Impact of the availability of midurethral slings on treatment strategies for stress urinary incontinence: a cost-effectiveness analysis.

OBJECTIVE: To perform a cost-effectiveness analysis for the surgical and non-surgical management of stress urinary incontinence (SUI) with and without the availability of midurethral sling. DESIGN: Cost-effectiveness analysis. SETTING: USA, 2019. POPULATION: Women with stress urinary incontinence. METHODS: We modelled SUI treatment pathways with and without the availability of midurethral slings, including no treatment, incontinence pessary, pelvic floor muscle physical therapy, urethral bulking injection, open and laparoscopic Burch colposuspension, and pubovaginal autologous sling. Time horizon was 2 years after initial treatment. MAIN OUTCOME MEASURES: Costs (2019 US$) included index surgery, surgical retreatment, and complications including urinary retention, de novo urgency and mesh exposure. The incremental cost-effectiveness ratio (ICER) was calculated for non-dominated treatment strategies. RESULTS: The least costly treatment strategies were incontinence pessary, pelvic floor physical therapy, no treatment and midurethral sling, respectively. Midurethral slings had the highest effectiveness. The strategy with the lowest effectiveness was no treatment. The three cost-effective strategies included pessary, pelvic floor muscle physical therapy and midurethral slings. No other surgical options were cost-effective. If midurethral slings were not available, all other surgical options were still dominated by pelvic floor muscle physical therapy. Multiple one-way sensitivity analyses confirmed model robustness. The only reasonable threshold in which outcomes would change, was if urethral bulking costs decreased 12.6%. CONCLUSIONS: The midurethral sling is the most effective SUI treatment and the only cost-effective surgical option. TWEETABLE ABSTRACT: Midurethral sling is the only cost-effective surgical treatment option for stress urinary incontinence.

Developing an Advanced Alternative Payment Model for Stress Urinary Incontinence.

ABSTRACT: Historically, our health care system has been based on a fee-for-service model, which has resulted in high-cost and fragmented care. The Center for Medicare & Medicaid Services is moving toward a paradigm in which health care providers are incentivized to provide cost-effective, coordinated, value-based care in an effort to control costs and ensure high-quality care for all patients. In 2015, the Medicare Access and Children's Health Insurance Program Reauthorization Act repealed the Sustainable Growth Rate and the fee-for-service model, replacing them with a 2-track system: Merit-based Incentive Payment System and the advanced Alternative Payment Model (aAPM) system. In 2016, the American Urogynecologic Society Payment Reform Committee was created and tasked with developing aAPMs for pelvic floor disorders. The purpose of this article is to describe the stress urinary incontinence aAPM framework, the data selected and associated data plan, and some of the challenges considered and encountered during the aAPM development.

Cost Analysis of Vaginal Anti-incontinence Procedures at a Tertiary Care Center.

OBJECTIVE: To compare the cost of 3 vaginal procedures used in the surgical management of stress urinary incontinence (SUI) at 1 tertiary institution. METHODS: The costs of autologous fascial sling (AFS), synthetic mid-urethral sling (MUS), and anterior vaginal wall suspension (AVWS) were analyzed from a prospective long-term database, with follow-up to 5 years after these procedures. Original costing data were obtained for operating room, medical and surgical supplies, pharmacy, anesthesia supplies, and room and bed over 2 consecutive years. Included were complete cost data provided by our institution from Medicare (2012) and private payer insurance. RESULTS: For the year 2013, the AVWS, AFS, and MUS had total median costs of $4513, $5721, and $3311, respectively. Total cost and all subcosts except for pharmacy costs were significantly different for each procedure. AVWS and MUS placement differed from each other regarding the cost of anesthesia and hospital stay, which was higher for AVWS. Compared to AFS, AVWS had significantly lower total costs due to decreased costs associated with operating time, hospital stay, and surgical supplies (P <.0001). At 5 years after these procedures, synthetic slings had less frequent follow-up visits. The most common revision for SUI failure was a bulking agent injection. CONCLUSION: Initial costs of vaginal SUI procedures at our institution fared favorably compared to SUI procedures reported in the contemporary US literature. Long-term costs can vary based on physician preference in follow-up routine and etiology of SUI.

Pure stress urinary incontinence: analysis of prevalence, estimation of costs, and financial impact.

