Background:Overactive bladder is a common problem affecting the United Kingdom adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. Initial conservative treatments for overactive bladder are unsuccessful in 25-40% of women (refractory overactive bladder). Before considering invasive treatments, such as botulinum toxin injection-A or sacral neuromodulation, guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity. However, the clinical and cost effectiveness of urodynamics has never been robustly assessed. Objectives:To compare the clinical and cost effectiveness of urodynamics plus comprehensive clinical assessment versus comprehensive clinical assessment only in the management of refractory overactive bladder in women. Design:Parallel-group, multicentre, superiority, open-label, randomised controlled trial. Allocation by remote web-based randomisation (1 : 1 ratio). The cost-effectiveness analysis took the National Health Service perspective with a model-based lifetime time horizon, as informed by a within-trial analysis. Setting:Sixty-three United Kingdom secondary and tertiary hospitals. Participants:Women aged ≥ 18 years with refractory overactive bladder or urgency-predominant mixed urinary incontinence who had failed conservative management and pharmacological treatment and were being considered for invasive treatment. Women were excluded if any of the following criteria were met: predominant stress urinary incontinence; previous urodynamics in last 12 months; current pelvic malignancy or clinically significant pelvic mass; bladder pain syndrome; neurogenic bladder; urogenital fistulae; previous treatment with botulinum toxin injection-A or sacral neuromodulation for urinary incontinence; previous pelvic radiotherapy; prolapse beyond introitus; pregnant or planning pregnancy; recurrent urinary tract infection where a significant pathology has not been excluded; and inability to give an informed consent. Interventions:Urodynamics plus comprehensive clinical assessment (urodynamics arm) versus comprehensive clinical assessment only. Main outcome measures:Participant-reported success at the last follow-up time point as measured by the Patient Global Impression of Improvement. Primary economic outcome was incremental cost per quality-adjusted life-year gained as modelled over the lifetime of participants. Results:A total of 1099 participants were included: 550 randomised to the urodynamics arm and 549 to the comprehensive clinical assessment only arm. At the final follow-up time point, participant-reported success rates of 'very much improved' and 'much improved' were not superior in the urodynamics arm (117 participants; 23.6%) compared to the comprehensive clinical assessment only arm (114 participants; 22.7%) [adjusted odds ratio 1.12 (95% confidence interval 0.73 to 1.74); p = 0.601]. Serious adverse events were low and similar between groups. Based on the estimated incremental costs and quality-adjusted life-years of urodynamics (£463 and 0.011, respectively), the incremental cost-effectiveness ratio was £42,643 per quality-adjusted life-year gained. The cost-effectiveness acceptability curve shows that urodynamics has a 34% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. This probability reduced further when the results were extrapolated over the patient's lifetime. Limitations include: only short-term outcomes were available, and as most participants underwent botulinum toxin injection-A treatment, pre-planned secondary analyses for some outcomes such as sacral neuromodulation were not possible. Conclusion:Participant-reported success in the urodynamics arm was not superior to the comprehensive clinical assessment only arm at 15-months follow-up. Urodynamics is not cost-effective at a threshold of £20,000 per quality-adjusted life-year gained. Longer-term follow-up is required to explore need for further interventions and treatments and their effect on the clinical and cost-effectiveness analyses. Trial registration:This trial is registered as ISRCTN63268739. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/150/05) and is published in full in Health Technology Assessment Vol. 29, No. 27. See the NIHR Funding and Awards website for further award information.

BACKGROUND:Overactive bladder is a common problem affecting women worldwide, with a negative effect on their social and professional lives. Before considering invasive treatments, guidelines recommend urodynamics to identify detrusor overactivity. However, the clinical-effectiveness and cost-effectiveness of urodynamics has never been robustly assessed in this cohort of women. We aimed to compare the clinical-effectiveness and cost-effectiveness of urodynamics plus comprehensive clinical assessment (CCA) versus CCA only in the management of women with refractory overactive bladder symptoms. METHODS:We did a multicentre, superiority, parallel, open-label, randomised controlled trial in 63 UK hospitals. Women aged 18 years or older with refractory overactive bladder or urgency predominant mixed urinary incontinence, with failed conservative management and being considered for invasive treatment, were randomly assigned (1:1) to urodynamics plus CCA versus CCA only. Assignment used an internet-based application with stratified random permuted blocks and site and baseline diagnosis as stratum. Primary outcome was participant-reported success at the last follow-up timepoint, measured by the Patient Global Impression of Improvement at 15 months after randomisation. Primary economic outcome was incremental cost per quality-adjusted life-year (QALY) gained modelled over the participants lifetime. Analysis was based on the intention-to-treat principle. This study is registered with ISRCTN registry (ISRCTN63268739). FINDINGS:Between Nov 6, 2017, and March 1, 2021, 1099 participants were randomly assigned to urodynamics plus CCA (n=550) or CCA only (n=549). At the final follow-up timepoint, participant-reported success rates of "very much improved" and "much improved" were not superior in the urodynamics plus CCA group (117 [23·6%] of 496) versus the CCA-only group (114 [22·7%] of 503; adjusted odds ratio 1·12 [95% CI 0·73-1·74]; p=0·60). Serious adverse events were low and similar between groups. Incremental cost-effectiveness ratio was £42 643 per QALY gained. The cost-effectiveness acceptability curve showed urodynamics had a 34% probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY gained, which reduced further when extrapolated over the patient's lifetime. INTERPRETATION:In women with refractory overactive bladder or urgency predominant mixed urinary incontinence, the participant-reported success in the urodynamics plus CCA group was not superior to the CCA-only group, and urodynamics was not cost-effective at the £20 000 per QALY gained threshold. FUNDING:UK National Institute for Health and Care Research Health Technology Assessment Programme.

