Medium-Term Outcomes of Conservative and Surgical Treatments for Stress Urinary Incontinence: A Medicare Claims Analysis: Developed by the AUGS Payment Reform Committee.

OBJECTIVE: This study aimed to evaluate the 3- to 5-year retreatment outcomes for conservatively and surgically treated urinary incontinence (UI) in a population of women 66 years and older. METHODS: This retrospective cohort study used 5% Medicare data to evaluate UI retreatment outcomes of women undergoing physical therapy (PT), pessary treatment, or sling surgery. The data set used inpatient, outpatient, and carrier claims from 2008 to 2016 in women 66 years and older with fee-for-service coverage. Treatment failure was defined as receiving another UI treatment (pessary, PT, sling, Burch urethropexy, or urethral bulking) or repeat sling. A secondary analysis was performed where additional treatment courses of PT or pessary were also considered a treatment failure. Survival analysis was used to evaluate the time from treatment initiation to retreatment. RESULTS: Between 2008 and 2013, 13,417 women were included with an index UI treatment, and follow-up continued through 2016. In this cohort, 41.4% received pessary treatment, 31.8% received PT, and 26.8% underwent sling surgery. In the primary analysis, pessaries had the lowest treatment failure rate compared with PT (P<0.001) and sling surgery (P<0.001; survival probability, 0.94 [pessary], 0.90 [PT], 0.88 [sling]). In the analysis where retreatment with PT or a pessary was considered a failure, sling surgery had the lowest retreatment rate (survival probability, 0.58 [pessary], 0.81 [PT], 0.88 [sling]; P<0.001 for all comparisons). CONCLUSIONS: In this administrative database analysis, there was a small but statistically significant difference in treatment failure among women undergoing sling surgery, PT, or pessary treatment, but pessary use was commonly associated with the need for repeat pessary fittings.

Comprehensive pelvic muscle assessment: Developing and testing a dual e-Learning and simulation-based training program.

OBJECTIVE: The Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium launched the RISE FOR HEALTH (RISE) national study of women's bladder health which includes annual surveys and an in-person visit. For the in-person exam, a standardized, replicable approach to conducting a pelvic muscle (PM) assessment was necessary. The process used to develop the training, the products, and group testing results from the education and training are described. METHODS: A comprehensive pelvic muscle assessment (CPMA) program was informed by literature view and expert opinion. Training materials were prepared for use on an electronicLearning (e-Learning) platform. An in-person hands-on simulation and certification session was then designed. It included a performance checklist assessment for use by Clinical Trainers, who in collaboration with a gynecology teaching assistant, provided an audit and feedback process to determine Trainee competency. RESULTS: Five discrete components for CPMA training were developed as e-Learning modules. These were: (1) overview of all the clinical measures and PM anatomy and examination assessments, (2) visual assessment for pronounced pelvic organ prolapse, (3) palpatory assessment of the pubovisceral muscle to estimate muscle integrity, (4) digital vaginal assessment to estimate strength, duration, symmetry during PM contraction, and (5) pressure palpation of both myofascial structures and PMs to assess for self-report of pain. Seventeen Trainees completed the full CPMA training, all successfully meeting the a priori certification required pass rate of 85% on checklist assessment. CONCLUSIONS: The RISE CPMA training program was successfully conducted to assure standardization of the PM assessment across the PLUS multicenter research sites. This approach can be used by researchers and healthcare professionals who desire a standardized approach to assess competency when performing this CPMA in the clinical or research setting.

Transition to surgery after pessary among female Medicare beneficiaries with pelvic organ prolapse.

