina cuando tosen, estornudan, se rien o practican actividad física tienen IOE.…”

“…Al evaluar la capacidad diagnóstica de la cistometría simple con test de estrés con tos y RPM en comparación con la urodinamia multicanal, se logra una sensibilidad de 82-94% y una especificidad de 90% (19)(20). Además, el estudio VALUE muestra que a los 12 meses posterior al tratamiento quirúrgico, el grupo evaluado con cistometría simple y test de estrés con tos tuvo una tasa de éxito de 77,2%, mientras que el grupo que se evaluó con urodinamia demostró un 76,9% de mejoría (10). Nuestra unidad se formó hacia fines del año 2014 y, desde un comienzo se protocolizó la evaluación de las pacientes con incontinencia urinaria.…”