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      Pure stress urinary incontinence: analysis of prevalence, estimation of costs, and financial impact

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          Abstract

          Background

          The prevalence of pure stress urinary incontinence (P-SUI) and the role of urodynamic investigation (UDI) prior to surgery for stress urinary incontinence (SUI) is debated. Since the exact prevalence of P-SUI is not clear, its clinical and economic impact is not well defined. The aims of this study were to evaluate the prevalence of P-SUI in a population of women who underwent UDI for urinary incontinence (UI), also assessing: 1) the correspondence between clinical diagnosis of P-SUI and urodynamic findings; 2) the analysis of costs in terms of UDI and eventually post-UDI avoided surgical procedures.

          Methods

          A single cohort of women who underwent UDI for UI between January 2012 and July 2016 was prospectively collected and retrospectively analyzed. Clinical P-SUI was defined by the strict criteria of the International Continence Society. For each patient, history, physical examination and UDI were collected. The correspondence between clinical and urodynamic findings of P-SUI was analyzed. The rate of clinical P-SUI changed after performing UDI and the number of unnecessary intervention after UDI were reported. A wide cost analysis of UDIs, and the amount of surgical procedures that were believed unnecessary after UDI was reported.

          Results

          Stress urinary incontinence was present in 323/544 (59.4%) patients. The prevalence of clinical P-SUI was 20.7% (67/323), while the prevalence of complicated SUI (C-SUI) was 79.3% (256/323). After UDI, diagnosis of P-SUI decreased to 18.3% (59/232). In 10.2% of cases (6/59) the scheduled middle urethral sling (MUS) was suppressed after the UDI results because 3/6 cases had detrusor overactivity and urge incontinence, in 2/6 cases SUI was treated with a conservative management, in 1/6 case an important voiding dysfunction was detected. Considering the national reimbursement in our country, the cost of each UDI was 296.5 euros and the total amount was 17,493.5 euros. So far the surgery-related savings covered 61.7–105.0% of the costs of total number of UDIs performed in the uncomplicated patients.

          Conclusions

          The prevalence of clinical P-SUI is relevant, involving about 20% of women with clinical SUI. Although the correspondence between clinical and urodynamic diagnosis was high, we demonstrated that UDI may help in some cases to avoid an inappropriate surgical treatment. Therefore, UDI prior to SUI surgery should be considered to achieve a correct diagnosis and a proper therapeutic strategy.

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          Most cited references11

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          A randomized trial of urodynamic testing before stress-incontinence surgery.

          Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).
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            Comparison of diagnostic criteria for female bladder outlet obstruction.

            There is no universally accepted definition of bladder outlet obstruction in women. We compared 5 contemporary urodynamic definitions and determined how well they correlated with each other and with clinical suspicion of bladder outlet obstruction. A total of 154 women who underwent videourodynamics were prospectively evaluated. Clinical obstruction was suspected when history, physical examination, symptoms and basic testing before urodynamics raised the suspicion. Women were classified as having obstruction based on 5 contemporary definitions, including 3 pressure flow cutoff point criteria, videourodynamic criteria and the Blaivas-Groutz nomogram. The McNemar Test was used to compare each definition to the others and to suspicion of clinical obstruction. Of the women 91 were evaluable, including 26 (29%) with obstruction by videourodynamic criteria, 28 (31%) with obstruction by 1998 cut point criteria, 18 (20%) with obstruction by 2000 cut point criteria, 13 (14%) with obstruction by 2004 cut point criteria and 38 (42%) with obstruction by the Blaivas-Groutz nomogram. Videourodynamic and 1998 cut point criteria were not significantly different from each other (78.9% concordance) and each agreed with the clinically obstructed category in the comparison. Compared to the other criteria, the Blaivas-Groutz nomogram overestimated obstruction, while 2004 cut point criteria tended to underestimate it. Each urodynamic definition of female bladder outlet obstruction has merit. Videourodynamic criteria and 1998 cut point criteria have the highest concordance. The Blaivas-Groutz nomogram overestimates obstruction compared to the other criteria. Therefore, it should not be used as the sole or standard definition of obstruction in women.
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              Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial.

              To assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment. We 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. The 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). In 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. Copyright © 2012 Wiley Periodicals, Inc.
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                Author and article information

                Contributors
                emanuele.rubilotta@aovr.veneto.it
                matteo.balzarro@aovr.veneto.it
                antonio.damico@aovr.veneto.it
                mariaangela.cerruto@univr.it
                bassilviamd@gmail.com
                chiara.bovo@aovr.veneto.it
                valerio.iacovelli85@gmail.com
                danielebianchimail@yahoo.it
                walter.artibani@univr.it
                finazzi.agro@med.uniroma2.it
                Journal
                BMC Urol
                BMC Urol
                BMC Urology
                BioMed Central (London )
                1471-2490
                4 June 2019
                4 June 2019
                2019
                : 19
                : 44
                Affiliations
                [1 ]ISNI 0000 0004 1756 948X, GRID grid.411475.2, Department of Urology, , Azienda Ospedaliera Universitaria Integrata (AOUI), ; Piazzale Aristide Stefani, 1, 37126 Verona, Italy
                [2 ]ISNI 0000 0004 1756 948X, GRID grid.411475.2, Healthcare Department Administrator, , Azienda Ospedaliera Universitaria Integrata (AOUI), ; Verona, Italy
                [3 ]ISNI 0000 0001 2300 0941, GRID grid.6530.0, Department of Experimental Medicine and Surgery, Urology Unit, , Tor Vergata University, ; Rome, Italy
                Article
                468
                10.1186/s12894-019-0468-2
                6549321
                31164133
                99cd9d1b-5433-4804-bbc7-6f0a7efa291d
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 13 August 2018
                : 26 April 2019
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Urology
                Urology

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