BACKGROUND: The prevalence of pure stress urinary incontinence (P-SUI) and the role of urodynamic investigation (UDI) prior to surgery for stress urinary incontinence (SUI) is debated. Since the exact prevalence of P-SUI is not clear, its clinical and economic impact is not well defined. The aims of this study were to evaluate the prevalence of P-SUI in a population of women who underwent UDI for urinary incontinence (UI), also assessing: 1) the correspondence between clinical diagnosis of P-SUI and urodynamic findings; 2) the analysis of costs in terms of UDI and eventually post-UDI avoided surgical procedures. METHODS: A single cohort of women who underwent UDI for UI between January 2012 and July 2016 was prospectively collected and retrospectively analyzed. Clinical P-SUI was defined by the strict criteria of the International Continence Society. For each patient, history, physical examination and UDI were collected. The correspondence between clinical and urodynamic findings of P-SUI was analyzed. The rate of clinical P-SUI changed after performing UDI and the number of unnecessary intervention after UDI were reported. A wide cost analysis of UDIs, and the amount of surgical procedures that were believed unnecessary after UDI was reported. RESULTS: Stress urinary incontinence was present in 323/544 (59.4%) patients. The prevalence of clinical P-SUI was 20.7% (67/323), while the prevalence of complicated SUI (C-SUI) was 79.3% (256/323). After UDI, diagnosis of P-SUI decreased to 18.3% (59/232). In 10.2% of cases (6/59) the scheduled middle urethral sling (MUS) was suppressed after the UDI results because 3/6 cases had detrusor overactivity and urge incontinence, in 2/6 cases SUI was treated with a conservative management, in 1/6 case an important voiding dysfunction was detected. Considering the national reimbursement in our country, the cost of each UDI was 296.5 euros and the total amount was 17,493.5 euros. So far the surgery-related savings covered 61.7-105.0% of the costs of total number of UDIs performed in the uncomplicated patients. CONCLUSIONS: The prevalence of clinical P-SUI is relevant, involving about 20% of women with clinical SUI. Although the correspondence between clinical and urodynamic diagnosis was high, we demonstrated that UDI may help in some cases to avoid an inappropriate surgical treatment. Therefore, UDI prior to SUI surgery should be considered to achieve a correct diagnosis and a proper therapeutic strategy.

Heterogeneity of cost estimates in health economic evaluation research. A systematic review of stress urinary incontinence studies.

INTRODUCTION AND HYPOTHESIS: There is increased demand for an international overview of cost estimates and insight into the variation affecting these estimates. Understanding of these costs is useful for cost-effectiveness analysis (CEA) research into new treatment modalities and for clinical guideline development. METHODS: A systematic search was conducted in Ovid MEDLINE & other non-indexed materials and Ovid Embase for articles published between 1995 and 2017. The National Health Service Economic Evaluation Database (NHS-EED) filter and the McMaster sensitive therapy filter were combined with a bespoke search strategy for stress urinary incontinence (SUI). We extracted unit cost estimates, assessed variability and methodology, and determined transferability. RESULTS: We included 37 studies in this review. Four hundred and eighty-two cost estimates from 13 countries worldwide were extracted. Descriptive analysis shows that hospital stay in gynecology ranged between €82 and €1,292 per day. Costs of gynecological consultation range from €30 in France to €158 in Sweden. In the UK, costs are estimated at €228 per hour. Costs of a tension-free vaginal tape (TVT) device range from €431 in Finland to €994 in Canada. TVT surgery per minute costs €25 in France and €82 in Sweden. Total costs of TVT range from €1,224 in Ireland to €5,809 for inpatient care in France. Variation was explored. CONCLUSIONS: Heterogeneity was observed in cost estimates for all units at all levels of health care. CEAs of SUI interventions cannot be interpreted without bias when the base of these analyses-namely costs-cannot be compared and generalized.

Cell-based therapy for the treatment of female stress urinary incontinence: an early cost-effectiveness analysis.

