Recurrent stress urinary incontinence surgery in the United Kingdom: an analysis of the British Society of Urogynaecology database (2007-2015).

INTRODUCTION AND HYPOTHESIS: There is a lack of robust evidence guiding treatment options for recurrent stress urinary incontinence (SUI) and limited comparative outcome data. The aim of this study was to examine the pattern of surgery for recurrent SUI performed by gynaecologists in the UK and compare subjective success rates. METHODS: Retrospective review of the British Society of Urogynaecologists database for patients having repeat incontinence procedures (2007-2015) including the number of each procedure and outcome recorded by the International Consultation on Incontinence Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire. Procedures were compared by year and outcomes by operation. Categorical comparisons were performed using Chi-squared test and numerical comparisons using appropriate non-parametric tests. RESULTS: A total of 2,938 records were obtained (269 were excluded) and 2,164 women (88.8%) had undergone one previous procedure, most commonly retropubic midurethral sling (MUS; 28.6%). Pelvic floor exercises were offered to 76.2% women. Urodynamic investigation was carried out in 96.2% women: 76.5% had urodynamic stress incontinence. Repeat MUS was the most common procedure (77.3%), followed by bladder neck injections (BNI; 10.2%). Follow-up details were available for 66.1%. Outcome data were poorly reported. Median ICIQ-UI-SF score fell from 16 (0-21) to 0 (0-21) (p < 0.001), 81.6% felt "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I), and 89.3% "cured" or "improved". MUS, colposuspension and fascial sling showed the best results with regard to the PGI-I score and "change in SUI" (p < 0.001). CONCLUSION: MUS and BNI were the most common repeat continence procedures. Follow-up data suggest that MUS, colposuspension and fascial sling are most effective.

Surgeon-Team Separation in Robotic Theaters: A Qualitative Observational and Interview Study.

BACKGROUND: The rapid uptake of robotic surgery has largely been driven by the improved technical aspects of minimally invasive surgery including improved ergonomics, wristed instruments, and 3-dimensional vision. However, little attention has been given to the effect of physical separation of the surgeon from the rest of the operating team. PURPOSE: The aim of this study was to examine in depth how this separation affected team dynamics and staff emotions. METHODS: Robotic procedures were observed in 2 tertiary hospitals, and laparoscopic/open procedures were added for comparison; field notes were taken instantaneously. One-to-one interviews with theater team members were audio recorded and transcribed verbatim. Qualitative analysis was conducted via grounded theory approach using NVIVO11. RESULTS: Twenty-nine participants (26 interviewed) were recruited to the study (11 females) and 134 (109 robotic) hours of observation were completed across gynecology, urology, and colorectal surgery.The following 3 main themes emerged with compounding factors identified: (a) communication challenge, (b) immersion versus distraction, and (c) emotional impact. Compounding factors included the following: individual and team experience, staffing levels, and the physical theater environment. CONCLUSIONS: Our emergent theory is that "surgeon-team separation in robotic theaters poses communication challenges which impacts on situational awareness and staff emotions." These can be ameliorated by staff training, increased experience, and team/procedure consistency.

Interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women.

BACKGROUND: Surgery is a common treatment modality for stress urinary incontinence (SUI), usually offered to women for whom conservative treatments have failed. Midurethral tapes have superseded colposuspension because cure rates are comparable and recovery time is reduced. However, some women will not be cured after midurethral tape surgery. Currently, there is no consensus on how to manage the condition in these women.This is an update of a Cochrane Review first published in 2013. OBJECTIVES: To assess the effects of interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women; and to summarise the principal findings of economic evaluations of these interventions. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 9 November 2018). We also searched the reference lists of relevant articles. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials in women who had recurrent stress urinary incontinence after previous minimally invasive midurethral tape surgery. We included conservative, pharmacological and surgical treatments. DATA COLLECTION AND ANALYSIS: Two review authors checked the abstracts of identified studies to confirm their eligibility. We obtained full-text reports of relevant studies and contacted study authors directly for additional information where necessary. We extracted outcome data onto a standard proforma and processed them according to the guidance in the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: We included one study in this review. This study was later reported in an originally unplanned secondary analysis of 46 women who underwent transobturator tape for recurrent SUI after one or more previous failed operations. We were unable to use the data, as they were not presented according to the nature of the first operation.We excluded 12 studies, five because they were not randomised controlled trials (RCTs) and four because previous incontinence surgery was not performed using midurethral tape. We considered a further three to be ineligible because neither the trial report nor personal communication with the trialists could confirm whether any of the participants had previously undergone surgery with tape.We had also planned to develop a brief economic commentary summarising the principal findings of relevant economic evaluations but supplementary systematic searches did not identify any such studies. AUTHORS' CONCLUSIONS: There were insufficient data to assess the effects of any of the different management strategies for recurrent or persistent stress incontinence after failed midurethral tape surgery. No published papers have reported exclusively on women whose first operation was a midurethral tape. Evidence from further RCTs and economic evaluations is required to address uncertainties about the effects and costs of these treatments.