BACKGROUND: The American College of Obstetricians and Gynecologists recommends offering a vaginal pessary to women seeking treatment of pelvic organ prolapse. However, single-institution series have suggested that a sizable proportion of women fitted with a pessary will transition to surgery within the first year. OBJECTIVE: This study aimed to estimate the proportion of female US Medicare beneficiaries with pelvic organ prolapse who undergo surgery after pessary fitting, to describe the median time to surgery from pessary fitting, and to identify factors associated with the transition from pessary to surgery. STUDY DESIGN: The Medicare 5% Limited Data Set was queried from 2011 to 2016 for women aged ≥65 years with a diagnosis of prolapse who underwent pessary fitting. Cases with at least 3 years of follow-up in the Medicare Data Set were followed longitudinally for the primary outcome of surgery for prolapse. The cumulative incidence of prolapse surgery following index pessary fitting was calculated. Characteristics of women who underwent surgery and those who did not were compared using time-varying Cox regression analysis. RESULTS: Among 2032 women fitted with a pessary, 608 underwent surgery within 7 years. The median time to surgery was 496 days (interquartile range, 187-1089 days). The cumulative incidence of prolapse surgery was 12.2% at 1 year and 30.9% at 7 years. After adjusting for covariates, factors significantly associated with the transition to surgery included previous prolapse surgery (adjusted hazard ratio, 1.50; 1.09-2.07) and a diagnosis of urinary incontinence at the time of pessary fitting (adjusted hazard ratio, 1.20; 0.62-0.99). Factors associated with a lower hazard of surgery included age (adjusted hazard ratio, 0.96 per year; 95% confidence interval, 0.95-0.97), dual Medicare/Medicaid eligibility (adjusted hazard ratio, 0.75; 95% confidence interval, 0.56-1.00), and pessary fitting by a nongynecologist (adjusted hazard ratio, 0.78; 95% confidence interval, 0.62-0.99). CONCLUSION: In this population of Medicare beneficiaries, within 7 years of pessary fitting, almost one-third of women aged >65 years underwent surgery for prolapse. These results add to our current understanding of the demographics of pessary use in an older population and may aid in counseling older patients presenting for treatment of symptomatic pelvic organ prolapse.

The RISE FOR HEALTH study: Methods for in-person assessment and biospecimen collection.

OBJECTIVES: To describe the methods for the in-person assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors that promote bladder health and/or prevent lower urinary tract symptoms in adult women, conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS AND RESULTS: A subset of RISE participants who express interest in the in-person assessment will be screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete 15 physical assessments in addition to height and weight, to assess pelvic floor muscle function, musculoskeletal (MSK) status, and pain, and to provide urogenital microbiome samples. Pelvic floor muscle assessments include presence of prolapse, strength, levator attachment integrity (tear) and myofascial pain. MSK tests evaluate core stability, lumbar spine, pelvic girdle and hip pain and function. Participants are asked to complete the Short Physical Performance Battery to measure balance, lower extremity strength, and functional capacity. All participants are asked to provide a voided urine sample and a vaginal swab for microbiome analyses; a subset of 100 are asked to contribute additional samples for feasibility and validation of a home collection of urinary, vaginal, and fecal biospecimens. RESULTS: Online and in-person training sessions were used to certify research staff at each clinical center before the start of RISE in-person assessments. Standardized protocols and data collection methods are employed uniformly across sites. CONCLUSIONS: The RISE in-person assessment is an integral portion of the overall population-based RISE study and represents an innovative approach to assessing factors hypothesized to promote bladder health and/or prevent lower urinary tract symptoms. Data collected from this assessment will be used to prioritize future research questions and prevention strategies and interventions. This description of the assessment methods is intended to provide methodologic transparency and inform other researchers who join efforts to understand and improve bladder health.

The RISE FOR HEALTH study: Methods for in-person musculoskeletal assessment.

OBJECTIVES: To describe the methods for the in-person musculoskeletal (MSK) assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors associated with bladder health (BH) conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS: A subset of RISE participants who express interest in the in-person assessment are screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete a standardized MSK assessment to evaluate core stability (four component core stability test, lumbar spine pain (seated slump test), pelvic girdle pain, (sacroiliac joint, anterior superior iliac spine, pubic symphysis tenderness, and pelvic girdle pain provocation test), hip pain (flexion, abduction, internal rotation and flexion, adduction and external rotation) and pelvic girdle function (active straight leg raise). Participants are also asked to complete the Short Physical Performance Battery to measure balance, gait speed, lower extremity strength, and functional capacity. RESULTS: Detailed online and in-person MSK training sessions led by physical therapy were used to certify research staff at each clinical center before the start of RISE in-person assessments. All evaluators exceeded the pre-specified pass rates. CONCLUSIONS: The RISE in-person MSK assessment will provide further insight into the role of general body MSK health and dysfunction and the spectrum of BH.

Incidence of urosepsis or pyelonephritis after uncomplicated urinary tract infection in older women.