AIM: To perform an early cost-effectiveness analysis of in vitro expanded myoblasts (IVM) and minced myofibers versus midurethral slings (MUS) for surgical treatment of female stress urinary incontinence. METHODS: Cost-effectiveness and sensitivity analyses were performed using a decision tree comprising previously published data and expert opinions. RESULTS & CONCLUSION: In the base case scenario, MUS was the cost-effective strategy with a negative incremental cost-effectiveness ratio compared with IVM and a positive incremental cost-effectiveness ratio compared with minced myofibers. However, the sensitivity analysis indicates that IVM may become an alternative providing greater effect at a higher cost. With the possibility of becoming more effective, IVM treatment would be advantageous over MUS given its reduced invasiveness and lower risks of complications.

A cost-utility analysis of artificial urinary sphincter versus AdVance male sling in post prostatectomy stress urinary incontinence: A publicly funded health care perspective.

AIMS: To investigate the long-term cost-utility of the artificial urinary sphincter (AUS) compared with Transobturator Retroluminal Sling (AdVance) in the treatment of patients with severe post prostatectomy stress urinary incontinence (PPSUI) from a Canadian provincial health perspective. METHODS: A Markov model with Monte Carlo simulation was developed with a cycle length of 1 year and time horizon up to 10 years to estimate the incremental cost per quality-adjusted life years (QALYs). Patients were assigned to treatment with either AUS or an AdVance sling. Transition probabilities, efficacy data, and utility indices were derived from published literature and expert opinion. Cost data were obtained from provincial health care system and hospital data in 2016-Canadian dollars. The primary outcome was cost per quality-adjusted life year. A standard discount rate of 1.5% was applied annually. Probabilistic and one way deterministic sensitivity analyses were performed. RESULTS: AUS implantation had a 10-year mean total cost of $14 228 (SD ± 3,509) for 7.58 QALYs. AdVance sling had a mean total cost $18 938 (SD ± 12,435) for 6.43 QALYs. The incremental cost savings of AUS over 10-years was -$ 4710 with an added effectiveness of 1.15 QALYs. At a willingness to pay threshold of $50 000, AUS remained the most cost-effective option. A limitation of our analysis is the lack of direct long-term comparisons between both scenarios along with standard success definition. CONCLUSIONS: AUS implantation appears to be more economical treatment strategy for severe PPSUI compared with AdVance sling for a publicly funded health care system over a 5- and 10-year time horizon.

Costs analysis of surgical treatment of stress urinary incontinence in a brazilian public hospital, comparing Burch and synthetic sling techniques

ABSTRACT Introduction Surgical treatment of urinary incontinence progressed significantly with the introduction of synthetic slings. However, in some public Brazilian hospitals, the costs of these materials prevent their routine use. Objective To compare the costs of ambulatory synthetic sling surgery with an historical series of patients submitted to Burch surgery in a Brazilian public hospital. Materials and Methods Twenty nine incontinent patients were selected to synthetic sling surgery. Demographic data were prospectively collected and also the costs of the procedure, including drugs and materials, use of surgical and recovery wards, medical staff and hospitalization. These data were compared to the costs of 29 Burch surgeries performed before the introduction of synthetic slings. Results Demographic data were similar, although median age was lower in the group submitted to Burch surgery (46.3±8.6 versus 56.2±11.3 (p<0.001)). Cost was significantly lower in patients submitted to sling in all items, except for time spent in recovery ward. Total value of 29 Burch surgeries was R$ 217.766.12, and of R$ 68.049.92 of 29 patients submitted to sling surgery (p<0.001). Conclusion Burch surgery was more expensive than ambulatory synthetic transobturator sling surgery, even when the cost of the synthetic sling was considered.

Costs analysis of surgical treatment of stress urinary incontinence in a brazilian public hospital, comparing burch and synthetic sling techniques.

INTRODUCTION: Surgical treatment of urinary incontinence progressed significantly with the introduction of synthetic slings. However, in some public Brazilian hospitals, the costs of these materials prevent their routine use. OBJECTIVE: To compare the costs of ambulatory synthetic sling surgery with an historical series of patients submitted to Burch surgery in a Brazilian public hospital. MATERIALS AND METHODS: Twenty nine incontinent patients were selected to synthetic sling surgery. Demographic data were prospectively collected and also the costs of the procedure, including drugs and materials, use of surgical and recovery wards, medical staff and hospitalization. These data were compared to the costs of 29 Burch surgeries performed before the introduction of synthetic slings. RESULTS: Demographic data were similar, although median age was lower in the group submitted to Burch surgery (46.3±8.6 versus 56.2±11.3 (p<0.001)). Cost was significantly lower in patients submitted to sling in all items, except for time spent in recovery ward. Total value of 29 Burch surgeries was R$ 217.766.12, and of R$ 68.049.92 of 29 patients submitted to sling surgery (p<0.001). CONCLUSION: Burch surgery was more expensive than ambulatory synthetic transobturator sling surgery, even when the cost of the synthetic sling was considered.

