Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

BACKGROUND: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. OBJECTIVE: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY DESIGN: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile. RESULTS: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years. CONCLUSION: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting.

BACKGROUND: Physicians and hospital systems often have relationships with biomedical manufacturers to develop new ideas, products, and further education. Because this relationship can influence medical research and practice, reporting disclosures are necessary to reveal any potential bias and inform consumers. The Sunshine Act was created to develop a new reporting system of these financial relationships called the Open Payments database. Currently all disclosures submitted with research to scientific meetings are at the discretion of the physician. We hypothesized that financial relationships between authors and the medical industry are underreported. OBJECTIVES: We aimed to describe concordance between physicians' financial disclosures listed in the abstract book from the 41st annual scientific meeting of the Society of Gynecologic Surgeons to physician payments reported to the Center for Medicaid and Medicare Services Open Payments database for the same year. STUDY DESIGN: Authors and scientific committee members responsible for the content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons were identified from the published abstract book; each abstract listed disclosures for each author. Abstract disclosures were compared with the transactions recorded on the Center for Medicaid and Medicare Services Open Payments database for concordance. Two authors reviewed each nondisclosed Center for Medicaid and Medicare Services listing to determine the relatedness between the company listed on the Center for Medicaid and Medicare Services and abstract content. RESULTS: Abstracts and disclosures of 335 physicians meeting inclusion criteria were reviewed. A total of 209 of 335 physicians (62%) had transactions reported in the Center for Medicaid and Medicare Services, which totaled $1.99 million. Twenty-four of 335 physicians (7%) listed companies with their abstracts; 5 of those 24 physicians were concordant with the Center for Medicaid and Medicare Services. The total amount of all nondisclosed transactions was $1.3 million. Transactions reported in the Center for Medicaid and Medicare Services associated with a single physician ranged from $11.72 to $405,903.36. Of the 209 physicians with Center for Medicaid and Medicare Services transactions that were not disclosed, the majority (68%) had at least 1 company listed in the Center for Medicaid and Medicare Services that was determined after review to be related to the subject of their abstract. CONCLUSION: Voluntary disclosure of financial relationships was poor, and the majority of unlisted disclosures in the abstract book were companies related to the scientific content of the abstract. Better transparency is needed by physicians responsible for the content presented at gynecological scientific meetings.

Elder American Indian women's knowledge of pelvic floor disorders and barriers to seeking care.

OBJECTIVES: The objectives of this study are to evaluate urinary incontinence and pelvic organ prolapse knowledge among elder southwestern American Indian women and to assess barriers to care for pelvic floor disorders through community-engaged research. METHODS: Our group was invited to provide an educational talk on urinary incontinence and pelvic organ prolapse at an annual meeting of American Indian elders. Female attendees aged 55 years or older anonymously completed demographic information and 2 validated questionnaires, the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) and Barriers to Incontinence Care Seeking Questionnaire (BICS-Q). Questionnaire results were compared with historical controls from the original PIKQ and BICS-Q validation study. RESULTS: One hundred forty-four women completed the questionnaires. The mean age was 77.7 ± 9.1 years. The mean (SD) for PIKQ of urinary incontinence score was 6.6 (3.0) (similar to historic gynecology controls 6.8 [3.3], P = 0.49), and the mean (SD) for PIKQ on pelvic organ prolapse score was 5.4 (2.9) (better than historic gynecology controls 3.6 [3.2], P < 0.01). Barriers to care seeking reported by the elder women were highest on the BICS-Q subscales of "cost" and "inconvenience." CONCLUSIONS: Urinary incontinence knowledge is similar to historic gynecology controls, and pelvic organ prolapse knowledge is higher than historic gynecology controls among elder southwestern American Indian women. American Indian elder women report high levels of barriers to care. The greatest barriers to care seeking for this population were related to cost and inconvenience, reflecting the importance of assessing socioeconomic status when investigating barriers to care. Addressing these barriers may enhance care-seeking southwestern American Indian women.

The Association Between Distances Traveled for Care and Treatment Choices for Pelvic Floor Disorders in a Rural Southwestern Population.

OBJECTIVES: To determine if distance traveled for care influenced patient choice for conservative vs. surgical treatment for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). METHODS: Retrospective chart review of all new patients seen in the Urogynecology clinic at the University of New Mexico Hospital (UNMH) from January 2007 through September 2011. Data collected included medical history, Pelvic Organ Prolapse Quantification (POPQ) examination, and validated quality of life questionnaires. RESULTS: 1384 women were identified with POP and/or SUI. Women traveled an average of 50 miles to receive care at UNMH. After multivariable analysis, greater distance traveled was associated with increased likelihood of choosing surgery, OR 1.45 [1.18-1.76]. More advanced disease as measured by higher stage of prolapse, OR 3.43 [2.30-5.11], and positive leak with empty supine cough test, OR 1.94 [1.45-2.59] were also associated with choosing surgical management. CONCLUSIONS: Women who travel further for care and women with more advanced pelvic organ prolapse and/or stress urinary incontinence are more likely to choose surgical management for pelvic floor disorders.

Fecal incontinence in primary care: prevalence, diagnosis, and health care utilization.

OBJECTIVE: We sought to estimate the frequency of self-reported fecal incontinence (FI), identify what proportion of these patients have a diagnosis of FI in their medical record, and compare health care costs and utilization in patients with different severities of FI to those without FI. STUDY DESIGN: Patients in a health maintenance organization were eligible and 1707 completed a survey. Patients with self-reported FI were assessed for a diagnosis of FI in their medical record for the last 5 years. Health care costs and utilization were obtained from claims data. RESULTS: FI was reported by 36.2% of primary care patients, but only 2.7% of patients with FI had a medical diagnosis. FI adversely affected quality of life and severe FI was associated with 55% higher health care costs (including 77% higher gastrointestinal-related health care costs) compared to continent patients. CONCLUSION: Increased screening of FI is needed.