Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non‐inferiority randomized controlled trial

Abstract

AimsTo assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment.MethodsWe performed a multicenter non‐inferiority randomized controlled trial. Women with SUI were randomly allocated to management based on a workup with or without urodynamics. The primary outcome was clinical reduction of complaints as measured with the Urogenital Distress Inventory urinary incontinence subscale (UDI‐UI) at 12 months after the onset of treatment. A mean difference in improvement of less than 8 was considered non‐inferior. The study was analyzed according to intention‐to‐treat.ResultsThe trial was stopped prematurely because of slow recruitment. We randomly allocated 59 women to a strategy with (N = 31) or without (N = 28) urodynamics. The mean difference in improvement on the UDI‐UI was 14 in favor of the group without urodynamics (48 SD ± 22 vs. 34 SD ± 22, 95% CI: −28 to −0.26), confirming non‐inferiority. Addition of urodynamics did not result in a lower occurrence of de novo overactive bladder complaints compared to a workup without urodynamics (6/31 vs. 1/28; RR 5.4, 95% CI: 0.70–42). In the group allocated to urodynamics, initial surgical management was more often abandoned compared to the group not allocated to urodynamics (5/31 vs. 1/28; RR 4.5, 95% CI: 0.56–36).ConclusionsIn this relatively small study, the omission of urodynamics was not inferior to the use of urodynamics in the preoperative workup of women with SUI. Women with SUI undergoing urodynamics had the risk of a choice for more prudent treatment, which seemed to result in a delay until effective treatment. Neurourol. Urodynam. 31:1118–1123, 2012. © 2012 Wiley Periodicals, Inc.

The role of preoperative urodynamics in stress urinary incontinence surgery

“…The VUSIS and ValUE trials were included in this analysis along with data from a small, European, single-centre study abstract. 4,6,7 There was no statistical difference in the risk ratio (RR) of subjective cure, objective cure, or complications, such as voiding dysfunction or urinary urgency between those with and without preoperative UDS. 8 …”

“…Three of these five patients eventually had SUI surgery and the authors therefore concluded that preoperative UDS has the risk of delaying effective treatment. 4 The Value of Urodynamic Evaluation (ValUE) trial randomized 630 women with uncomplicated, demonstrable SUI to undergo preoperative office evaluation with and without UDS. The primary outcome was treatment success at 12 months, defined as a ≥70% reduction in UDI score and a response of "much better" or "very much better" on the Patient Global Impression of Improvement (PGI-I).…”

Utility of invasive urodynamics before surgery for stress urinary incontinence

“…None of the study centers seem to be UDS-certified by the ICS (or another organization), although there are references to the ICS and the principles of good urodynamic practice [5]. The Dutch study [2] includes one academic and nine nonacademic hospitals. Altogether, 31 patients had invasive UDS (about three per center).…”

“…The Dutch study actually reported aversion against UDS ("...some specialists had already stopped performing urodynamics in this patient category..."), and the study was terminated because of inclusion difficulties [2].…”

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The utility of invasive urodynamic testing in the preoperative evaluation of women with stress urinary incontinence (SUI) has been challenged by two recent randomized controlled trials (RCTs) [1,2] that could not document any gain on outcome of surgery. However, both studies have common methodological issues that make it difficult to draw a general conclusion.

Urodynamics (UDS) is defined by the International Continence Society (ICS) as the study of the function and dysfunction of the urinary tract by any appropriate method [3].

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