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial.

INTRODUCTION: Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. METHODS AND ANALYSIS: A pragmatic, multicentre, non-inferiority randomised controlled trial. PRIMARY OUTCOME MEASURE: The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. SECONDARY OUTCOME MEASURES: The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. STATISTICAL ANALYSIS: The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. ETHICS AND DISSEMINATION: The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. TRIAL REGISTRATION NUMBER: ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

BACKGROUND: Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app. OBJECTIVE: The objective of this study was to evaluate the health economy of the app for treating SUI. METHODS: This deterministic cost-utility analysis, with a 1-year societal perspective, compared the app treatment with no treatment. Health economic data were collected alongside a randomized controlled trial performed in Sweden from March 2013 to October 2014. This study included 123 community-dwelling women participants of 18 years and above, with stress urinary incontinence ≥1 time per week. Participants were self-assessed with validated questionnaires and 2-day leakage diaries, and then randomized to 3 months of treatment (app group, n=62) or no treatment (controls, n=61). The app focused on pelvic floor muscle training, prescribed 3 times daily. We continuously registered treatment delivery costs. Data were collected on each participant's training time, incontinence aids, and laundry at baseline and at a 3-month follow-up. We measured quality of life with the International Consultation on Incontinence Modular Questionnaire on Lower Urinary Tract Symptoms and Quality of Life, and calculated the quality-adjusted life years (QALYs) gained. Data from the 3-month follow-up were extrapolated to 1 year for the calculations. Our main outcome was the incremental cost-effectiveness ratios compared between app and control groups. One-way and multiway sensitivity analyses were performed. RESULTS: The mean age of participants was 44.7 years (SD 9.4). Annual costs were €547.0 for the app group and €482.4 for the control group. Annual gains in quality-adjusted life years for app and control groups were 0.0101 and 0.0016, respectively. Compared with controls, the extra cost per quality-adjusted life year for the app group ranged from -€2425.7 to €14,870.6, which indicated greater gains in quality-adjusted life years at similar or slightly higher cost. CONCLUSIONS: The app for treating stress urinary incontinence is a new, cost-effective, first-line treatment with potential for increasing access to care in a sustainable way for this patient group.

Surgical treatment of stress urinary incontinence-trans-obturator tape compared with tension-free vaginal tape-5-year follow up: an economic evaluation.

OBJECTIVE: To conduct an economic evaluation of the use of trans-obturator tape (TOT) compared with tension-free vaginal tape (TVT) in the surgical treatment of stress urinary incontinence in women. DESIGN: Cost-utility and cost-effectiveness analyses from a public-payer perspective, conducted alongside a randomised clinical trial. SETTING: Health services provided in Alberta, Canada. SAMPLE: A total of 195 women participated in the randomised clinical trial, followed to 5 years postsurgery. METHODS: Comparisons were undertaken between study groups for cost and two health-outcome measures. Multiple imputation was used to estimate the 14% of missing data. Bootstrapping was used to account for sampling uncertainty. Sensitivity analyses were based on complete case analyses and the removal of a TVT patient with extreme health service cost. MAIN OUTCOME MEASURES: The 15D instrument was used to calculate quality-adjusted life-years (QALYs) for the primary analysis. Absence of serious adverse events was also analysed. Costs were based on inpatient and outpatient hospital use data and practitioner fee-for-service claims data. RESULTS: The TOT group had a nonsignificant average saving of $2368 (95% CI -$7166 to $2548) and incremental gain of 0.04 QALYs (95% CI -0.06 to 0.14) compared with TVT. TOT was dominant in over 71% of bootstrap replications and cost-effective over a wide range of willingness-to-pay. Cost-effectiveness analysis using the absence of an serious adverse events provided similar results. CONCLUSION: The results suggest that TOT is cost-effective compared with TVT in the treatment of stress urinary incontinence. TWEETABLE ABSTRACT: The results of a 5-year cost-effectiveness analysis suggest that trans-obturator tape is cost-effective compared with tension-free vaginal tape in the treatment of stress urinary incontinence.

