Economic evaluation of surgical treatments for women with stress urinary incontinence: a cost-utility and value of information analysis.

OBJECTIVES: Stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) are common conditions that can have a negative impact on the quality of life of patients and serious cost implications for healthcare providers. The objective of this study was to assess the cost-effectiveness of nine different surgical interventions for treatment of SUI and stress-predominant MUI from a National Health Service and personal social services perspective in the UK. METHODS: A Markov microsimulation model was developed to compare the costs and effectiveness of nine surgical interventions. The model was informed by undertaking a systematic review of clinical effectiveness and network meta-analysis. The main clinical parameters in the model were the cure and incidence rates of complications after different interventions. The outcomes from the model were expressed in terms of cost per quality-adjusted life-years (QALYs) gained. In addition, expected value of perfect information (EVPI) analyses were conducted to quantify the main uncertainties facing decision-makers. RESULTS: The base-case results suggest that retropubic mid-urethral sling (retro-MUS) is the most cost-effective surgical intervention over a 10-year and lifetime time horizon. The probabilistic results show that retro-MUS and traditional sling are the interventions with the highest probability of being cost-effective across all willingness-to-pay thresholds over a lifetime time horizon. The value of information analysis results suggest that the largest value appears to be in removing uncertainty around the incidence rates of complications, the relative treatment effectiveness and health utility values. CONCLUSIONS: Although retro-MUS appears, at this stage, to be a cost-effective intervention, research is needed on possible long-term complications of all surgical treatments to provide reassurance of safety, or earlier warning of unanticipated adverse effects. The value of information analysis supports the need, as a first step, for further research to improve our knowledge of the actual incidence of complications.

Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis.

Background: Stress urinary incontinence (SUI) is a debilitating and highly prevalent condition in the UK. The condition is associated with a significant economic burden for affected patients and society. Current treatment options for SUI include minimally invasive therapies, medication and surgical intervention for the most serious cases. Electrical Muscle Stimulator with Multipath technology is a recently developed device for the treatment of SUI that relies on neuromuscular external electrical stimulation (NEES) technology. The clinical efficacy of the device has been proven in previous studies, but existing evidence surrounding its economic viability is limited.Objectives: To assess the cost-utility of the Electrical Muscle Stimulator with Multipath technology Therapy device for the treatment of SUI amongst women in a UK setting.Methods: An economic model was developed to consider the cost-utility (cost per quality-adjusted life-year [QALY] gained) of Electrical Muscle Stimulator with Multipath technology compared with current practice. A Markov model was developed, with costs and health effects estimated over the lifetime of the patient in the base-case analysis. The model was developed to reflect the treatment pathways typically followed by patients with SUI in the UK. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses.Results: Base-case results indicate that Electrical Muscle Stimulator with Multipath technology results in cost savings and QALY gains over the patient's lifetime. In the "cure" analysis, the intervention is £250 less costly and leads to a 0.03 QALY gain per patient, while in the "improvement analysis", the intervention is £327 less costly and leads to a 0.13 QALY gain per patient. Results from the probabilistic sensitivity analyses show that the likelihood of Electrical Muscle Stimulator with Multipath technology being cost-effective is greater than 74% across all willingness-to-pay thresholds in the two analyses presented.Conclusions: Electrical Muscle Stimulator with Multipath technology is a potentially cost-effective treatment option for patients with SUI who have failed first-line treatment. It could reduce costs to the health care service and improve quality-of-life for selected patients over their lifetime.

Surgical treatments for women with stress urinary incontinence: a systematic review of economic evidence.

BACKGROUND: Surgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women. METHODS: The following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity. RESULTS: Twenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options. CONCLUSIONS: The review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines. SYSTEMATIC REVIEW REGISTRATION: Registered in PROSPERO in 2016, CRD42016049339.

Variation in surgical treatment advice for women with stress urinary incontinence: a study using clinical case vignettes.