Geographical variation in rates of surgical treatment for female stress urinary incontinence in England: a national cohort study.

OBJECTIVE: To examine geographic variation in use of surgery for female stress urinary incontinence (SUI), mainly midurethral mesh tape insertions, in the English National Health Service (NHS). DESIGN: National cohort study. SETTING: NHS hospitals. PARTICIPANTS: 27 997 women aged 20 years or older who had a first SUI surgery in an English NHS Hospital between April 2013 and March 2016 and a diagnosis of SUI at the same time as the procedure. METHODS: Multilevel Poisson regression was used to adjust for geographic differences in age, ethnicity, prevalence of long-term illness and socioeconomic deprivation. PRIMARY OUTCOME MEASURE: Rate of surgery for SUI per 100 000 women/year at two geographic levels: Clinical Commissioning Group (CCG; n=209) and Sustainability and Transformation Partnership (STP; n=44). RESULTS: The rate of surgery for SUI was 40 procedures per 100 000 women/year. Risk-adjusted rates ranged from 20 to 106 procedures per 100 000 women/year across CCGs and 24 to 69 procedures per 100 000 women/year across the STP areas. These regional differences were only partially explained by demographic characteristics as adjustment reduced variance of surgery rates by 16% among the CCGs and 35% among the STPs. CONCLUSIONS: Substantial geographic variation exists in the use of surgery for female SUI in the English NHS, suggesting that women in some areas are more likely to be treated compared with women with the same condition in other areas. The variation reflects differences in how national guidelines are being interpreted in the context of the ongoing debate about the safety of SUI surgery.

Acceptability and utilisation of patient-initiated follow-up for endometrial cancer amongst women from diverse ethnic and social backgrounds: A mixed methods study.

INTRODUCTION: A shift in focus towards risk stratification and survivorship in early stage endometrial cancer (EC) has led to the replacement of hospital follow-up (HFU) with patient-initiated follow-up (PIFU) schemes. METHODS: A mixed methods study was undertaken prospectively to investigate utility and patient satisfaction with a newly introduced PIFU scheme. RESULTS: Two hundred and twenty-eight women were enrolled onto PIFU in the first 18 months, median age 65 years (range 42-90 years). Twenty-four (10.5%) women were non-British White ethnicity. Forty-five women contacted the Clinical Nurse Specialist (CNS) at least once (19.7%), the primary reason being vaginal bleeding/discharge (42%). Contact was greater in first six months on the scheme compared to the second 6 months, and women who made contact were significantly younger than those who did not (57 years vs. 65 years, p < 0.001). CONCLUSIONS: PIFU appears to be well received by the majority of women. Although many of the CNS contacts were due to physical symptoms, a number were for psychological support or reassurance. Younger women had greater CNS contact indicating that they may benefit from a greater level support. Patient feedback of the PIFU scheme was positive, with many women reporting that it enabled them to have more control over their own health.