INTRODUCTION AND HYPOTHESIS: Our primary aim was to describe the incidence of the diagnosis of urosepsis or pyelonephritis during the 60 days following initial evaluation of an uncomplicated urinary tract infection (UTI) among female Medicare beneficiaries ≥ 65 years of age. STUDY DESIGN: This was a retrospective cohort study of women ≥ 65 years of age undergoing evaluation for an incident, uncomplicated urinary tract infection (UTI) between the years 2011-2018 included in the Medicare 5% Limited Data Set (LDS). We grouped women into age categories of 65-74 years, 75-84 years, or > 84 years old. We excluded women with possible complicated UTI, those hospitalized within 60 days prior to index UTI evaluation, and those residing in a nursing home and place of service consistent with an inpatient setting/facility. The association between age and risk of each outcome was estimated with Cox proportional hazards models, controlling for relevant comorbidities. RESULTS: Between 2011-2018, 169,958 women met our inclusion/exclusion criteria and were evaluated for uncomplicated UTI. In total, 2935 (1.7%) had a subsequent diagnosis of either urosepsis (n = 2848, 1.6%) or pyelonephritis (n = 145, 0.08%). In adjusted analysis, the hazard of urosepsis was significantly higher for women > 84 years (aHR 1.49, 95% CI 1.38, 1.65; p < 0.01) and those aged 75-84 (aHR 1.24, 95% CI 1.13, 1.37; p < 0.01) compared to those aged 65-74 years. In contrast, age group was not significantly associated with the hazard for pyelonephritis. CONCLUSIONS: Urosepsis and pyelonephritis are very uncommon after evaluation of incident uncomplicated UTI in female medical beneficiaries ≥ 65 years of age.

International Urogynaecology Consultation chapter 1 committee 4: patients' perception of disease burden of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This manuscript from Chapter 1 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reports on the patients' perception of disease burden associated with pelvic organ prolapse. MATERIALS AND METHODS: An international group containing a team of eight urogynaecologists, a physiotherapist and a statistician performed a search of the literature using pre-specified search terms in PubMed and Embase (January 2000 to August 2020). The division of sections within this report includes: (1) perception of POP and the relationship with body image and poor health; (2) a vaginal bulge as it impacts health and wellbeing in women; (3) the impact of POP on sexual life; (4) body image and pelvic floor disorders; (5) POP and mood; (6) appropriate use of treatment goals to better meet patients' expected benefits; (7) using health-related quality of life questionnaires to quantify patients' perception of POP; (8) The financial burden of POP to patients and society. Abstracts were reviewed and publications were eliminated if not relevant or did not include populations with POP or were not relevant to the subject areas as noted by the authors. The manuscripts were next reviewed for suitability using the Specialist Unit for Review Evidence (SURE) checklists for cohort, cross-sectional and case-control epidemiologic studies. RESULTS: The original individual literature searches yielded 2312 references of which 190 were used in the final manuscript. The following perceptions were identified: (1) women were found to have varying perceptions of POP including shame and embarrassment. Some regard POP as consequence of aging and consider there is no effective therapy. (2) POP is perceived as a vaginal bulge and affects lifestyle and emotional wellbeing. The main driver for treatment is absence of bulge sensation. (3) POP is known to affect frequency of sexual intercourse but has less impact on satisfaction. (4) Prolapse-specific body image and genital self-image are important components of a women's emotional, physical and sexual wellbeing. (5) POP is commonly associated with depression and anxiety symptoms which impact HRQoL although are not correlated with objective anatomical findings. (6) Patient-centered treatment goals are useful in facilitating communication, shared decision-making and expectations before and after reconstructive surgery. (7) Disease-specific HRQoL questionnaires are important tools to assess bother and outcome following surgery, and there are now several tools with Level 1 evidence and a Grade A recommendation. (8) The cost of POP to the individual and to society is considerable in terms of productivity. In general, conservative measures tend to be more cost-effective than surgical intervention. CONCLUSIONS: Patients' perception of POP varies in different patients and has a far-reaching impact on their overall state of health and wellbeing. However, recognizing that it is a combination of body image and overall health (which affects mental health) allows clinicians to better tailor expectations for treatment to individual patients. There are HRQoL tools that can be used to quantify these impacts in clinical care and research. The costs to the individual patient (which affects their perception of POP) is an area that is poorly understood and needs more research.