INTRODUCTION: The aim of this study was to determine how recommendations of gynaecologists on surgical treatment for stress urinary incontinence (SUI) were influenced by patient characteristics. METHODS: Two hundred forty-five gynaecologists in the UK fully responded to an online questionnaire including 18 vignettes describing 7 clinical characteristics of women with SUI (age, body mass index, SUI type, previous SUI surgery, frequency of leakage, bother, physical status). The gynaecologists scored recommendations for surgery ranging from 1 'certainly not' to 5 'certainly yes'. Mean scores were used to calculate the relative impact ('weight') of each clinical characteristic. Latent class analysis was used to distinguish groups of gynaecologists with a particular practice style because they responded to the patient characteristics captured in the case vignettes in a similar way. RESULTS: The gynaecologists' overall average recommendation score was 2.9 (interquartile range 2 to 4). All patient characteristics significantly influenced the recommendation scores (p always < 0.001) but their impact was relatively small. SUI type was most important (weight 23%), followed by previous SUI surgery (weight 21%). Latent class analysis identified five groups of gynaecologists with practice styles that differed mainly with respect to their mean recommendation score, ranging from 1.3 to 4.0. CONCLUSIONS: Surgical treatment advice in response to case vignettes was only minimally influenced by patient characteristics. There were five groups of gynaecologists whose inclination to recommend surgical treatment varied. This suggests that there is lack of consensus on the role of surgery as a treatment for SUI. A considerable number of gynaecologists were reluctant to recommend surgery.

Risk factors for perineal trauma in the primiparous population during non-operative vaginal delivery.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) are more common in the primiparous population, especially during operative vaginal delivery (OVD). It would therefore be interesting to establish what factors influence the risk of OASIS when adjusting for the risk bias of OVD. METHODS: Retrospective analysis of prospectively collected data from the maternity database at University of Southampton NHS Foundation Trust of primiparous women sustaining OASIS during a singleton, term, cephalic, non-operative vaginal delivery between 2004 and 2015. A control comparison was made of women with otherwise identical birthing conditions but resulting with intact perinea, delivering between 2014 and 2015. Univariate and multivariate logistic regression compared maternal, intrapartum and neonatal factors of those sustaining OASIS with those with an intact perineum. RESULTS: Seven hundred fifty-six women sustaining an OASI met the criteria, and comparisons were made with a control population of 212. Those sustaining an OASI were significantly older (p < 0.001), more likely to be Asian (4.6-fold, p < 0.001) and had heavier babies, with a 3.6-fold greater proportion over 4 kg (p = 0.001). They were more likely to have delivered post-term and had longer second stages of labour (both p < 0.001). Epidural anaesthesia was associated with a 67% reduction in OASIS. CONCLUSIONS: These findings support previous research regarding risk factors for OASIS. By controlling for bias of risk associated with operative vaginal delivery, this revealed a potential protective effect of the use of regional anaesthesia.

Maternal outcomes in subsequent delivery after previous obstetric anal sphincter injury (OASI): a multi-centre retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Women with a history of obstetric anal sphincter injury (OASI) are at increased risk of recurrence (rOASI) at subsequent delivery; however, evidence regarding the factors influencing this risk is limited. Furthermore, little is known about what factors influence the decision to alternatively deliver by elective caesarean section (ELLSCS). METHODS: Retrospective univariate and multivariate logistic regression analysis of prospectively collected data from four NHS electronic maternity databases including primiparous women sustaining OASIS during a singleton, term, cephalic, vaginal delivery between 2004 and 2015, who had a subsequent delivery. RESULTS: Two thousand two hundred seventy-two women met the criteria; 10.2% delivering vaginally had a repeat OASI and 59.4% had a second-degree tear. Women having an ELLSCS were more likely to be Caucasian, older, have previously had an operative vaginal delivery (OVD) and have a more severe degree of OASI. Positive predictors for rOASI were increased birth weight and maternal age at both index and subsequent deliveries, a more severe degree of initial OASI and Asian ethnicity. The overall mediolateral episiotomy (MLE) rate was 15.6%; 77.2% of those who had an episiotomy sustained no spontaneous perineal trauma. Only 4.4% of women with a rOASI had an MLE, whilst the MLE rate was 16.9% in those without a recurrence (p < 0.001). MLE decreased the risk of rOASI by 80%. Birth weight > 4 kg increased the risk 2.5 fold. CONCLUSIONS: Women with previous OASIS are at an increased risk of recurrence. A more liberal use of MLE during subsequent vaginal delivery could significantly reduce the risk of recurrence.