Validation of a water-load protocol to define the pattern of bladder sensation.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to confirm reliability of a water-load diuresis protocol and to assess the utility of bladder sensation curves. METHODS: For confirmation of fixed diuresis rate (phase 1), 12 volunteers consumed 250-300 ml of water every 15 min and recorded bladder sensation on a visual analogue scale (VAS) every 5 min to maximum sensation over two filling cycles: voids 1 and 2 (V1 and V2). The test was performed twice. For test-retest validation (phase 2), 24 participants underwent the same protocol drinking 300 ml of water every 15 min. Diuresis rates and voided volumes were compared between cycles and across tests. RESULTS: In phase 1, there was no difference in median void volume (V1 735 ml, V2 678 ml p = 0.433) or median diuresis rates (V2 12.1 ml/min, V3 14.4 ml/min p = 0.136) between cycles. When comparing those who drank 250-300 ml/15 min, there was less variability in those drinking 300-ml aliquots, so this was standardised for later experiments; 95% upper confidence limit of variability of the diuresis rate was calculated as 4.5 ml/min. Any test with a greater difference was rejected as invalid. In phase 2, only 16 participants were analysed. There was no difference in median void volumes between tests [V1 763 ml and 820 ml (p = 0.109) and V2 788 ml and 796 ml (p = 0.266)] or in diuresis rates between test 1 (12.33 ml/min) and 2 (14.40 ml/min) (p = 0.056). Median area under the curve was similar between test 1 404.96 and test 2 418.63. CONCLUSIONS: This refined protocol reliably produced stable diuresis with a water load of 300 ml/15 min, excluding those with a difference in diuresis rate > 4.5 ml/min.

Methods of assessing and recording bladder sensation: a review of the literature.

INTRODUCTION AND HYPOTHESIS: The objective was to review different methods that have been used to assess bladder sensation and to provide an overview of the accuracy and objectivity of the measurement of the subjective perception of the bladder. METHODS: The MEDLINE and PubMed databases were searched to identify articles. References from those articles were also searched. Terms used for the search were: urinary bladder, sensation, cystometry, urodynamics, urinary incontinence and focus group. Eight hundred and fifty abstracts were identified from databases, and 12 from other sources. Twenty-two duplicate articles were removed. Irrelevant articles were excluded after reading their titles. Fifty-four articles were eligible, but 17 were excluded after reading the full text, leaving 37 articles where assessment of bladder sensation was the main aim. RESULTS: Six different methods of measuring bladder sensation have been described in the literature. Although the most frequently used was cystometry, this is an invasive tool and does not reproduce bladder behaviour during daily life because it records bladder sensation as episodic events. The visual analogue scale using a forced diuresis protocol seemed to be an excellent tool. It was non-invasive and evaluated bladder sensation continuously, from an empty to a full bladder. CONCLUSIONS: In some of the studies, the samples were too small to draw any significant conclusions. There were also conflicting data on which tool was the most accurate, especially as each method of evaluating bladder sensation may influence the way it is described by participants.

Long-term Rate of Mesh Sling Removal Following Midurethral Mesh Sling Insertion Among Women With Stress Urinary Incontinence.

Importance: There is concern about outcomes of midurethral mesh sling insertion for women with stress urinary incontinence. However, there is little evidence on long-term outcomes. Objective: To examine long-term mesh removal and reoperation rates in women who had a midurethral mesh sling insertion for stress urinary incontinence. Design, Setting, and Participants: This population-based retrospective cohort study included 95 057 women aged 18 years or older who had a first-ever midurethral mesh sling insertion for stress urinary incontinence in the National Health Service hospitals in England between April 1, 2006, and December 31, 2015. Women were followed up until April 1, 2016. Exposures: Patient and hospital factors and retropubic or transobturator mesh sling insertions. Main Outcomes and Measures: The primary outcome was the risk of midurethral mesh sling removal (partial or total) and secondary outcomes were reoperation for stress urinary incontinence and any reoperation including mesh removal, calculated with death as competing risk. A multivariable Fine-Gray model was used to calculate subdistribution hazard ratios as estimates of relative risk. Results: The study population consisted of 95 057 women (median age, 51 years; interquartile range, 44-61 years) with first midurethral mesh sling insertion, including 60 194 with retropubic insertion and 34 863 with transobturator insertion. The median follow-up time was 5.5 years (interquartile range, 3.2-7.5 years). The rate of midurethral mesh sling removal was 1.4% (95% CI, 1.3%-1.4%) at 1 year, 2.7% (95% CI, 2.6%-2.8%) at 5 years, and 3.3% (95% CI, 3.2%-3.4%) at 9 years. Risk of removal declined with age. The 9-year removal risk after transobturator insertion (2.7% [95% CI, 2.4%-2.9%]) was lower than the risk after retropubic insertion (3.6% [95% CI, 3.5%-3.8%]; subdistribution hazard ratio, 0.72 [95% CI, 0.62-0.84]). The rate of reoperation for stress urinary incontinence was 1.3% (95% CI, 1.3%-1.4%) at 1 year, 3.5% (95% CI, 3.4%-3.6%) at 5 years, and 4.5% (95% CI, 4.3%-4.7%) at 9 years. The rate of any reoperation, including mesh removal, was 2.6% (95% CI, 2.5%-2.7%) at 1 year, 5.5% (95% CI, 5.4%-5.7%) at 5 years, and 6.9% (95% CI, 6.7%-7.1%) at 9 years. Conclusions and Relevance: Among women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%. These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.

