For women with uncomplicated, stress-predominant incontinence, urodynamic testing adds considerable expense without improving surgical outcomes, a recent trial shows.
Beijing-For women with uncomplicated, stress-predominant incontinence, urodynamic testing adds considerable expense without improving surgical outcomes, a recent analysis of the ValUE (Value of Urodynamic Evaluation) trial shows.
Previously published results of the ValUE trial established that for women with uncomplicated, demonstrable stress urinary incontinence (SUI), the addition of urodynamic testing to a thorough preoperative office assessment has no benefit for improving patient outcomes (N Engl J Med 2012; 366:1987-97). Data presented at the 2012 International Continence Society annual meeting in Beijing highlight the significant cost associated with urodynamics.
The cost analyses were undertaken as a planned secondary analysis in the multicenter ValUE trial that randomized 630 women to undergo surgery after having a standard preoperative basic office evaluation only or with urodynamic testing. Women were eligible for randomization if they had stress-predominant UI with objective evidence of leakage on a provocative stress test and no complicating factors (eg, large residual urinary volume, urinary tract infection, neurologic disease, prolapse >stage 2) identified in the office evaluation. There were no differences in surgical outcomes or overall patient satisfaction between the two study groups at 1 year.
The cost analyses presented by first author Peggy A. Norton, MD, considered only the cost of urodynamic testing. Assuming the minimum testing with only complex cystometrogram and complex uroflow, the total cost for the testing of a patient with Medicare coverage, depending on study site, ranged from $350 to $375. Cost of the minimum urodynamic testing paid for by private insurance ranged from $600 to $1,000.
Testing could add millions in costs
To put these data into a real-world perspective, total annual costs to the health care system associated with unnecessary urodynamic testing were calculated based on an estimated 130,000 women in the U.S. having a primary surgical procedure for uncomplicated stress-predominant UI each year and assuming different proportions of patients would undergo the additional testing. At the very least, in a scenario where only 10% of women would have urodynamic testing and all were covered by Medicare, the total cost of the testing was $4.6 million. At the other end of the spectrum, assuming that 90% of women would undergo urodynamic testing and all had private insurance, the testing added over $100 million in costs.
“Urodynamic investigation before SUI surgery has become standard throughout much of the world despite insufficient evidence to support its use. However, for any testing, unless it makes a difference for patient outcomes, it is a luxury, not a necessity,” said Dr. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah, Salt Lake City.
“The findings of the ValUE study indicate surgeons can feel confident skipping this testing for women with uncomplicated, stress-predominant UI undergoing their first surgery because it won’t improve outcomes, and in omitting this testing, they will be saving financial resources that might be better spent elsewhere.”
Now, additional analyses are being conducted looking carefully at incremental costs incurred in the two study groups over the first year after surgery.
“However, we don’t expect to find that the cost effectiveness of urodynamic testing changes one way or the other because there were no differences in adverse events or complications between the study groups,” Dr. Norton said.
Dr. Norton noted that the findings are very practical and applicable to most urologists and gynecologists because the study participants-women with uncomplicated, stress-predominant UI undergoing their first surgery-represent the typical patient seen in their daily practice. However, she cautioned that the results should not be extrapolated to other types of patients.
“The findings do not take away from the fact that urodynamic testing may be very valuable in the setting of complicated incontinence and voiding dysfunction or for women undergoing repeat surgery,” she said.UT