Cost-effectiveness of prophylactic retropubic sling at the time of vaginal prolapse surgery.

BACKGROUND: Prophylactic midurethral sling placement at the time of prolapse repair significantly reduces the risk for de novo stress urinary incontinence, but it is associated with some small but significant morbidities. Because there has not been a standardized approach to midurethral sling utilization, decision analysis provides a method to evaluate the cost and effectiveness associated with varying midurethral sling placement strategies in addressing the risk for de novo stress urinary incontinence. OBJECTIVE: We aimed to compare the cost effectiveness of the 3 midurethral sling utilization strategies in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. The 3 approaches are (1) staged strategy in which prolapse repair is done without prophylactic midurethral sling placement, (2) universal sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement, and (3) selective sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement only in patients with a positive prolapse-reduced cough stress test. STUDY DESIGN: We created a decision analysis model to compare staged strategy, universal sling placement, and selective sling placement. We modeled probabilities of de novo stress urinary incontinence, patients choosing subsequent midurethral sling surgery for de novo stress urinary incontinence, and outcomes related to midurethral sling placement. De novo stress urinary incontinence rates were determined for each strategy from published data. The likelihood of patients with de novo stress urinary incontinence choosing midurethral sling surgery as their first-line treatment was also determined from the literature, and this scenario was only applied to patients without prophylactic midurethral sling placement at their index prolapse repair. Finally, outcomes related to midurethral sling placement, including recurrent or persistent stress urinary incontinence, voiding dysfunction requiring sling lysis, mesh exposure requiring excision, and de novo overactive bladder requiring medications, were all derived from publicly available data. All midurethral sling placement procedures were assumed to be retropubic. The costs for each procedure were obtained from the 2020 Centers for Medicare & Medicaid Services Physician Fee Schedule or from previous literature with convertion to 2020 equivalent US dollar prices using the Consumer Price Index. The primary outcome was modeled as the incremental cost-effectiveness ratio. We performed multiple 1-way sensitivity analyses to assess model robustness. RESULTS: The lowest-cost strategy was the staged strategy, which cost $1051.70 per patient, followed by $1093.75 for selective sling placement and $1125.54 for universal sling placement. The selective sling approach, however, had the highest health utility value; therefore, universal sling placement was dominated by selective sling placement because it is both less costly and more effective. When compared with the staged strategy, selective sling placement was cost effective with an incremental cost-effectiveness ratio of $2664 per quality adjusted life-years, meeting the predetermined threshold. In multiple 1-way sensitivity analyses, the variable with the largest effect was the percentage of patients electing to undergo subsequent midurethral sling surgery for de novo stress urinary incontinence after the index surgery. Only when this proportion exceeded 62% did universal sling placement become the cost-effective option because selective sling placement surpassed the predetermined incremental cost-effectiveness ratio threshold and became dominated. CONCLUSION: Selective sling placement was the preferred and cost-effective strategy in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. Surgeons should counsel their patients preoperatively regarding the possibility of de novo stress urinary incontinence after prolapse repair, as well as on the benefits and risks of prophylactic midurethral sling placement surgery.

Salpingo-oophorectomy or surveillance for ovarian endometrioma in asymptomatic premenopausal women: a cost-effectiveness analysis.