Invasive urodynamic testing prior to surgical treatment for stress urinary incontinence in women: cost-effectiveness and value of information analyses in the context of a mixed methods feasibility study.

BACKGROUND: INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?) was a mixed methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing (IUT) prior to surgery for stress urinary incontinence (SUI) in women. Here we report one of the study's five components, with the specific objectives of (i) exploring the cost-effectiveness of IUT compared with clinical assessment plus non-invasive tests (henceforth described as 'IUT' and 'no IUT' respectively) in women with SUI or stress-predominant mixed urinary incontinence (MUI) prior to surgery, and (ii) determining the expected net gain (ENG) from additional research. METHODS: Study participants were women with SUI or stress-predominant MUI who had failed to respond to conservative treatments recruited from seven UK urogynaecology and female urology units. They were randomised to receive either 'IUT' or 'no IUT' before undergoing further treatment. Data from 218 women were used in the economic analysis. Cost utility, net benefit and value of information (VoI) analyses were performed within a randomised controlled pilot trial. Costs and quality-adjusted life years (QALYs) were estimated over 6 months to determine the incremental cost per QALY of 'IUT' compared to 'no IUT'. Net monetary benefit informed the VoI analysis. The VoI estimated the ENG and optimal sample size for a future definitive trial. RESULTS: At 6 months, the mean difference in total average cost was £138 (p = 0.071) in favour of 'IUT'; there was no difference in QALYs estimated from the SF-12 (difference 0.004; p = 0.425) and EQ-5D-3L (difference - 0.004; p = 0.725); therefore, the probability of IUT being cost-effective remains uncertain. The estimated ENG was positive for further research to address this uncertainty with an optimal sample size of 404 women. CONCLUSIONS: This is the largest economic evaluation of IUT. On average, up to 6 months after treatment, 'IUT' may be cost-saving compared to 'no IUT' because of the reduction in surgery following invasive investigation. However, uncertainty remains over the probability of 'IUT' being considered cost-effective, especially in the longer term. The VoI analysis indicated that further research would be of value. TRIAL REGISTRATION: ISRCTN. ISRCTN71327395. Registered 7 June 2010.

Surgery for recurrent stress urinary incontinence: the views of surgeons and women.

INTRODUCTION AND HYPOTHESIS: The objectives were to explore the views of women with recurrent stress incontinence (SUI) with regard to treatment preferences and the acceptability of randomisation to a future trial, and to survey the views of UK specialists on treatment preferences and equipoise regarding different treatment alternatives. METHODS: An online survey of the British Society of Urogynaecology (BSUG) and British Society of Urological Surgeons (BAUS) was carried out. Qualitative semi-structured interviews with a purposive sample of surgeons and women suffering from recurrent SUI from three UK centres. RESULTS: Two hundred fifty-six survey replies were received (176 gynaecology; 80 urology). Comparing the treatments offered, urogynaecologists were more likely to offer pelvic floor exercises (p < 0.05), and repeat midurethral tape (MUT) (p < 0.001). From the Surgical Equipoise Scale (SES) responses, "no preference" was rarely the commonest response. Marked differences for several options existed; midurethral tape dominated responses whenever it appeared. Twenty-one clinicians were interviewed. Treatment preferences were complex, influenced by a range of factors (reason for failure, patient comorbidity, investigations, personal experience, training). A future trial was regarded as important. Eleven women were interviewed. Most had considered more than one option, but felt that decision-making was more a process of elimination rather than a positive process. Randomisation to a study was regarded as unacceptable by most. CONCLUSIONS: No consensus exists among surgeons about preferred treatment options for recurrent SUI, and personal experience and training dominate decision-making. For patients, choices were usually based on an elimination of options, including that of a repeat failed procedure. This contrasts with surgeons, who mostly preferred a repeat MUT above other options. Any future comparative study will be challenging.