Preoperative Testing for Urethral Sling Surgery for Stress Urinary Incontinence: Overuse, Underuse and Cost Implications.

PURPOSE: We identify areas of overuse and underuse in the preoperative evaluation of patients undergoing mid urethral sling surgery. We also estimate the effect of overuse of preoperative testing on health care costs. MATERIALS AND METHODS: We conducted a retrospective review of women who underwent sling surgery with or without concomitant prolapse repair between 2012 and 2013. Physician orders for preoperative electrocardiogram, chest x-ray, basic metabolic panel, complete blood count, coagulation studies and urinalysis were classified as appropriate or inappropriate based on summary guidelines from the American Academy of Family Physicians. The additional costs of inappropriate tests were estimated using the 2014 Medicare clinical laboratory and physician fee schedules. RESULTS: A total of 101 women who underwent mid urethral sling surgery were identified and 346 preoperative tests were ordered. Overall 76% of coagulation profiles, 73% of complete blood counts, 47% of basic metabolic panels, 39% of chest x-rays and 21% of electrocardiograms ordered did not have an appropriate clinical indication. In addition, 6% of electrocardiograms, 22% of chest x-rays and 10% of urinalyses were not ordered despite an appropriate indication. The estimated charges of overused tests were $1,844.15 for the cohort, or $18 per patient. CONCLUSIONS: Preoperative testing is overused as well as underused in patients undergoing sling surgery. The greatest variation occurred with the use of electrocardiograms, chest x-rays and urinalysis. Poor adherence to national guidelines leads to increased health care costs and warrants increased awareness in following evidence-based guidelines.

The cost of preoperative urodynamics: A secondary analysis of the ValUE trial.

AIMS: Urodynamic studies (UDS) are generally recommended prior to surgical treatment for stress urinary incontinence (SUI), despite insufficient evidence that it impacts treatment plans or outcomes in patients with uncomplicated SUI. This analysis aimed to calculate the cost incurred when UDS was performed as a supplement to a basic office evaluation and to extrapolate the potential savings of not doing UDS in this patient population on a national basis. METHODS: This is a secondary analysis from the Value of Urodynamic Evaluation (ValUE) trial, a multicenter non-inferiority randomized trial to determine whether a basic office evaluation (OE) is non-inferior in terms of SUI surgery outcomes to office evaluation with addition of urodynamic studies (UDS). All participants underwent an OE; those patients who randomized to supplementary UDS underwent non-instrumented uroflowmetry, filling cystometry, and a pressure flow study. Costs associated with UDS were calculated using 2014 U.S. Medicare allowable fees. Models using various patient populations and payor mixes were created to obtain a range of potential costs of performing UDS in patients undergoing SUI surgery annually in the United States. RESULTS: Six hundred thirty women were randomized to OE or OE plus UDS. There was no difference in surgical outcomes between the two groups. The per patient cost of UDS varied from site to site, and included complex cystometrogram $314-$343 (CPT codes 51728-51729) plus complex uroflowmetry $16 (CPT code 51741). Extrapolating these costs for US women similar to our study population, 13-33 million US dollars could be saved annually by not performing preoperative urodynamics. CONCLUSION: For women with uncomplicated SUI and a confirmatory preoperative basic office evaluation, tens of millions of dollars US could be saved annually by not performing urodynamic testing. In the management of such women, eliminating this preoperative test has a major economic benefit.

Economic analyses of stress urinary incontinence surgical procedures in women.