Assessment of the Pelvic Floor and Associated Musculoskeletal System: Guide for Medical Practitioners.

OBJECTIVES: This study aimed to assist practitioners in performing an accurate assessment of the external and internal pelvic musculoskeletal (MSK) systems to improve appropriate diagnosis and referral of patients with pelvic floor disorders or pelvic pain and to improve understanding of physical therapy (PT) treatment principles, thereby improving communication between practitioners and encouraging a multidisciplinary approach. METHODS: A referenced review of the anatomy of the pelvic floor muscles, pelvis, and surrounding structures, followed by a detailed assessment of anatomy, posture, and gait, is presented. A thorough description of PT assessment and treatment is included with clinical relevance. RESULTS: When proper assessments are routinely performed, MSK conditions can be recognized, allowing for prompt and appropriate referrals to PT. Assessment and treatment by qualified physical therapists are integral to pelvic health care. After efficient medical assessment, MSK dysfunction can be addressed expeditiously, thereby avoiding further decline. Left unaddressed, pelvic dysfunction may become chronic. CONCLUSIONS: We propose a guide for MSK assessment of the pelvis and associated structures that can be used for both clinical and research purposes. This guide is designed for health care providers caring for women with pelvic floor disorders, including physicians, advanced practice providers, and nurses. This guide serves to improve communication among multidisciplinary practitioners to refine MSK assessment and treatment approaches and thereby advance clinical care and research.

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.

Development of Conceptual Models to Guide Public Health Research, Practice, and Policy: Synthesizing Traditional and Contemporary Paradigms.

This applied paper is intended to serve as a "how to" guide for public health researchers, practitioners, and policy makers who are interested in building conceptual models to convey their ideas to diverse audiences. Conceptual models can provide a visual representation of specific research questions. They also can show key components of programs, practices, and policies designed to promote health. Conceptual models may provide improved guidance for prevention and intervention efforts if they are based on frameworks that integrate social ecological and biological influences on health and incorporate health equity and social justice principles. To enhance understanding and utilization of this guide, we provide examples of conceptual models developed by the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. PLUS is a transdisciplinary U.S. scientific network established by the National Institutes of Health in 2015 to promote bladder health and prevent lower urinary tract symptoms, an emerging public health and prevention priority. The PLUS Research Consortium is developing conceptual models to guide its prevention research agenda. Research findings may in turn influence future public health practices and policies. This guide can assist others in framing diverse public health and prevention science issues in innovative, potentially transformative ways.

Racial/Ethnic Disparities/Differences in Hysterectomy Route in Women Likely Eligible for Minimally Invasive Surgery.

STUDY OBJECTIVE: Evaluate racial/ethnic variation in hysterectomy surgical route in women likely eligible for minimally invasive hysterectomy. DESIGN: Cross-sectional study. SETTING: Multistate including Colorado, Florida, Maryland, New Jersey, and New York. PATIENTS: Women aged ≥18 years without diagnoses of leiomyomas, obesity, or previous abdominopelvic surgery who underwent hysterectomy for benign conditions from the State Inpatient and Ambulatory Surgery Databases, 2010-2014. INTERVENTIONS: None. Primary exposure is race/ethnicity. MEASUREMENTS AND MAIN RESULTS: Racial/ethnic variation in annual hysterectomy rates and surgical route. To calculate hysterectomy rates per 100 000 women/year, denominators were adjusted for the proportion of women with previous hysterectomy. A marginal structural log binomial regression model was used to estimate adjusted standardized prevalence ratios (aPRs) for vaginal or laparoscopic vs abdominal hysterectomy, controlling for clustering within hospitals. In addition, hospitals were stratified into quintiles to examine surgical route in hospitals that serve a higher vs lower proportion of African American patients. A total of 133 082 adult women underwent hysterectomy for benign conditions from 2010 to 2014. Annual laparoscopic rates increased more slowly for African Americans (1.6-fold) than for whites (1.8-fold) and Hispanics (1.9-fold). African American and Hispanic women were less likely to undergo vaginal (aPR = 0.93; 95% confidence interval [CI], 0.90-0.96 and aPR = 0.95; 95% CI 0.93-0.97, respectively) and laparoscopic hysterectomy (aPR = 0.90; 95% CI, 0.87-0.94 and aPR = 0.95; 95% CI, 0.92-0.98, respectively) than white women; Asian/Pacific Islander women were less likely to undergo vaginal hysterectomy (aPR = 0.88; 95% CI, 0.81-0.96). Hospitals serving a higher proportion of African American persons performed more abdominal and fewer vaginal procedures across all groups, and more racial/ethnic minority women sought care at those hospitals than white women. CONCLUSION: African American, Hispanic, and Asian/Pacific Islander women eligible for minimally invasive hysterectomy were more likely than white women to receive abdominal hysterectomy. The proportion of all women undergoing abdominal hysterectomy was highest at hospitals serving higher proportions of African American persons. This difference in treatment type can lead to disparities in outcomes, in part owing to their association with complications.

Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain.

BACKGROUND: Pelvic floor myofascial pain is common, but physical examination methods to assess pelvic floor muscles are defined poorly. We hypothesized that a simple, transvaginal pelvic floor examination could be developed that would be highly reproducible among providers and would adequately screen for the presence of pelvic floor myofascial pain. OBJECTIVE: The purpose of this study was to develop a simple, reproducible pelvic floor examination to screen for pelvic floor myofascial pain. STUDY DESIGN: A screening examination was developed by Female Pelvic Medicine & Reconstructive Surgery subspecialists and women's health physical therapists at our institution and tested in a simulated patient. We recruited 35 new patients who underwent examinations by blinded, paired, independent examiners. Agreement was calculated with the use of percent agreement and Spearman's rank correlation coefficient. RESULTS: The final examination protocol begins with examination of the following external sites: bilateral sacroiliac joints, medial edge of the anterior superior iliac spine, and cephalad edge of the pubic symphysis (self-reported pain: yes/no). The internal examination follows with palpation of each muscle group in the center of the muscle belly, then along the length of the muscle proceeding counter-clockwise: right obturator internus, right levator ani, left levator ani, left obturator internus (pain on a scale of 0-10). Thirty-five patients were enrolled. Correlation was high at each external (0.80-0.89) and internal point (0.63-0.87; P<.0001). CONCLUSION: Our newly developed, standardized, reproducible examination incorporates assessment of internal and external points to screen for pelvic floor myofascial pain. The examination is straightforward and reproducible and allows for easy use in clinical practice.

Physical examination techniques for the assessment of pelvic floor myofascial pain: a systematic review.

BACKGROUND: Myofascial pain is characterized by the presence of trigger points, tenderness to palpation, and local or referred pain, and commonly involves the pelvic floor muscles in men and women. Pelvic floor myofascial pain in the absence of local or referred pain has also been observed in patients with lower urinary tract symptoms, and we have found that many patients report an improvement in these symptoms after receiving myofascial-targeted pelvic floor physical therapy. OBJECTIVE: We sought to systematically review the literature for examination techniques used to assess pelvic floor myofascial pain in women. STUDY DESIGN: We performed a systematic literature search using strategies for the concepts of pelvic floor disorders, myofascial pain, and diagnosis in Ovid MEDLINE 1946-, Embase 1947-, Scopus 1960-, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Cochrane Database of Systematic Reviews. Articles were screened by 3 authors and included if they contained a description of a pelvic myofascial physical examination. RESULTS: In all, 55 studies met our inclusion criteria. Overall, examination components varied significantly among the included studies and were frequently undefined. A consensus examination guideline was developed based on the available data and includes use of a single digit (62%, 34/55) to perform transvaginal palpation (75%, 41/55) of the levator ani (87%, 48/55) and obturator internus (45%, 25/55) muscles with a patient-reported scale to assess the level of pain to palpation (51%, 28/55). CONCLUSION: Physical examination methods to evaluate pelvic musculature for presence of myofascial pain varied significantly and were often undefined. Given the known role of pelvic floor myofascial pain in chronic pelvic pain and link between pelvic floor myofascial pain and lower urinary tract symptoms, physicians should be trained to evaluate for pelvic floor myofascial pain as part of their physical examination in patients presenting with these symptoms. Therefore, the development and standardization of a reliable and reproducible examination is needed.

A Novel Research Definition of Bladder Health in Women and Girls: Implications for Research and Public Health Promotion.

