Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial

Abstract

The value of urodynamics (UDS) in the preoperative workup of women with complaints of stress urinary incontinence (SUI) is in question. A previous underpowered randomized controlled trial (RCT) by the same group compared a strategy of UDS and a strategy of immediate surgery in the preoperative workup of women with SUI. Those data showed no benefit of UDS in these women. This multicenter cohort study was designed to determine whether a strategy of immediate surgery is noninferior to a strategy based on urodynamic findings followed by individually tailored therapy in women with SUI. The study was conducted at 6 academic and 24 nonacademic hospitals in the Netherlands between January 2009 and November 2010. All participants enrolled in the study had predominant SUI and were candidates for surgical treatment based on clinical assessment. All subjects underwent UDS according to International Continence Society standards. The primary study outcome was clinical improvement as measured with the Urogenital Distress Inventory (UDI) at 1 year after baseline. A difference in mean improvement of 5 points or less in the UDI urinary incontinence subscale score was considered noninferior. Among 578 women included in the intention-to-treat analysis, 268 (46%) had urodynamic findings discordant with clinical history and physical examination. Study subjects with discordant UDS who consented to take part in a nested randomized trial received either immediate surgery (n = 64) or individually tailored therapy based on UDS (n = 62). After 1 year, the mean improvement measured on the UDI was 44 points (±24) in the group receiving immediate surgery and 39 (±25) points in the group receiving individually tailored treatment. The 5-point difference in mean improvement in the group receiving immediate surgery confirms noninferiority for either 1 of both treatment strategies. The mean improvement of the randomized subjects was also not different from those of the cohort of women for whom UDS was concordant with their clinical diagnosis of SUI. There were no differences between all groups with respect to subjective or objective cure or in the complication rate. These findings show that an immediate midurethral sling operation in women with uncomplicated SUI is not inferior to individually tailored treatment based on urodynamic findings. The data suggest that UDS can be omitted before stress incontinence surgery in women with uncomplicated SUI.