Awareness of HPV infection and attitudes toward HPV vaccination among Latvian adolescents.

OBJECTIVE: To evaluate awareness of HPV and its vaccine among Latvian adolescents. METHODS: A cross-sectional survey was conducted in a 2-week period in September 2015 among 270 adolescents attending a secondary school in Riga, Latvia. All students present during sexual-health classes (grades 10-12 [aged 16-21 years]) were included. A self-administered paper-based survey assessed sociodemographic factors, sexual behaviours, smear history and knowledge of sexually transmitted infections, HPV and HPV vaccine knowledge, and sources of information. RESULTS: Overall, 121 surveys were completed (62 by male students and 59 by female students). Latvian adolescents lacked awareness of HPV: only 26 (21.5%) had heard of HPV (21 [35.6%] female students vs 5 [8.1%] male students; P<0.001) and 12 (9.9%) of the HPV vaccine. Eighty (66.1%) participants felt inadequately informed about HPV. However, the adolescents partook in high-risk behaviours: 70 (57.9%) students were sexually active, 26 (37.1%) of whom had already had three or more sexual partners. CONCLUSION: Despite the high prevalence of HPV in Latvia, poor knowledge about HPV infection among adolescents could explain low uptake of the HPV vaccine by this high-risk population. Therefore, educational strategies that highlight the consequences of HPV could promote acceptance of vaccination.

Patient factors associated with onabotulinum toxin A treatment outcome in women with detrusor overactivity.

OBJECTIVE: To evaluate potential predictors of non-response to treatment with 200U onabotulinum toxin A (onaBoNTA) in women with refractory detrusor overactivity (DO). SUBJECTS AND METHODS: A secondary analysis of a randomized trial of 200U onaBoNTA versus placebo in women with refractory DO analyzed baseline and 6 week follow-up data. Univariate and multivariate logistic regression were used to assess demographic factors and baseline clinical parameters on non-response to treatment defined as 20% or less improvement in urinary urgency and leakage episodes, 10% or less in voiding frequency, not achieving continence, and "no change" or worse on PGI-I score at 6 weeks. RESULTS: One Hundred and twenty-two women were included. Twenty-nine (23.8%), 24 (19.7%), and 19 (15.6%) were non-responders to treatment for urgency, voiding, and leakage episodes, respectively. Fifty-nine (48.4%) failed to achieve continence, and 28 (23%) were non-responders on the PGI-I scale. Smoking status (OR: 2.89 95%CI 1.08, 7.73, P = 0.034) predicted non-response in urgency episodes, and higher baseline leakage episodes (OR: 1.17 95%CI 1.04, 1.31, P = 0.007) predicted non-response in achieving continence. Increasing age (OR 1.04, 95%CI 1.0, 1.09, P = 0.063) and body mass index (BMI) (OR 1.07, 95%CI 1.0, 1.16, P = 0.065) showed marginal associations with non-response on the PGI-I scale. CONCLUSION: onaBoNTA is an effective treatment for refractory DO, but some fail to respond. For identification of women at risk, our data indicate smokers should be advised of a lesser chance of successful treatment. Older women, those with high BMI and with more severe leakage also have a higher risk of failure. Neurourol. Urodynam. 36:426-431, 2017. © 2016 Wiley Periodicals, Inc.

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study.

BACKGROUND: The INVESTIGATE-I study was designed to inform a future definitive randomised trial of invasive urodynamic testing, compared to basic clinical assessment with noninvasive tests prior to surgical treatment, in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. In a pilot randomised controlled trial, women from seven participating sites were screened, consented and randomised. Overall, 771 patients were identified from clinic notes and correspondence as being potential recruits and were sent the Patient Information Leaflet. Of those screened, 284 were deemed eligible, giving an overall 'screen positive' rate of 37 %. The numbers screened at individual centres varied between 14 and 399; the 'screen positive' rate varied between 22 and 79 % and the percentage of eligible women recruited varied between 55 and 100 %. The aim of this additional substudy was to explore why 'screen positive' rates may have varied so widely between apparently similar sites. RESULTS: All 11 trial staff involved in screening in the seven recruiting sites were asked to evaluate a series of 20 identical vignettes, mainly based on actual general practitioner referral letters. Of the vignettes, 16 mentioned one or more definite inclusion criteria; the remainder had possible inclusions. Four had definite exclusions; 12 had possible exclusions. Free-text comments were sought to clarify the screeners' decisions. For six vignettes everyone agreed that the patient was eligible; for one all agreed she was not eligible; the breakdown for the remainder was mixed. Free-text comments illuminated uncertainties that may have led to variability in judging potential eligibility. CONCLUSIONS: Variability in judgements about potential trial eligibility highlights the importance of explicit and objective inclusion and exclusion criteria, and of agreed strategies for making judgements when information is missing. During the development and planning of trials, vignettes might be a valuable tool for training those involved in screening and recruiting patients, for identifying potential problems and ensuring greater consistency in the application of eligibility criteria. TRIAL REGISTRATION: ISTCTN registry: ISRCTN71327395 , registered on 7 June 2010.