Background Overactive bladder (OAB) syndrome is a symptom complex affecting 12–14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women’s social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25–40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only . Methods FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. Discussion The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. Trial registration ISRCTN63268739. Registered on 14 September 2017.

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.

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.

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.

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.

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.

Background A healthy urinary system is vital to every woman's life, and the relationship between childbirth and bladder dysfunction has been well documented in the medical literature. Aims To explore women's bladder care experiences during the antepartum, intrapartum, and postpartum periods. Methods An exploratory, descriptive research study with nine in-depth semi-structured interviews. Findings Thematic analysis showed three themes: ‘muddling through to earn “a badge of honour”’, ‘caring for a baby, but who cares for me?’ and ‘do you speak bladder language?’ with an overarching theme of ‘lack of bladder care’. Women's experiences reflected a lack of understanding, information, and promotion regarding bladder care, aggravated by the use of ambiguous language when professionals communicated with women about bladder health. Conclusions Bladder care was very limited for women during the antepartum, intrapartum and postpartum period although reports of urinary incontinence were frequent. Bladder care could therefore be characterised as ‘lack of bladder care’. Clinicians should become more proactive in delivering information and promoting bladder health during these periods but that attention needs to be paid to communication methods.

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 27997 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 100000 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 100000 women/year. Risk-adjusted rates ranged from 20 to 106 procedures per 100000 women/year across CCGs and 24 to 69 procedures per 100000 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.

This chapter provides a detailed description of the modelling approach, the estimation of input parameters used to populate the model and the key assumptions underpinning the cost-effectiveness results. The results from the economic model are presented in two sections. In the first section, the results of the economic model are presented. In the second section, results from a VOI analysis, which can be used to aid decisions about the direction of further research, are presented (see Chapter 5, Summary). The chapter concludes with a summary of the results for all comparators and of the factors deemed to be most critical in affecting the cost-effectiveness of different surgical treatments for SUI and stress-predominant MUI.

Repeat continence surgery. Ant repair, anterior vaginal repair; ES, effect estimate (OR); lap colpo, laparoscopic colposuspension; open colpo, open colposuspension; retro-MUS, retropubic mid-urethral sling; single incision, single-incision sling; trad sling, traditional sling; transob-MUS, transobturator mid-urethral sling.

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.

InterventionsThe interventions detailed below were deemed suitable for inclusion. There are a number of variations on most surgical techniques, but, essentially, they fall into nine distinct categories, each of which has been previously evaluated in systematic reviews published in The Cochrane Library:

MethodsIn addition to the review of the clinical effectiveness of surgical treatments for SUI, a review of full model-based economic evaluations was conducted. The purpose of the review of model-based evaluations was to identify robust models and inputs to inform the economic modelling in this study. Specifically, the objective was to perform a critique of existing economic models to identify a model suitable for augmentation or to justify the development of a new economic model. Additionally, the review would be used to identify clinical and health economic data that were used in the identified models that could also be used in a new economic model. Trial-based economic evaluations were not included in the review to minimise the time commitment required for this aspect of the work. The review work was conducted in accordance with the Centre for Reviews and Dissemination’s guidance for undertaking reviews …

MethodsThe methods that were employed in the DCE study were informed by the Lancsar and Louviere 205 and Ryan and Gerard 211 reviews of the applications of DCEs in health care, considered to provide best practice guidance for DCEs. The methods can be broken down into four key steps: step 1–identification of attributes and levels; step 2–experimental design; step 3–data collection; and step 4–data analysis and interpretation. Details of the four steps, with regard to the current study, are provided below.

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. 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. 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)]. 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.