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.

Risk factors for obstetric anal sphincter injuries at vaginal birth after caesarean: a retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Vaginal birth after caesarean (VBAC) is associated with an increased risk of obstetric anal sphincter injuries (OASIS). However, specific factors that influence the risk of OASIS at VBAC have not been studied, particularly whether there are specific baseline characteristics of the first delivery which affect the subsequent perineal outcomes. METHODS: Retrospective analysis of prospectively collected data from University of Southampton NHS Foundation Trusts' maternity database. This included secundiparous women with a previous caesarean delivery (CS) who achieved a singleton, term, cephalic vaginal delivery from 2004 to 2014. Univariate analysis compared maternal, intrapartum and neonatal factors of those who suffered OASIS at VBAC with those who did not. A binary logistic regression model calculated the adjusted, independent odds ratio (OR) of OASIS. RESULTS: A total of 1375 women met the inclusion criteria. The OASIS rate was 8.1%, a 1.4-fold increase compared with primiparous women [difference 2.4% (95% CI 1.1, 3.6)]. Those sustaining OASIS at VBAC were older (p = 0.011) and had infants of greater birth weight at initial caesarean (p < 0.001) and VBAC (p = 0.04). Analysis of odds ratios revealed that mediolateral episiotomy (MLE) at VBAC halved the risk of OASIS [37.5% VBAC with OASIS vs. 52.2% VBAC without OASIS (OR 0.51, 95% CI 0.32-0.81)], whereas an urgent CS at initial delivery doubled the risk [52.3% VBAC with OASIS vs. 34.9% VBAC without OASIS (OR 2.05, 95% CI 1.31-3.21)]. CONCLUSIONS: Advanced maternal age, increased infant birth weight and an urgent category of initial CS increase the risk of OASIS at VBAC, whereas MLE is protective.

Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials.

OBJECTIVES: To compare the effectiveness and safety of surgical interventions for women with stress urinary incontinence. DESIGN: Systematic review and network meta-analysis. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials evaluating surgical interventions for the treatment of stress urinary incontinence in women. METHODS: Identification of relevant randomised controlled trials from Cochrane reviews and the Cochrane Incontinence Specialised Register (searched May 2017), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Medline In-Process, Medline Epub Ahead of Print, CINAHL, ClinicalTrials.gov, and WHO ICTRP. The reference lists of relevant articles were also searched. Primary outcomes were "cure" and "improvement" at 12 months, analysed by means of network meta-analyses, with results presented as the surface under the cumulative ranking curve (SUCRA). Adverse events were analysed using pairwise meta-analyses. Risk of bias was assessed using the Cochrane risk of bias tool. The quality of evidence for network meta-analysis was assessed using the GRADE approach. RESULTS: 175 randomised controlled trials assessing a total of 21 598 women were included. Most studies had high or unclear risk across all risk of bias domains. Network meta-analyses were based on data from 105 trials that reported cure and 120 trials that reported improvement of incontinence symptoms. Results showed that the interventions with highest cure rates were traditional sling, retropubic midurethral sling (MUS), open colposuspension, and transobturator MUS, with rankings of 89.4%, 89.1%, 76.7%, and 64.1%, respectively. Compared with retropubic MUS, the odds ratio of cure for traditional sling was 1.06 (95% credible interval 0.62 to 1.85), for open colposuspension was 0.85 (0.54 to 1.33), and for transobtrurator MUS was 0.74 (0.59 to 0.92). Women were also more likely to experience an improvement in their incontinence symptoms after receiving retropubic MUS or transobturator MUS compared with other surgical procedures. In particular, compared with retropubic MUS, the odds ratio of improvement for transobturator MUS was 0.76 (95% credible interval 0.59 to 0.98), for traditional sling was 0.69 (0.39 to 1.26), and for open colposuspension was 0.65 (0.41 to 1.02). Quality of evidence was moderate for retropubic MUS versus transobturator MUS and low or very low for retropubic MUS versus the other two interventions. Data on adverse events were available mainly for mesh procedures, indicating a higher rate of repeat surgery and groin pain but a lower rate of suprapubic pain, vascular complications, bladder or urethral perforation, and voiding difficulties after transobturator MUS compared with retropubic MUS. Data on adverse events for non-MUS procedures were sparse and showed wide confidence intervals. Long term data were limited. CONCLUSIONS: Retropubic MUS, transobturator MUS, traditional sling, and open colposuspension are more effective than other procedures for stress urinary incontinence in the short to medium term. Data on long term effectiveness and adverse events are, however, limited, especially around the comparative adverse events profiles of MUS and non-MUS procedures. A better understanding of complications after surgery for stress urinary incontinence is imperative. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016049339.

