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.

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Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered AbstractBackground: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting.

This review of clinical studies shows that the level of agreement between classification based on clinical evaluation and based on urodynamic investigation is poor. Urodynamic observations are regarded as gold standard, but based on the poor correlation, this assumption should be questioned.

Introduction and hypothesisThe aim of this study is to assess variations in practice in the use of preoperative urodynamics in women with stress urinary incontinence (SUI).MethodsWe performed an E-survey among all Dutch gynecologists and urologists who have SUI as focus in daily practice. The questions concerned the common policy and preferred policy. Descriptive statistics were used.ResultsOf the 260 targeted specialists, 163 (63%) responded. We found that 37% of the respondents performed standard preoperative urodynamics; in the preferred practice, this would reduce to only 18%. Eighty percent indicated they would operate a patient with a positive stress test without urodynamic SUI, whereas 21% would do this also in case the clinical stress test was negative. Only 9% of the respondents indicated they adapted the choice of the type of sling based on urethral pressure profilometry parameters.ConclusionsUrodynamics are not routinely performed, and outcomes hardly influence the choice of treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s00192-011-1565-2) contains supplementary material, which is available to authorized users.

Introduction Stress urinary incontinence has a negative impact on sexual function. Aim To assess the effect of midurethral sling surgery on sexual activity and function in women with stress urinary incontinence. Methods This is a secondary analysis of the Value of Urodynamics Prior to Stress Incontinence Surgery (VUSIS-II) study, which assessed the value of urodynamics in women with (predominantly) stress urinary incontinence. Patients who underwent retropubic or transobturator sling surgery were included in the present study if information was available on sexual activity before and 12 months after surgery. Data were collected from a self-report validated questionnaire combined with non-validated questions. The association between midurethral sling surgery and sexual function (coital incontinence, satisfaction, and dyspareunia) was compared with McNemar χ2 tests for nominal data and paired t-tests for ordinal data. Potentially influential factors were analyzed with univariable and multivariable logistic regression analyses. Main Outcome Measures Changes in sexual activity and sexual function after midurethral sling surgery. Results Information on sexual activity was available in 293 of the 578 women (51%) included in the VUSIS-II study. At baseline, 252 of 293 patients (86%) were sexually active vs 244 of 293 (83%) after 12 months. More patients with cured stress urinary incontinence were sexually active postoperatively (213 of 247 [86%] vs 31 of 46 [67%], P < .01). There was a significant decrease in coital incontinence (120 of 236 [51%] preoperatively vs 16 of 236 [7%] postoperatively, P < .01). De novo dyspareunia was present in 21 of 238 women (9%). There was a greater improvement in coital incontinence after placement of the retropubic sling compared with the transobturator sling (odds ratio = 2.04, 95% CI = 1.10–3.80, P = .02). Conclusion These data show that midurethral sling surgery has an overall positive influence on sexual function in women with stress urinary incontinence. The retropubic sling is more effective than the transobturator sling for improvement of coital incontinence. De novo dyspareunia was present in 1 of 11 women.

Background Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. Methods The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. Discussion This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. Trial registration Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Introduction and hypothesis The objective was to review the long-term prevalence of pelvic organ prolapse (POP) after laparoscopic hysterectomy (LH) compared with vaginal hysterectomy (VH). Methods An observational cohort study was conducted amongst women who underwent an LH or a VH for benign indications during the period 1996–2004: the POP-UP study. The prevalence of POP was inventoried by a questionnaire involving the Pelvic Floor Distress Inventory (PFDI-20) and a pelvic floor examination (POP-Q). Women were divided into groups based on route and indication of hysterectomy: LH, VH-1 (for nonprolapse), and VH-2 (prolapse). Results Four hundred and six of the 706 eligible patients (58%) returned the questionnaire and 247 underwent POP-Q examination. Sixty-eight patients (17%) received treatment for prolapse; 8% LH, 10% VH-1, and 29% VH-2 (Chi-squared test, p < 0.001). The prevalence of vaginal vault prolapse (apical surgery or ≥ stage 2 at POP-Q) was 4.4% for LH and 5.8% for VH-1 (p = 0.707); and 23% for VH-2 (VH-2 versus others, p < 0.0001). The prevalence of prolapse ≥ stage 2 in any compartment was 62% (n = 153) in total and in 42% of the LH group, 51% of the VH-1 group, and 84% of the VH-2 group (Chi-squared test, p < 0.001). A symptomatic POP (anatomical POP ≥ stage 2 with bulging) was present in 11% of the population. Conclusions No difference was found in the prevalence of POP between LH and VH for nonprolapse indications. However, POP after VH for prolapse occurs more frequently than after hysterectomy for other indications.