INTRODUCTION: To evaluate the quality of economic analysis (EA) of surgical procedures for stress urinary incontinence (SUI) in women. METHODS: A MEDLINE search on EA for SUI surgical procedures for the years 2000-2014 included the MeSH terms "tension-free vaginal tape," "TVT," "trans-obturator tape," "TOT," "Burch colposuspension" (BC), "stress urinary incontinence," "economic analysis," and "cost-effectiveness analysis." Important criteria for evaluating articles were selected from panels that set out criteria to evaluate EA [Scales CD, Jr., Christopher SS, American Urological Association 32:121-128, 2013], [Hsieh MH, Maxwell MV, J Urol 178 1867-1874, 2007], [Wu JM, Catherine CM, Conover MM, et al., Obstet Gynecol 123 1201-1206, 2014]. RESULTS: Thirteen articles were identified: TVT compared to BC (6), to other surgical procedures for SUI (1), to TOT (3) and to the mini-sling (1); open BC compared to laparoscopic BC (1), and analysis of various slings and meshes for various types of incontinence (1). Articles originated from: United States (3), Europe (4), United Kingdom (4), and Canada (2). Eight described cost-effectiveness analysis (CEA), two cost-utility analysis, and three cost comparison. Follow-up time for patients ranged from 6 to 24 months in eight articles, with four having a minimum of 24 months follow-up. Studies mostly adhered to the criteria, however indirect costs, sensitivity analysis, and efficacy parameters varied. Long-term synthetic sling-related complications were not included. CONCLUSION: Although CEA for SUI surgery is a burgeoning field, study comparisons remain difficult due to some variability, including health care delivery systems. As women live longer, long-term data will become critical as complications and reoperations can affect the real cost of SUI corrective procedures. Neurourol. Urodynam. 35:1040-1045, 2016. © 2015 Wiley Periodicals, Inc.

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.

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial.

BACKGROUND: There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence. METHODS/DESIGN: One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence-related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed. DISCUSSION: This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01924728. Date of Registration: 14 August 2013.

Cost utility analysis of urethral bulking agents versus midurethral sling in stress urinary incontinence.

OBJECTIVE: The aim of this study was to determine the cost utility of urethral bulking agents (BA) compared with midurethral slings (MUS) in the treatment of stress urinary incontinence (SUI) in patients without urethral hypermobility. METHODS: A decision tree was constructed to compare the cost utility of urethral BA versus MUS in the setting of SUI without urethral hypermobility. Probability estimates for success, failure, and complications were obtained from the published literature. Immediate-term, short-term, and longer-term complications were accounted for over a 1-year time horizon in the model. One-way and 2-way sensitivity analyses and Monte Carlo simulations were performed to assess the robustness of our results. RESULTS: Our model demonstrated that MUS cost $436,465 more than BA for every 100 women treated in 1 year. Using MUS compared with BA leads to an incremental cost-effectiveness ratio of $70,400 per utility gained. Assuming a willingness to pay of $50,000, this makes MUS not cost-effective as a first-line treatment in many situations. When MUS costs less than $5132, it becomes a cost-effective first-line treatment, and when it costs less than $2035, it is cost saving. CONCLUSIONS: Bulking agents are more cost-effective than MUS over a 1-year time horizon in the treatment of SUI in patients without urethral hypermobility. In women who lack urethral hypermobility, BA remain a cost-effective option in this patient population.

Cost utility of the treatment of stress urinary incontinence.

OBJECTIVE: We sought to investigate the cost utility of nonsurgical versus surgical treatments for stress urinary incontinence (SUI). METHODS: A decision analysis model was created to compare nonsurgical and surgical treatment options for women with SUI. Decision paths included conservative management, pelvic floor physical therapy (pelvic floor muscle training [PFMT]), PFMT with electrical stimulation, incontinence pessary, and surgical treatment. A Markov model cohort analysis was performed with a cycle length of 1 year starting at age 45 years with a lifetime horizon. Probabilities, success rates, and utilities were obtained from the literature when available or by expert opinion. Cost-utility analysis was performed using US recommendations from a societal perspective. Cost data were obtained from Medicare reimbursement in 2012 US dollars. RESULTS: Incontinence pessary was the most cost-effective treatment option with a cost of $11,411 for 18.9 quality-adjusted life years. At a willingness to pay (WTP) threshold of $50,000, incontinence pessary remained the most cost-effective treatment option. At a WTP threshold of $60,000, surgery became the most cost-effective treatment option. The PFMT and PFMT with electrical stimulation were dominated at any WTP threshold. CONCLUSIONS: Surgical correction is likely the most cost-effective treatment option for young healthy women with SUI. Results are driven by the high success rate of minimally invasive slings. More studies are needed to define utility values for heath states experienced by women with SUI. This will enhance our ability to develop more accurate cost-utility models and offer the best treatment for women affected by incontinence.