Surgical treatments for women with stress urinary incontinence: the ESTER systematic review and economic evaluation.

BACKGROUND: Urinary incontinence in women is a distressing condition that restricts quality of life and results in a large economic burden to both the NHS and women themselves. OBJECTIVE: To evaluate the clinical effectiveness, safety and cost-effectiveness of surgical treatment for stress urinary incontinence (SUI) in women and explore women's preferences. DESIGN: An evidence synthesis, a discrete choice experiment (DCE) and an economic decision model, with a value-of-information (VOI) analysis. Nine surgical interventions were compared. Previous Cochrane reviews for each were identified and updated to include additional studies. Systematic review methods were applied. The outcomes of interest were 'cure' and 'improvement'. Both a pairwise and a network meta-analysis (NMA) were conducted for all available surgical comparisons. A DCE was undertaken to assess the preferences of women for treatment outcomes. An economic model assessed the cost-effectiveness of alternative surgeries and a VOI analysis was undertaken. RESULTS: Data from 175 studies were included in the effectiveness review. The majority of included studies were rated as being at high or unclear risk of bias across all risk-of-bias domains. The NMA, which included 120 studies that reported data on 'cure' or 'improvement', showed that retropubic mid-urethral sling (MUS), transobturator MUS, traditional sling and open colposuspension were more effective than other surgical procedures for both primary outcomes. The results for other interventions were variable. In general, rate of tape and mesh exposure was higher after transobturator MUS than after retropubic MUS or single-incision sling, whereas the rate of tape or mesh erosion/extrusion was similar between transobturator MUS and retropubic MUS. The results of the DCE, in which 789 women completed an anonymous online questionnaire, indicate that women tend to prefer surgical treatments associated with no pain or mild chronic pain and shorter length of hospital stay as well as those treatments that have a smaller risk for urinary symptoms to reoccur after surgery. The cost-effectiveness results suggest that, over a lifetime, retropubic MUS is, on average, the least costly and most effective surgery. However, the high level of uncertainty makes robust estimates difficult to ascertain. The VOI analysis highlighted that further research around the incidence rates of complications would be of most value. LIMITATIONS: Overall, the quality of the clinical evidence was low, with limited data available for the assessment of complications. Furthermore, there is a lack of robust evidence and significant uncertainty around some parameters in the economic modelling. CONCLUSIONS: To our knowledge, this is the most comprehensive assessment of published evidence for the treatment of SUI. There is some evidence that retropubic MUS, transobturator MUS and traditional sling are effective in the short to medium term and that retropubic MUS is cost-effective in the medium to long term. The VOI analysis highlights the value of further research to reduce the uncertainty around the incidence rates of complications. There is a need to obtain robust clinical data in future work, particularly around long-term complication rates. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016049339. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Urinary incontinence, defined as involuntary leakage of urine, is a common condition that varies in type and severity and can have a huge impact on the quality of life of women. The aim of this project was to summarise the evidence on the clinical effectiveness, safety and cost-effectiveness of nine surgical operations for stress urinary incontinence in women and assess the need for further research. Women's preferences for surgery were also explored. Currently there is no agreement among decision-makers, doctors and patients about which of the available surgical operations is best. Based on previous Cochrane reviews, the effects and safety of each operation were systematically reviewed and analysed. Their cost-effectiveness and the value of conducting further research were also evaluated. To better understand the preference of women, an online survey containing a discrete choice experiment was conducted. Finally, patient representatives were consulted to help us to understand the consequences of the findings from a patient's perspective. The evidence on surgical operations was predominantly short to medium term (up to 12 months). This analysis found that the quality of the evidence varied, with the majority of trials being subject to high or unclear risk of bias, making the conclusions that can be drawn less robust. The findings of the clinical evidence review suggest that retropubic sling procedures, transobturator sling procedures and traditional sling procedures are more effective than other surgical procedures for both 'cure' and 'improvement' of stress urinary incontinence. The results of the economic analyses support these findings, suggesting that retropubic mid-urethral sling is the most cost-effective surgical operation. However, data on complications were lacking, limiting any strong conclusions. The results suggest that there is value in undertaking further research to reduce the uncertainty around the medium- to long-term complications of all surgical treatments and this was reflected in patients' views.

