Published in 2012, the ValUE Trial was a multi-center, randomized non-inferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare the outcomes after preoperative office evaluation and urodynamic tests or evaluation or only. This trial concluded that for women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing (UDS) for outcomes at 1 year [1]. Additionally, secondary analysis of the ValUE trial showed that 13-33 million dollars could be saved annually by not performing preoperative UDS [2]. 

The purpose of our investigation is to determine the trends and geographic patterns of pre-operative UDS testing in the United States for female Medicare beneficiaries with a diagnosis of stress urinary incontinence in 2011 and in 2013, before and after the publication of the ValUE trial.

Using The Atlas Rate Generator exploring a 100% Medicare claims data, we identified females with a diagnosis of SUI by ICD-9 code (625.6) and a CPT code for either urethral bulking (51715) or urethral sling procedure (57288), within 306 hospital referral regions (HRR). We then identified the proportion of those who also had a CPT code for UDS within one year prior to their SUI procedure. See Figure 1 for the complete list of included CPT codes for UDS. 

We collected data for 2011 and 2013, before and after the publication of the ValUE trial.

Complete 2011 and 2013 data was available for 151 of the 306 HHRs. Figure 2 displays the results for 2011 and 2013. The national percentage of pre-operative UDS evaluation was 53% (16020/30131) in 2011, compared to 55% (11,772/21579) in 2013, after the publication of the ValUE trial (p=0.157). In 2011, the highest percentage of UDS testing in was performed in Monroe, LA at 81% (48/59) and the lowest in Jonesboro, AR at 22% (14/64). 

In 2013, following the publication of the ValUE trial, the highest percentage of UDS testing was performed in Longview, TX at 88% (43/49) and the lowest in Springfield, MO at 22% (22/99). Only 40% (61/151) of HHRs decreased their use of UDS, while 52% (79/151) increased UDS rates, and 8% (11/151) HHRs stayed the same.

There is significant regional variation in utilization of UDS in those undergoing a SUI procedure. Nationally, the overall rates of UDS, diagnostic testing did not increase or decrease significantly from 2011 to 2013. When evaluating at the HRR level, a larger proportion of HRRs demonstrated increased or unchanged rates after the publication of the ValUE trial results. Our results contrast those found in a prior smaller study of 387 patients at a single institution, where following the publication of the ValUE trial results, the percentage of patients undergoing pre-operative UDS testing dropped to 41% from 70% [3]. 

It should be noted that we were unable to differentiate between UDS testing and surgery performed by urologists versus urogynecologists. In addition, we were unable to account for which patients would be considered complex and thus warrant UDS prior to an incontinence procedure. However, we presumed there would be a similar proportion of patients considered complex in 2011 and 2013. 

The strengths of our study include the fact that 100% of Medicare female beneficiaries were included. Limitations of our study include the fact that The Atlas Rate Generator is only able to provide information of Medicare claims data, thus our conclusion will be unable to generalize to younger patients. In addition, we would be unable to account for coding errors with the claims data.

Following the publication of the ValUE trial, there was no significant change in pre-operative UDS testing for Medicare beneficiaries prior to female incontinence procedure. Further research is needed to investigate the differences in pre-operative UDS testing after the publication of the of the AUA/SUFU SUI guidelines, as well the rates of UDS testing in populations other than Medicare beneficiaries.

Nager CW, Brubaker L, Litman H. A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery. N Engl J Med 2012; 366:1987-1997. DOI: 10.1056/NEJMoa1113595
Norton P, Nager CW, Brubaker L. The Cost of Preoperative Urodynamics: a secondar Analysis of the ValUE Trial. Neurourol Urodyn. 2016 January; 35(1):81-84. DOI:10.1002/nau.22684:
Llody JC, Dielubanza E, Goldman, HB. Trends in urodynamic testing prior to midurethral sling placement - What was the value of the VALUE trial? Neurourology and Urodynamics. 2017;1-7