Effects of cannabinoid receptor activation by CP55,940 on normal bladder function and irritation-induced bladder overactivity in non-awake anaesthetised rats.

INTRODUCTION AND HYPOTHESIS: This study was designed to evaluate the effects of CP55,940 on normal bladder function in vivo and examine whether it suppresses urinary frequency induced by nociceptive stimuli in the bladder. Cannabinoid receptor (CBR) activity may be involved in the regulation of bladder function. However, the role of CBR subtypes in micturition has yet to be established. CP55,940 is a synthetic analogue of tetrahydrocannabidiol, which is a psychoactive ingredient of the Cannabis plant. METHODS: Cystometry under urethane anaesthesia was performed to evaluate the effect of intravesical delivery of CP55,940 with or without administration of CB1 antagonist AM251 or CB2 antagonist AM630 on bladder function in female rats. The effects of CP55,940 were also examined in rats with urinary irritation induced by intravesical infusion of acetic acid. RESULTS: Infusion of CP55,940 significantly (p < 0.05) increased micturition interval (MI) and bladder capacity (BC) by 52 % and decreased maximal voiding pressure (MP) by 25 %. Pretreatment with AM251 or AM630 before CP55,940 administration prevented CP55,940-induced increases in MI, BC and reduced MP. Acetic acid induced urinary frequency as evidenced by a reduction in MI and was suppressed by CP55,940. CONCLUSIONS: CP55,940 decreases bladder activity and urinary frequency induced by nociceptive stimuli, probably by suppression of bladder afferent activity. Effects of CP55,940 were abolished by both CBR antagonists. This data implicates a role for the endocannabinoid system in bladder mechanoafferent function in rats. In addition, our results show that CP55,940 reverses urinary frequency exemplified in an overactive bladder model, suggesting it could be an effective treatment for patients with lower urinary tract symptoms.

Early postoperative voiding dysfunction after insertion of retropubic midurethral tape.

INTRODUCTION AND HYPOTHESIS: A significant proportion of patients develop voiding dysfunction after midurethral tape (MUT) insertion, which reduces patient satisfaction. The study's purpose was to identify predictive factors of voiding dysfunction after a retropubic MUT procedure. METHODS: This was a retrospective study of 100 patients who underwent only a retropubic MUT procedure between January 2010 and December 2011. Early voiding dysfunction was defined when patients required a Foley catheter within 48 h. Data including demographic information, urogenital symptoms, previous surgery, preoperative uroflowmetry and urodynamic parameters were analysed using SPSS v22. Univariate analysis of all demographic variables was performed; those significant at 10 % were entered into a multivariate logistic regression. RESULTS: Fourteen patients required Foley catheter insertion, with a median age of 58 years (26-83 years), median BMI 28 kg/m(2) (20-48 kg/m2), and median parity 2 (0-4). Univariate analysis revealed peak flow rate <15 ml/s (OR 3.79; 1.07, 13.4; p = 0.046), bladder capacity (p = 0.044), stress incontinence versus mixed or urge incontinence (p = 0.064) and previous surgery (OR 4.39; 1.34, 14.41; p = 0.015) to be associated with voiding dysfunction. Multivariate analysis showed only previous pelvic floor surgery to be independently associated (OR 3.76; 1.14, 12.23, p = 0.029). CONCLUSIONS: Only previous pelvic-floor surgery was found to be a strong predictive factor of voiding dysfunction. The rate of voiding dysfunction was similar to those of published data. Previous studies revealed different predictive factors. A larger cohort is needed to provide a definite answer. Those with previous surgery appear to be those most at risk and pre-surgical counselling for these women could be suggested.