National BSUG audit of stress urinary incontinence surgery in England.

INTRODUCTION AND HYPOTHESIS: The aim of the British Society of Urogynaecology (BSUG) 2013 audit for stress urinary incontinence (SUI) surgery was to conduct a national clinical audit looking at the intra- and postoperative complications and provide outcomes for these procedures. This audit was supported by the Healthcare Quality Improvement Partnership (HQIP) and National Health Service (NHS) England. METHODS: Data were collected for all continence procedures performed in 2013 through the BSUG database. All clinicians in England performing SUI surgery were invited to submit data to a central database. Outcomes data for the different continence procedures were collected and included intraoperative and postoperative complications and the change in continence scores at postoperative follow-up Changing trends in stress incontinence surgery were also assessed. RESULTS: We recorded 4993 urinary incontinence procedures from 177 consultants at 110 centres in England: 94.6% were midurethral slings; 86.7% (4331) were submitted by BSUG members with the remaining 13.3% submitted by non-BSUG members. Postoperative follow-up data were available for 3983 (80%) patients: 92.3% (3676) were very much better/much better postoperatively, and 4806 (96.3%) proceeded with no reported complications. There were 187 cases (3.7%) in which a perioperative complication was recorded. Pain persisting >30 days was reported in 1.9% of all patients. CONCLUSIONS: Surgery for SUI has good outcomes in the short term. Midurethral synthetic slings have been shown to be safe and effective as a treatment option, with >90% being very much/much better at their postoperative follow-up.

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence.

Urinary incontinence is a prevalent condition worldwide and causes a tremendous impact on a woman's quality of life. While conservative and non-surgical therapies are options for treatment, surgery for stress urinary incontinence (SUI) is common. Options include colposuspension, slings (pubovaginal and midurethral), and periurethral bulking. While evidence supports each of these options in the treatment of SUI, each is associated with various rates of success and unique adverse event profiles. Urgency urinary incontinence (UUI) is initially treated with behavioral modification and pharmacologic means, with surgery reserved for those with refractory symptoms or significant complications from medication use. At present, intravesical onabotulinumtoxinA injections, percutaneous tibial nerve stimulation, and sacral neurostimulation are all viable options for refractory UUI/overactive bladder. As with surgical interventions for SUI, each of these is, likewise, associated with unique outcomes and adverse event profiles. Herein, we summarize the findings and conclusions from the 6th International Consultation on Incontinence (ICI) regarding surgical treatment of urinary incontinence in women.

Bulkamid (PAHG) in mixed urinary incontinence: What is the outcome?

INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI), defined as mixed symptoms of stress urinary incontinence (SUI) and overactive bladder (OAB), is a difficult entity if conservative treatment has failed. Cure rates are low compared with SUI, particularly the OAB component, may deteriorate after sling insertion. Bulking agents pose an appealing alternative for the treatment of MUI. They have shown beneficial effect in small case studies, but larger series are lacking. The aim of this prospective study was an analysis of treatment efficacy and safety profile of the bulking agent, Bulkamid, in female patients with MUI. METHODS: One hundred fifty-four women with MUI symptoms (components of SUI/OAB within the limits of 60-40% either way) received bulking therapy with polyacrylamide hydrogel (Bulkamid). Patients were followed-up 3 months postoperatively. Primary outcome was the domain Incontinence impact on the King's Health Questionnaire (KHQ). Secondary outcomes were the other KHQ domains, visual analog scale (VAS), and International Continence Society (ICS) standardized pad weight test as objective measurement of incontinence. RESULTS: Statistically significant improvements were found for all KHQ domains, pad weight test, and the visual analog scale (VAS) before and after bulking. Overall complication rate was 13%. CONCLUSIONS: This study has shown improvement in MUI after bulking therapy according to both subjective and objective outcomes. We can advocate bulking therapy for treating MUI, as it is simple and safe and shows both objective and subjective improvement and relief. Long-term results (up to 1 year) are awaited.

