VALUE: Value of Urodynamic Evaluation Before Stress-Incontinence Surgery
VALUE was an assessor-blinded, multicenter, randomized noninferiority trial in women with uncomplicated, demonstrable stress-predominant urinary incontinence that found office evaluation alone noninferior to office evaluation plus multichannel urodynamics before surgery for 12-month patient-reported treatment success (77.2% versus 76.9%).[1]
- Design and population
- Multicenter randomized noninferiority trial. Women aged 21 years or older with uncomplicated, demonstrable stress-predominant urinary incontinence seeking surgery; positive office stress test, postvoid residual below 150 mL, and no urinary infection.
- Arms
- Office evaluation plus urodynamic testing before planned continence surgery versus office evaluation alone before planned continence surgery
- Report and follow-up
- 2012 · 12 months after treatment
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| 12-month patient-reported composite success; risk difference in percentage points (urodynamics minus office only) | 203/264 (76.9%) vs 200/259 (77.2%) | difference -0.3; CI -7.5–6.9 | Met |
Harms: Any adverse event: 21.3% vs 19.4%
Design
Eligible women were at least 21 years old, had stress symptoms for at least 3 months that exceeded urgency symptoms on the MESA questionnaire, desired surgery, and leaked with cough or Valsalva during an office stress test at any bladder volume. The office evaluation also required assessment of urethral mobility, postvoid residual <150 mL, and a negative urinalysis or culture. Prior incontinence surgery, pelvic irradiation, recent pelvic surgery, and anterior or apical prolapse extending at least 1 cm beyond the hymen were exclusions. Randomization was stratified by surgeon across 11 centers; 38 urogynecologists and 15 urologists operated, and more than 90% were fellowship-trained.[1]
Treatment success required both a reduction of at least 70% in the Urogenital Distress Inventory score and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The primary analysis included women who received their assigned evaluation and supplied 12-month outcome data. The prespecified noninferiority margin was 11 percentage points: the upper confidence limit for the success-rate difference, urodynamics minus office only, had to remain below that margin.[1]
Results
In the per-protocol analysis, success occurred in 203/264 women (76.9%) assigned added urodynamics and 200/259 (77.2%) assigned office evaluation alone. The reported risk difference, urodynamics minus office only, was −0.3 percentage points (95% CI −7.5 to 6.9); its upper limit was below the 11-point margin. Intention-to-treat and missing-data sensitivity analyses were concordant.[1]
The planned surgical subgroup required the patient-reported composite plus a negative stress test at 300 mL. Success was 154/222 (69.4%) after added urodynamics and 161/221 (72.9%) after office evaluation alone (P = 0.42); stress-test data were available for 443 of 586 women who underwent surgery.[1]
In a later within-arm analysis, urodynamics changed at least one clinical diagnosis in 167/294 women (56.8%) with evaluable data. A urodynamics-driven global treatment-plan change was recorded in 41/294 (14%); such changes were not associated with the patient-reported success endpoint (OR 0.96, 95% CI 0.41–2.25; P = 0.92), but were associated with more postoperative treatment for urgency incontinence (OR 3.23, 95% CI 1.46–7.14; P = 0.004).[2]
Surgery and treatment delivery
The added test comprised noninstrumented uroflowmetry, filling cystometry with Valsalva leak-point pressure measurement, and a pressure-flow study. Urethral pressure profilometry and video urodynamics were permitted when routine at the site. Surgery proceeded in 298/315 women assigned urodynamics and 288/315 assigned office evaluation alone. Among operated women, retropubic midurethral slings accounted for 64.7% and 64.6%, respectively, and transobturator midurethral slings for 29.0% and 28.1%; the remaining procedures included mini-slings, traditional slings, urethropexy, and bulking injection.[1]
The treatment-plan analysis found 4/294 planned operations canceled after urodynamics, 16/294 procedures changed, including 13/294 switches between retropubic and transobturator midurethral slings, and 20/294 planned sling-tension adjustments; only 7/20 planned adjustments were performed. These were changes within the urodynamics arm, while the overall distribution of operations was similar between randomized groups.[2]
Adverse events
Any adverse event was reported in 21.3% of women assigned added urodynamics and 19.4% assigned office evaluation alone (P = 0.55). Postoperative voiding dysfunction did not differ significantly between groups.[1]
Limitations
The noninferiority margin was selected by clinical judgment, and 523/630 randomized women contributed to the per-protocol primary outcome. Surgeons and participants knew the testing assignment. The comparison depended on a structured office evaluation that demonstrated leakage before randomization, and the operation was predominantly a midurethral sling.[1]
In conversation
- Parallel to UPSTREAM (2020). Same question in women before stress-incontinence surgery; office evaluation alone was noninferior to adding urodynamics.
Guidelines and approvals
AUA/SUFU’s 2023 female SUI guideline permits omission of urodynamics in an index patient seeking treatment when SUI is clearly demonstrated .[3]
The EAU 2026 guideline advises against routine urodynamics when treating uncomplicated stress urinary incontinence . It recommends testing when findings may change invasive treatment or the diagnosis remains uncertain .[4]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2012-05-02 | Primary 12-month report · primary | — | 12-month patient-reported composite success; risk difference in percentage points (urodynamics minus office only): 203/264 (76.9%) vs 200/259 (77.2%); difference -0.3; CI -7.5–6.9 Met 12-month composite success plus negative standardized 300-mL stress test among surgically treated women with available stress-test data: 154/222 (69.4%) vs 161/221 (72.9%); P 0.42 | Nager CW, Brubaker L, Litman HJ, et al. "A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery." *N Engl J Med.* 2012;366(21):1987-1997. doi:10.1056/NEJMoa1113595 DOI |
| 2012-10-08 | Diagnosis and treatment-plan analysis · secondary | — | Within the urodynamic-testing arm, changed diagnosis after office assessment: 167/294 (56.8%); — Descriptive Within the urodynamic-testing arm, any global plan change: 41/294 (14%); — Descriptive Association of urodynamics-driven plan change with 12-month treatment success; odds ratio: Within-arm observational analysis; the interval includes substantial benefit and harm.; OR 0.96; CI 0.41–2.25; P 0.92 Association of urodynamics-driven plan change with postoperative urgency-incontinence treatment; odds ratio: Within-arm observational association, not a randomized comparison; the endpoint counted treatment at 3 or 12 months.; OR 3.23; CI 1.46–7.14; P 0.004 | Sirls LT, Richter HE, Litman HJ, et al. "The Effect of Urodynamic Testing on Clinical Diagnosis, Treatment Plan and Outcomes in Women Undergoing Stress Urinary Incontinence Surgery." *J Urol.* 2013;189(1):204-209. doi:10.1016/j.juro.2012.09.050 DOI |
References
1. Nager CW, Brubaker L, Litman HJ, et al. "A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery." N Engl J Med. 2012;366(21):1987-1997. doi:10.1056/NEJMoa1113595
2. Sirls LT, Richter HE, Litman HJ, et al. "The Effect of Urodynamic Testing on Clinical Diagnosis, Treatment Plan and Outcomes in Women Undergoing Stress Urinary Incontinence Surgery." J Urol. 2013;189(1):204-209. doi:10.1016/j.juro.2012.09.050
3. Kobashi KC, Vasavada S, Bloschichak A, et al. "Updates to Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2023)." J Urol. 2023;209(6):1091-1098. doi:10.1097/JU.0000000000003435
4. Harding CK, Lapitan MC, Arlandis S, et al. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. Arnhem: EAU Guidelines Office; 2026. Section 3.6.4.