Role of serum biomarkers in the prediction of outcome in women with threatened miscarriage: a systematic review and diagnostic accuracy meta-analysis.

BACKGROUND: Threatened miscarriage affects one in five women and is associated with significant emotional distress. The uncertainty around the prognosis of threatened miscarriage makes it equally challenging to the healthcare professionals. Various biochemical markers have been investigated in the past to predict the outcome of threatened miscarriage; however, the results have been conflicting. Therefore, we have conducted a systematic review and meta-analysis to determine the diagnostic accuracy of biochemical markers in predicting the outcome in women presenting with threatened miscarriage. METHODS: This is a systematic review and meta-analysis of prospective studies that investigated biochemical markers to determine outcomes for women with threatened miscarriage at 5-23 weeks gestational age. Electronic databases were searched up to June 2015 and study quality assessment was performed using QUADAS-2 (Quality Assessment for Diagnostic Accuracy Studies-2: A Revised Tool) for evaluating the diagnostic accuracy studies. Statistical analysis was performed using the Cochrane systematic review software. RESULTS: A total of 19 studies were included in the qualitative data synthesis of which 15 (including 1263 women) were eligible for the meta-analysis. The review highlights the role of biochemical markers serum progesterone, hCG, pregnancy associated plasma protein A, estradiol and cancer antigen 125 (CA 125) in the prediction of outcome in women with threatened miscarriage. Interestingly, serum CA 125 appears to be the most promising marker (n = 648 women in seven studies), whereas serum progesterone and hCG are less useful once fetal viability is established. The summary receiver operating characteristics for CA 125 showed a sensitivity of 90% (95% confidence interval (CI) 83-94%), specificity of 88% (95% CI 79-93%), positive likelihood ratio of 7.86 (95% CI 4.23-14.60) and negative likelihood ratio of 0.10 (95% CI 0.06-0.20). The inverse of negative likelihood ratio was 9.31 (95% CI 5-17.1) indicating that a negative test is likely to identify those who are likely to continue with the pregnancy. Serum estradiol was the next best marker with a sensitivity of 45% (95% CI 6-90%), a specificity of 87% (95% CI 81-92%), a positive likelihood ratio of 3.72 (95% CI 1.01-13.71) and a negative likelihood ratio of 0.62 (95% CI 0.20-1.84). CONCLUSIONS: In women with threatened miscarriage, serum CA 125 has high predictive value in identifying pregnancies that are 'likely to continue', whereas the most commonly used biomarkers of serum hCG and progesterone are not useful in predicting outcome of a pregnancy with a viable fetus. Other markers such as inhibin A and a combination of markers need to be investigated to hopefully improve the prediction of outcome in women with threatened miscarriage.

A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study.

BACKGROUND: The position of invasive urodynamic testing (IUT) in diagnostic pathways for urinary incontinence is unclear, and systematic reviews have called for further trials evaluating clinical utility. The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). METHODS: A mixed methods study comprising a pragmatic multicentre randomised pilot trial, a qualitative face-to face interview study with patients eligible for the trial, an exploratory economic evaluation including value of information study, a survey of clinicians' views about IUT, and qualitative telephone interviews with purposively sampled survey respondents. Only the first and second of these elements are reported here. Trial participants were randomised to either clinical assessment with non-invasive tests (control arm) or clinical assessment with non-invasive tests plus IUT (intervention arm). The main outcome measures of these feasibility studies were confirmation that units can identify and recruit eligible women, acceptability of investigation strategies and data collection tools, and acquisition of outcome data to determine the sample size for a definitive trial. The primary outcome proposed for a definitive trial was ICIQ-FLUTS (total score) 6 months after surgery or the start of nonsurgical treatment. RESULTS: Of 284 eligible women, 222 (78%) were recruited, 165/219 (75%) returned questionnaires at baseline, and 125/200 returned them (63%) at follow-up. Most women underwent surgery; management plans were changed in 19 (19%) participants following IUT. Participants interviewed were positive about the trial and the associated documentation. CONCLUSIONS: All elements of a definitive trial were rehearsed. Such a trial would require between 232 and 922 participants, depending on the target difference in the primary outcome. We identified possible modifications to our protocol for application in a definitive trial including clarity over inclusion/exclusions, screening processes, reduction in secondary outcomes, and modification to patient questionnaire booklets and bladder diaries. A definitive trial of IUT versus clinical assessment prior to surgery for SUI or stress predominant MUI is feasible and remains relevant. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN 71327395, registered 7 June 2010.