Mesh removal after vaginal surgery: what happens in the UK?

INTRODUCTION AND HYPOTHESIS: There is little objective evidence regarding complication rates for mesh procedures outside clinical trials. Current coding poorly collects complications of prolapse and continence surgery using mesh. This survey was designed to identify surgeons performing mesh removal and reporting patterns in the UK. METHODS: An electronic questionnaire was sent to all members of the Royal College of Obstetricians and Gynaecologists and members of the Section of Female Neurological and Urodynamic Urology of the British Association of Urologists in the UK. The questionnaire aimed to identify the number of procedures performed for mesh complications and whether they were reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and the patterns of referral and treatment RESULTS: Referral to a colleague in the same hospital was common practice (69 %). Only 27 % of respondents stated that they reported all removals to the MHRA. The numbers of surgical procedures were low, with most respondents performing between one and three procedures each year and many not performing any surgery for a specific mesh complication in the previous year. CONCLUSIONS: Removal of exposed, eroded and/or painful vaginally inserted mesh is performed by many different surgeons in a variety of hospital settings in the UK.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female anorectal dysfunction.

INTRODUCTION: The terminology for anorectal dysfunction in women has long been in need of a specific clinically-based Consensus Report. METHODS: This Report combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted on Committee by experts in their fields to form a Joint IUGA/ICS Working Group on Female Anorectal Terminology. Appropriate core clinical categories and sub classifications were developed to give an alphanumeric coding to each definition. An extensive process of twenty rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A Terminology Report for anorectal dysfunction, encompassing over 130 separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-specific anorectal investigations and imaging (ultrasound, radiology and MRI) has been included whilst appropriate figures have been included to supplement and help clarify the text. Interval review (5-10 years) is anticipated to keep the document updated and as widely acceptable as possible. CONCLUSION: A consensus-based Terminology Report for female anorectal dysfunction terminology has been produced aimed at being a significant aid to clinical practice and a stimulus for research. Neurourol. Urodynam. 36:10-34, 2017. © 2016 Wiley Periodicals, Inc., and The International Urogynecological Association.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female anorectal dysfunction.

INTRODUCTION AND HYPOTHESIS: The terminology for anorectal dysfunction in women has long been in need of a specific clinically-based Consensus Report. METHODS: This Report combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted on Committee by experts in their fields to form a Joint IUGA/ICS Working Group on Female Anorectal Terminology. Appropriate core clinical categories and sub classifications were developed to give an alphanumeric coding to each definition. An extensive process of twenty rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A Terminology Report for anorectal dysfunction, encompassing over 130 separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-specific anorectal investigations and imaging (ultrasound, radiology and MRI) has been included whilst appropriate figures have been included to supplement and help clarify the text. Interval review (5-10 years) is anticipated to keep the document updated and as widely acceptable as possible. CONCLUSIONS: A consensus-based Terminology Report for female anorectal dysfunction terminology has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

Obesity and pelvic floor dysfunction.

Obesity is associated with a high prevalence of pelvic floor disorders. Patients with obesity present with a range of urinary, bowel and sexual dysfunction problems as well as uterovaginal prolapse. Urinary incontinence, faecal incontinence and sexual dysfunction are more prevalent in patients with obesity. Uterovaginal prolapse is also more common than in the non-obese population. Weight loss by surgical and non-surgical methods plays a major role in the improvement of these symptoms in such patients. The treatment of symptoms leads to an improvement in their quality of life. However, surgical treatment of these symptoms may be accompanied by an increased risk of complications in obese patients. A better understanding of the mechanism of obesity-associated pelvic floor dysfunction is essential.

Pelvic floor muscle training as an adjunct to prolapse surgery: a randomised feasibility study.

