Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations (original) (raw)
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Health technology assessment (Winchester, England), 2015
The position of invasive urodynamic testing in the diagnostic pathway for urinary incontinence (UI) is unclear. Systematic reviews have called for further trials evaluating clinical utility, although a preliminary feasibility study was considered appropriate. To inform the decision whether or not to proceed to a definitive randomised trial of invasive urodynamic testing compared with clinical assessment with non-invasive tests, prior to surgery in women with stress UI (SUI) or stress predominant mixed UI (MUI). A mixed-methods study comprising a pragmatic multicentre randomised pilot trial; economic evaluation; survey of clinicians' views about invasive urodynamic testing; qualitative interviews with clinicians and trial participants. Urogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees. Trial recruits were women with SUI or stress predominant MUI who were considering surgery after unsu...
Neurourology and Urodynamics, 2012
Aims: To assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment. Methods: 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. Results: The trial was stopped prematurely because of slow recruitment. We randomly allocated 59 women to a strategy with (N ¼ 31) or without (N ¼ 28) urodynamics. The mean difference in improvement on the UDI-UI was 14 in favor of the group without urodynamics (48 SD AE 22 vs. 34 SD AE 22, 95% CI: À28 to À0.26), 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). Conclusions: 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.
What is the value of urodynamic studies before stress incontinence surgery?
BJOG: An International Journal of Obstetrics & Gynaecology, 2013
Please cite this paper as: Giarenis I, Cardozo L. What is the value of urodynamic studies before stress incontinence surgery ? BJOG 2013;120:130-132. Stress urinary incontinence (SUI) is the most common type of urinary incontinence, and up to 86% of incontinent women report this among their symptoms. SUI is increasingly managed surgically, mainly because of the introduction of minimally invasive operative techniques. Urodynamic studies (UDS) involve the assessment of the function and dysfunction of the urinary tract by any appropriate method. 1 As subjective reporting of symptoms does not always concur with urodynamic findings, UDS have played a central role in the preoperative assessment of SUI sufferers.
2013
for the Dutch Urogynecology Consortium* OBJECTIVE: To estimate whether a strategy of immediate surgery was noninferior to a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI). METHODS: A multicenter diagnostic cohort study with an embedded noninferiority randomized controlled trial was conducted in six academic and 24 nonacademic Dutch hospitals. Women with predominant SUI eligible for surgical treatment based on clinical assessment were included between January 2009 and November 2010. All patients underwent urodynamics. In patients in whom urodynamics were discordant with clinical assessment, participants were randomly allocated to receive either immediate surgery or individually tailored therapy based on urodynamics. The primary outcome was clinical improvement assessed by the Urogenital Distress Inventory 12 months after baseline. Analysis was by intention to treat; a difference in mean improvement of 5 points or less was considered noninferior. RESULTS: Five hundred seventy-eight women with SUI were studied, of whom 268 (46%) had discordant findings. One hundred twenty-six patients gave informed consent for randomization and were allocated to receive immediate surgery (n564) or individually tailored therapy (n562). The mean improvement measured with the Urogenital Distress Inventory after 1 year was 44 points (624) in the group receiving immediate surgery and 39 (625) points in the group receiving individually tailored treatment. The difference in mean improvement was 5 points in favor of the group receiving immediate surgery (95% confidence interval 2N to 5). There were no differences with respect to cure or complication rate. CONCLUSION: In women with uncomplicated SUI, an immediate midurethral sling operation is not inferior to individually tailored treatment based on urodynamic findings.
Journal of Urology, 2013
Purpose-To evaluate the influence of pre-operative urodynamic studies (UDS) on diagnoses, global treatment plan and outcomes in women having surgery for uncomplicated stress predominant urinary incontinence (SUI). Materials & Methods-Secondary analysis from a multicenter, randomized trial of the value of preoperative UDS. Physicians provided pre-and post-UDS diagnoses and global treatment plans, defined as proceeding with surgery, surgery type, surgical modification, non-surgical therapy. Treatment plan changes and surgical outcomes between office evaluation (OE) and OE plus UDS were compared by McNemar's test.
Value of Urodynamics Before Stress Urinary Incontinence Surgery
Obstetrical & Gynecological Survey, 2013
OBJECTIVE: To estimate whether a strategy of immediate surgery was noninferior to a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI).
Neurourology and urodynamics, 2012
AimsTo determine surgeons' views on invasive urodynamic testing (IUT) prior to surgery for stress (SUI) or stress predominant mixed urinary incontinence (MUI).To determine surgeons' views on invasive urodynamic testing (IUT) prior to surgery for stress (SUI) or stress predominant mixed urinary incontinence (MUI).MethodsMembers of British Society of Urogynaecology (BSUG) and British Association of Urological Surgeons Section of Female, Neurological and Urodynamic Urology (BAUS-SFNUU) were sent an email invitation to complete an online “SurveyMonkey®” questionnaire regarding their current use of IUT prior to surgical treatment of SUI, their view about the necessity for IUT in various clinical scenarios, and their willingness to randomize patients into a future trial of IUT. A purposive sample of respondents was invited for telephone interview to explore further how they use IUT to inform clinical decisions, and to contextualize questionnaire responses.Members of British Society of Urogynaecology (BSUG) and British Association of Urological Surgeons Section of Female, Neurological and Urodynamic Urology (BAUS-SFNUU) were sent an email invitation to complete an online “SurveyMonkey®” questionnaire regarding their current use of IUT prior to surgical treatment of SUI, their view about the necessity for IUT in various clinical scenarios, and their willingness to randomize patients into a future trial of IUT. A purposive sample of respondents was invited for telephone interview to explore further how they use IUT to inform clinical decisions, and to contextualize questionnaire responses.ResultsThere were 176/517 (34%) responses, 106/332 (32%) from gynecologists/urogynecologists and 67/185 (36%) from urologists; all respondents had access to IUT, and 89% currently arrange IUT for most women with SUI or stress predominant MUI. For a variety of scenarios with increasingly complex symptoms the level of individual equipoise (“undecided” about IUT) was very low (1–6%) and community equipoise was, at best, 66:34 (IUT “essential” vs. “unnecessary”) even for the simplest scenario. Nevertheless, 70% rated the research question underlying the proposed studies “very important” or “extremely important;” 60% recorded a “willingness to randomize” score ≥8/10.There were 176/517 (34%) responses, 106/332 (32%) from gynecologists/urogynecologists and 67/185 (36%) from urologists; all respondents had access to IUT, and 89% currently arrange IUT for most women with SUI or stress predominant MUI. For a variety of scenarios with increasingly complex symptoms the level of individual equipoise (“undecided” about IUT) was very low (1–6%) and community equipoise was, at best, 66:34 (IUT “essential” vs. “unnecessary”) even for the simplest scenario. Nevertheless, 70% rated the research question underlying the proposed studies “very important” or “extremely important;” 60% recorded a “willingness to randomize” score ≥8/10.ConclusionsMost urogynecologists and urologists consider IUT essential before surgery in SUI with or without other symptoms. Most however recognize the need for further research, and indicated a willingness to recruit into multicenter trials addressing this question. Neurourol. Urodynam. 31:?–?, 2012. © 2012 Wiley Periodicals, Inc.Most urogynecologists and urologists consider IUT essential before surgery in SUI with or without other symptoms. Most however recognize the need for further research, and indicated a willingness to recruit into multicenter trials addressing this question. Neurourol. Urodynam. 31:?–?, 2012. © 2012 Wiley Periodicals, Inc.