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women.

BACKGROUND: 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. OBJECTIVES: 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). DESIGN: 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. SETTING: Urogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees. PARTICIPANTS: Trial recruits were women with SUI or stress predominant MUI who were considering surgery after unsuccessful conservative treatment. Relevant clinicians completed two online surveys. Subsets of survey respondents and trial participants took part in separate qualitative interview studies. INTERVENTIONS: Pilot trial participants were randomised to undergo clinical assessment with non-invasive tests (control arm); or assessment as controls, plus invasive urodynamic testing (intervention arm). MAIN OUTCOME MEASURES: Confirmation that units can identify and recruit eligible women; acceptability of investigation strategies and data collection tools; acquisition of outcome data to determine the sample size for a definitive trial. The proposed primary outcome for the definitive trial was International Consultation on Incontinence Modular Questionnaire (ICIQ) Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (total score) 6 months after surgery or the start of non-surgical treatment; secondary outcomes included: ICIQ-FLUTS (subscales); ICIQ Urinary Incontinence Short Form; ICIQ Lower Urinary Tract Symptoms Quality of Life; Urogenital Distress Inventory; EuroQol-5D; costs, quality-adjusted life-years (QALYs) and incremental cost per QALY, Short Form 12; 3-day bladder diary. RESULTS: Of 284 eligible women, 222 (78%) were recruited; 165/219 (75%) returned questionnaires at baseline and 125/200 (63%) who were sent questionnaires at follow-up. There were few missing data items in returned questionnaires, with individual outcome scales calculable for 81%-94%. Most women underwent surgery; management plans were changed in 19 (19%) participants following invasive urodynamic testing. Participant Costs Questionnaires were returned by 53% 6 months after treatment; complete data to undertake cost-utility analysis were available in 27% (intervention) and 47% (control). While insufficient to recommend changes in practice, the results suggest further research would be valuable. All clinicians responding to the survey had access to invasive urodynamic testing, and most saw it as essential prior to surgery in women with SUI with or without other symptoms; nevertheless, 70% considered the research question underlying INVESTIGATE important and most were willing to randomise patients in a definitive trial. Participants interviewed were positive about the trial and associated documentation; the desire of some women to avoid invasive urodynamic testing contrasted with opinions expressed by clinicians through both survey and interview responses. CONCLUSIONS: All elements of a definitive trial and economic evaluation were rehearsed; several areas for protocol modification were identified. Such a trial would require to 400-900 participants, depending on the difference in primary outcome sought. FUTURE WORK: A definitive trial of invasive urodynamic testing versus clinical assessment prior to surgery for SUI or stress predominant MUI should be undertaken. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71327395. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

New surgical approaches for urinary incontinence in women.

Urinary incontinence (UI) is highly prevalent and common complaint. A large proportion of women with UI can be correctly diagnosed by their symptoms alone. First line of treatment should follow conservative route in a form of pelvic floor muscle training for stress UI and bladder training for the urgency UI. If conservative management is ineffective, medical and surgical treatment is the next considered. For the treatment of over-active bladder and urgency UI, intra-vesical injections of botulinum toxin A, utilising a flexible or rigid cystoscope has become an established treatment. An alternative to the use of onaBoNTA is sacral nerve stimulation (SNS). Vaginal tapes/slings procedures have become treatment of choice for stress UI. Different approaches of introduction of vaginal tape can be used, including retropubic 'bottom-up' (TVT), and transobturator 'inside-out' (TVT-O), or 'outside-in' (TOT). TVT and TVT-O/TOT seem comparable although there are differences in complications (bladder injury with TVT vs. leg pain with TVT-O/TOT). Recently single incision approaches have been introduced whereby the vaginal tape is inserted via a single vaginal incision. Based on current evidence, single incision slings are not recommended. Individual clinicians should decide which to use based on expertise and experience, nevertheless, bladder injuries are probably less of an issue than leg pain.