INTRODUCTION AND HYPOTHESIS: There is evidence that in nonsurgical populations, pelvic floor muscle training (PFMT) and lifestyle advice improves symptoms and stage of pelvic organ prolapse (POP). Some women, however, require surgery, after which de novo symptoms can develop or additional surgery is required due to recurrence. Robust evidence is required as to the benefit of perioperative PFMT in the postsurgery reduction of symptoms and POP recurrence. The aim of this study was to assess the feasibility of and collect pilot data to inform sample size (SS) calculation for a multicentre randomised controlled trial (RCT) of perioperative PFMT following surgical intervention for POP. METHODS: Fifty-seven participants were recruited and randomised to a treatment group (one pre and six postoperative PFMT sessions) or a control group (usual care). The primary outcome measure was the Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months; secondary outcome measures included measurement of prolapse, the pelvic floor and questionnaires relating to urinary and bowel incontinence. All outcomes were measured at 0, 6 and 12 months. RESULTS: Information on recruitment, retention and appropriateness of outcome measures for a definitive trial was gathered, and data enabled us to undertake an SS calculation. When compared with the control group (n = 29), benefits to the intervention group (n = 28) were observed in terms of fewer prolapse symptoms at 12 months [mean difference 3.94; 95 % confidence interval (CI) 1.35-6.75; t = 3.24, p = 0.006]; however, these results must be viewed with caution due to possible selection bias. CONCLUSION: With modifications to design identified in this pilot study, a multicentre RCT is feasible.

A systematic review of clinical studies of electrical stimulation for treatment of lower urinary tract dysfunction.

INTRODUCTION AND HYPOTHESIS: The aim of this manuscript was to provide a systematic literature review of clinical trial evidence for a range of electrical stimulation therapies in the treatment of lower urinary tract symptoms (LUTS). METHODS: The databases MEDLINE, BIOSIS Previews, Inside Conferences, and EMBASE were searched. Original clinical studies with greater than 15 subjects were included. RESULTS: Seventy-three studies were included, representing implanted sacral nerve stimulation (SNS), percutaneous posterior tibial nerve stimulation (PTNS), and transcutaneous electrical stimulation (TENS) therapy modalities. CONCLUSIONS: Median mean reductions in incontinence episodes and voiding frequency were similar for implanted SNS and PTNS. However, long-term follow-up data to validate the sustained benefit of PTNS are lacking. Despite a substantial body of research devoted to SNS validation, it is not possible to definitively define the appropriate role of this therapy owing largely to study design flaws that inhibited rigorous intention to treat analyses for the majority of these studies.

Sexual function after rectocele repair.

INTRODUCTION: Pelvic organ prolapse is a common condition among women with a prevalence of 11% and may affect the anterior, posterior, or apical compartment with a negative impact on sexual function. AIM: Aim of the current study was to evaluate sexual function before and after surgical rectocele fascial repair in sexually active patients who suffer from symptomatic rectoceles. MAIN OUTCOME MEASURES: Female Sexual Function Index (FSFI) and anatomical outcome after rectocele repair. METHODS: Between December 2000 and December 2009, we asked sexually active female patients who were to undergo rectocele fascial repair for symptomatic rectoceles to participate in this study. The patients were gynecologically examined before and after surgery and prolapse staging was performed using the ICS-Pelvic Organ Prolapse Staging. Patients were asked to fill in the FSFI before surgery and at 6 months follow-up. For statistical analysis, Graph Pad Prism version 5.0 for Windows was used (Graph Pad, La Jolla, CA, USA). Student's t-test was used after normality tests to compare groups and α was set 0.05. RESULTS: Sixty-eight patients were included in this study. Median age was 72 years (range 47-91), median parity of 2 (range 0-3) and median body mass index was 29 kg/m2 (range 23-31). Main complaints preoperatively were painful prolapse feeling (n=52), dyspareunia (n=59), and a feeling of vaginal heaviness (n=39). One patient who had suffered from postoperative infection that resulted in excessive scar tissue of the posterior wall suffered from de novo dyspareunia. Statistical analyses (paired t-test) showed significant improvement for desire (P<0.001), satisfaction (P<0.0001), and pain (P<0.0001) and no significant changes for arousal (P=0.0897), lubrication (P=1), and orgasm (P=0.0893). CONCLUSION: Posterior fascial repair improves some domains of sexual function but not all in sexually active patients with symptomatic rectoceles, and local oestrogene treatment may contribute to this finding.