BACKGROUND: Bladder health in women and girls is poorly understood, in part, due to absence of a definition for clinical or research purposes. This article describes the process used by a National Institutes of Health funded transdisciplinary research team (The Prevention of Lower Urinary Tract Symptoms [PLUS] Consortium) to develop a definition of bladder health. METHODS: The PLUS Consortium identified currently accepted lower urinary tract symptoms (LUTS) and outlined elements of storage and emptying functions of the bladder. Consistent with the World Health Organization's definition of health, PLUS concluded that absence of LUTS was insufficient and emphasizes the bladder's ability to adapt to short-term physical, psychosocial, and environmental challenges for the final definition. Definitions for subjective experiences and objective measures of bladder dysfunction and health were drafted. An additional bioregulatory function to protect against infection, neoplasia, chemical, or biologic threats was proposed. RESULTS: PLUS proposes that bladder health be defined as: "A complete state of physical, mental, and social well-being related to bladder function and not merely the absence of LUTS. Healthy bladder function permits daily activities, adapts to short-term physical or environmental stressors, and allows optimal well-being (e.g., travel, exercise, social, occupational, or other activities)." Definitions for each element of bladder function are reported with suggested subjective and objective measures. CONCLUSIONS: PLUS used a comprehensive transdisciplinary process to develop a bladder health definition. This will inform instrument development for evaluation of bladder health promotion and prevention of LUTS in research and public health initiatives.

Apical Vaginal Support: The Often Forgotten Piece of the Puzzle.

Pelvic organ prolapse is common among women who have delivered vaginally or had a hysterectomy. In a total hysterectomy, the apical vaginal support is transected. Although evidence supports re-establishment of apical support, our research showed that this rarely occurs in hysterectomies. To address our lack of definitions of "significant" apical support loss and recommendations to guide surgeons as to when they should perform an apical support procedure, we analyzed patient data and found that a simple assessment of the genital hiatus can effectively screen for significant apical support loss. Our work will hopefully highlight the importance of apical support loss and current deficits in research and clinical guidelines.

Should endocervical curettage routinely be performed at the time of colposcopy? A cost-effectiveness analysis.

OBJECTIVES: Endocervical curettage (ECC) has been used with colposcopy-directed biopsy to increase diagnostic sensitivity for detecting cellular abnormality. Our objective was to determine if routine ECC was cost-effective compared with colposcopy alone in women with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion cervical cytology, who are older and younger than 50 years. MATERIALS AND METHODS: We generated a cost-effectiveness model using outcomes from cervical screening including repeat Pap smears, colposcopy, and loop electrosurgical excision procedure. Cervical cancer costs, survival, as well as incidence and complications after loop electrosurgical excision procedure (preterm birth, cervical stenosis, dysmenorrhea, amenorrhea, and infertility) were modeled. Cost and probability values were obtained from published literature and Medicare databases. Direct medical costs were analyzed in 2011 US dollars. Effectiveness outcomes were cervical cancer deaths and incident cases of cancer prevented. Model robustness was evaluated using probabilistic sensitivity analysis. RESULTS: For women older than 50 years, routine ECC is the dominant strategy (less expensive and more effective at reducing cervical cancer deaths/incidence). For women younger than 50 years, routine ECC costs $96,737 more per cervical cancer death prevented. Cost per incident cancer case prevented ranged from $21,894 (local spread or greater) to $235,873 (distal spread). Sensitivity analysis confirmed these conclusions. In women older than 50 years, routine ECC was always the most likely cost-effective choice. In women younger than 50, routine ECC was most likely cost-effective for all willingness-to-pay thresholds greater than $80,000 to prevent 1 cancer death. CONCLUSIONS: In women older than 50 years, routine ECC is favored over colposcopy alone because this strategy is cost saving and reduces the number of cancer deaths and incident cancer cases. For women younger than 50 years, cost-effectiveness is dependent on willingness to pay to prevent 1 cancer death but still seems to be cost-effective.

Managing mesh exposure following vaginal prolapse repair: a decision analysis comparing conservative versus surgical treatment.

