Preoperative urodynamic testing in women undergoing surgery for uncomplicated, stress-predominant urinary incontinence commonly results in a change in clinical diagnosis.
Beijing-Preoperative urodynamic testing in women undergoing surgery for uncomplicated, stress-predominant urinary incontinence commonly results in a change in clinical diagnosis. However, the findings of urodynamic testing less often lead to a change in surgical plan, and when it does, it appears not to influence patient-reported outcomes, according to a recent study.
The findings of a planned secondary analysis of data collected in the Value of Urodynamic Evaluation (ValUE) trial were
published in the Journal of Urology (2013; 189:204-9) and presented by first author Larry T. Sirls, MD, at the 2012 International Continence Society annual meeting in Beijing. The authors focused on the cohort of women in the ValUE trial who were randomized to undergo urodynamic testing in addition to a standard office evaluation. Women in the comparator arm in the multicenter ValUE trial were assessed preoperatively by office evaluation only. Half of the 630 women eligible for randomization in ValUE were randomized to urodynamic testing, of whom 307 completed the studies, and 294 had complete data on diagnosis and treatment plan.
More than 50% of diagnoses changed
The findings of urodynamic testing led physicians to change their diagnosis for 57% of the 294 women who underwent the additional evaluation. However, urodynamics infrequently influenced the surgeon to change the global treatment plan (14%) or influenced physicians to cancel (1.4%), change (5.4%), or modify (6.8%) the planned surgery. Importantly, there were no differences in patient outcomes in either the primary efficacy analysis comparing the women who had additional evaluation with urodynamic testing and those who had office evaluation only or in the secondary analysis of the urodynamic testing subgroup, comparing women who had a change in surgical plan versus those who did not.
“The findings of this planned secondary analysis support the ValUE trial’s main conclusion that urodynamic testing is not needed prior to surgery in this select group of patients with uncomplicated, stress-predominant urinary incontinence who are seeking surgery,” said Dr. Sirls, professor of urology and director of female pelvic medicine and reconstructive surgery at William Beaumont School of Medicine, Royal Oak, MI.
“These findings have relevance for a large segment of women seen in daily practice, as the study population was comprised of women with stress-predominant, but mixed urinary incontinence and not just women with pure stress incontinence. However, these data are not an indictment of all urodynamic testing, which can still have an important role in the evaluation of other patients with urinary incontinence and voiding dysfunction.”
Dr. Sirls observed that urodynamic testing is the standard of care internationally for many surgeons planning surgery for stress urinary incontinence despite lack of evidence to establish its value in altering surgical plans or patient outcomes. The ValUE study was designed after further analyses of urodynamic data collected in the SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial Of Mid-Urethral Slings) suggested that there was little to no correlation between the urodynamic testing and patient outcomes.
“The ValUE trial was designed specifically to evaluate the effect of urodynamic testing on surgical outcomes, recognizing that eliminating urodynamic testing could save money and reduce morbidity,” Dr. Sirls explained.
In ValUE, urodynamic findings significantly decreased the number of women diagnosed with overactive bladder-wet, overactive bladder-dry, and suspected intrinsic sphincter deficiency, but significantly increased the number diagnosed with voiding phase dysfunction. Among the 41 patients who had a change in treatment plan based on urodynamic testing, information was available from the physician on what urodynamic test influenced their treatment plan in 29 women, and concern for voiding dysfunction was the most common factor cited. However, there was no difference in postoperative obstructive voiding or surgical outcomes for patients who had a change or modification of the planned surgery based on this finding.
Several of Dr. Sirls’ co-authors have a financial or other relationship with Ethicon and/or Johnson & Johnson.UT