New England Journal of Medicine · 2012
ValUE
Value of Urodynamic Evaluation

A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery

Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, et al. · Urinary Incontinence Treatment Network
DOI: 10.1056/NEJMoa1113595 · NCT00803959
Design
Noninferiority RCT
Patients
630
Sites
11 US centers
Follow-up
12 months
Per-protocol
~84%
Randomized Arms
Arm A · n = 315
Office Eval + Urodynamics
Standardized office evaluation plus noninstrumented uroflowmetry, filling cystometry, Valsalva leak-point pressures, pressure-flow study
Arm B · n = 315
Office Evaluation Only
Standardized office evaluation alone (stress test, post-void residual, urinalysis)
Primary Outcome: Treatment Success at 12 Months
Noninferiority Comparison (margin: 11%)
NONINFERIOR
76.9%
Urodynamics
203 / 264
vs
77.2%
Eval Only
200 / 259
0
−11% margin
Favors Urodynamics Favors Eval Only
Difference: −0.3%  (95% CI −7.5 to 6.9)
Secondary Outcomes
PGI-I "Much / Very Much Better"
UDS
91.9%
Eval
90.8%
P = 0.68
Positive Stress Test at 12 Months
UDS
16.0%
Eval
11.7%
P = 0.19
Patient Satisfaction (0–100 scale)
UDS
79.5
Eval
82.2
P = 0.28
Key Findings
Diagnostic changes did not alter outcomes. Urodynamics changed clinical diagnoses — fewer diagnosed with OAB with incontinence (25.2% vs 41.6% post-office eval, P<0.001) and more with voiding dysfunction (11.9% vs 2.2%, P<0.001). But these diagnostic changes did NOT alter surgical management or outcomes. ~93% of women in both groups received midurethral slings.
Stress incontinence confirmation: 97% of women in the urodynamics group had stress incontinence confirmed. Surgery cancellation: 5.4% (urodynamics) vs 8.6% (eval only), P = 0.12.
Clinical Bottom Line

For women with uncomplicated, stress-predominant urinary incontinence confirmed by office evaluation with a positive stress test, routine preoperative urodynamics does not improve surgical outcomes at 1 year. A basic office evaluation is sufficient before midurethral sling surgery.