INTRODUCTION AND HYPOTHESIS: A decision analysis model was developed comparing conservative and surgical treatments in the management of synthetic mesh exposure following vaginal prolapse repair. We hypothesized that surgical excision would be favored. METHODS: A Markov decision analysis model compared initial management with conservative versus surgical treatment allowing for the complexities of multiple attempts at conservative management and/or surgical mesh excision. Model assumptions were obtained from published literature or through surrogate values and expert consensus when not available in published resources. Transitions were made between Markov states at 6-week intervals and overall utility was compared over 2 years. Multiple one-way sensitivity analyses were performed. RESULTS: Initial surgical excision was favored, with an average yearly quality adjusted life year (QALY) value of 0.947 compared to 0.939 for conservative treatment. This difference is less than the published minimally important difference (MID) for utility values. One-way sensitivity analyses revealed that surgical excision is favored when the probability of being healed with conservative therapy is less than 80 % (base case 57.1 %) and when the probability of being healed from surgery is greater than 78 % (base case 93.2 %). Few thresholds confirmed model robustness. CONCLUSIONS: While our model favored surgical excision over conservative treatment in the initial management of mesh exposure following vaginal prolapse repair with synthetic mesh, the difference in QALYs between strategies was less than the MID. Therefore the strategies are likely similar overall. Individual patient characteristics may ultimately drive clinical decision-making for this surgical complication.

Midurethral sling for treatment of occult stress urinary incontinence at the time of colpocleisis: a decision analysis.

OBJECTIVE: The objective of this study was to estimate optimal timing for treatment of occult stress urinary incontinence in women undergoing colpocleisis using decision analysis methodology. METHODS: A decision tree was constructed comparing concomitant versus staged midurethral slings (MUSs). Simple roll-back methodology was used to determine average 1-year utilities of the compared approaches. RESULTS: One-year overall utility favored the staged approach to treating occult incontinence (0.945 vs 0.908) at time of colpocleisis. However, this difference was less than the accepted minimally important difference for utilities. Multiple 1-way sensitivity analyses of all utilities and probabilities identified few thresholds, confirming model robustness. In our model, only 22.5% of women in the staged group ultimately underwent MUS. CONCLUSIONS: Staged and concomitant MUSs have similar overall utilities. Both strategies are clinically reasonable, and surgical decision making should be tailored to individual patient needs and preferences. In our model, a staged approach greatly reduces the number of MUS performed.

InterStim Sacral Neuromodulation and Botox Botulinum-A Toxin Intradetrusor Injections for Refractory Urge Urinary Incontinence: A Decision Analysis Comparing Outcomes Including Efficacy and Complications.

OBJECTIVE: : Overactive bladder is a common disease for which current pharmaceutical therapy is often unsatisfactory. Newer modalities, including Botox and InterStim, can be used when antimuscarinics fail. We compare InterStim and Botox using decision analysis. METHODS: : A Markov state transition decision analysis model was constructed using values for efficacy and complications from the literature. Overall utility was compared monthly. Multiple 1-way sensitivity analyses were performed. RESULTS: : For every month during the simulation, overall utility was higher for Botox than InterStim. After 54 months, cumulative utility was 3.86 versus 3.74, favoring Botox for an average yearly quality-adjusted life-year value of 0.86 versus 0.83. All differences were less than minimally important differences for utilities. Few meaningful thresholds were established supporting the robustness of the model. CONCLUSIONS: : Until appropriately powered randomized controlled trials are available, both InterStim and Botox are reasonable and effective strategies with similar outcomes.

Retropubic and transobturator midurethral slings: a decision analysis to compare outcomes including efficacy and complications.

INTRODUCTION AND HYPOTHESIS: The objective of this paper is to compare retropubic (RP) and transobturator (TO) midurethral slings using decision analysis techniques. METHODS: A decision analysis was constructed including efficacy and complication data. Probability of complication-free surgery and overall utility were analyzed using two models: ALL (all 42 trials) and RCT (seven randomized controlled trials with higher quality data, but missing data on some complications). RESULTS: Surgery was complication-free more frequently with TO approach with 83.7% vs. 55.7% (ALL) and 70.9% vs. 62.8% (RCT). One-year overall utility favored TO in the ALL model (0.943 vs. 0.895). Conversely, the RCT model favored RP (0.936 vs. 0.910). These differences were both less than published minimally important differences (MID) for utilities. Multiple one-way sensitivity analyses confirmed robustness of results. CONCLUSIONS: The difference between the two surgeries in both utility-based models was less than the MID. Therefore, the separate approaches are highly comparable with similar overall utility. Complications are more frequent with the retropubic approach.