BACKGROUND: The lifetime risk of ovarian cancer is 1.9% among women with endometriosis compared with 1.3% among the general population. When an asymptomatic endometrioma is incidentally discovered on imaging, gynecologists must weigh the procedural complications and the potential for subsequent surgical menopause against future ovarian pathology or cancer. OBJECTIVE: We aimed to determine if performing unilateral salpingo-oophorectomy is a more cost-effective strategy for the prevention of death than surveillance for asymptomatic endometriomas. STUDY DESIGN: We created a cost-effectiveness model using TreeAge Pro (TreeAge Software Inc; Williamstown, MA) with a lifetime horizon. Our hypothetical cohort included premenopausal patients with 2 ovaries who did not desire fertility. Those diagnosed with asymptomatic endometrioma underwent either unilateral salpingo-oophorectomy or surveillance (ultrasound 6-12 weeks after diagnosis, then annually). Our primary effectiveness outcome was mortality, including death from ovarian cancer or surgery and all-cause mortality related to surgical menopause (± hormone replacement therapy) if the contralateral ovary is removed. We modeled the probabilities of surgical complications, occult malignancy, development of contralateral adnexal pathology, surgical menopause, use of hormone replacement therapy, and development of ovarian cancer. The costs included surgical procedures, complications, ultrasound surveillance, hormone therapy, and treatment of ovarian cancer, with information gathered from Medicare reimbursement data and published literature. Cost-effectiveness was determined using the incremental cost-effectiveness ratio of Δ costs / Δ deaths with a willingness-to-pay threshold of $11.6 million as the value of a statistical life. Multiple 1-way sensitivity analyses were performed to evaluate model robustness. RESULTS: Our model demonstrated that unilateral salpingo-oophorectomy is associated with improved outcomes compared with surveillance, with fewer deaths (0.28% vs 1.50%) and fewer cases of ovarian cancer (0.42% vs 2.96%). However, it costs more than sonographic surveillance at $6403.43 vs $5381.39 per case of incidental endometrioma. The incremental cost-effectiveness ratio showed that unilateral salpingo-oophorectomy costs $83,773.77 per death prevented and $40,237.80 per case of ovarian cancer prevented. As both values were well below the willingness-to-pay threshold, unilateral salpingo-oophorectomy is cost-effective and is the preferred strategy. If unilateral salpingo-oophorectomy were chosen over surveillance for premenopausal patients with incidental endometriomas, 1 diagnosis of ovarian cancer would be prevented in every 40 patients and 1 death averted in every 82 patients. We performed 1-way sensitivity analyses for all input variables and determined that there were no reasonable inputs that would alter our conclusions. CONCLUSION: Unilateral salpingo-oophorectomy is cost-effective and is the preferred strategy compared with surveillance for the management of incidental endometrioma in a premenopausal patient not desiring fertility. It incurs fewer deaths and fewer cases of ovarian cancer with costs below the national willingness-to-pay thresholds.

Mortality and Reoperation Following Midurethral Sling Versus Urethral Bulking in Older Women.

OBJECTIVE: To examine differences in mortality, retreatment rates, and comorbidities that may be risk factors for retreatment among Medicare beneficiaries (age 65+) undergoing midurethral sling vs urethral bulking. MATERIALS AND METHODS: This was a retrospective cohort study using the 5% limited data set from the Center for Medicare and Medicaid Services between 2010 and 2018. Beneficiaries age 65 or older who underwent sling or bulking without concomitant surgery from 2011 to 2014 were included and followed until reoperation or retreatment, loss of Medicare, death, or December 31, 2018. Repeat procedures for ongoing stress incontinence or complication were included. Associations between index treatment and need for a secondary procedure were evaluated using Cox proportional hazards models. RESULTS: Median follow-up time was 5.7 years for 1,700 patients undergoing sling and 5.2 years for 875 patients undergoing bulking. Within 5 years, 10.2% of sling patients and 23.2% of bulking patients had died. When controlling for age, race, and comorbidities, bulking patients were 1.73 times more likely than sling patients to die during the study period. Bulking patients were significantly more likely to have 12 of the 16 of the medical comorbidities evaluated. By 5 years, 6.7% of sling patients had been retreated for stress urinary incontinence (SUI) compared with 24.6% of bulking patients. Apart from hypertension, none of the comorbidities evaluated was associated with a difference in the risk of a subsequent surgical procedure. Members of racial and ethnic minority groups were less likely to be retreated. CONCLUSION: Older adults undergoing bulking are notably sicker and have shorter life expectancy as compared with those undergoing sling, suggesting these factors heavily guide patient selection. Comorbidities do not predispose patients to reoperation or retreatment.

Hysterectomy Versus Hysteropexy at the Time of Native Tissue Pelvic Organ Prolapse Repair: A Cost-Effectiveness Analysis.

OBJECTIVE: The aim of the study was to determine whether a hysterectomy at the time of native tissue pelvic organ prolapse repair is cost-effective for the prevention of endometrial cancer. METHODS: We created a decision analysis model using TreeAge Pro. We modeled prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension (TVH-USLS) versus sacrospinous ligament fixation hysteropexy (SSLF-HPXY). We modeled incidence and diagnostic evaluation of postmenopausal bleeding, including risk of endometrial pathology and diagnosis or death from endometrial cancer. Modeled costs included those associated with the index procedure, subsequent prolapse repair, endometrial biopsy, pelvic ultrasound, hysteroscopy, dilation and curettage, and treatment of endometrial cancer. RESULTS: TVH-USLS costs US $587.61 more than SSLF-HPXY per case of prolapse. TVH-USLS prevents 1.1% of women from experiencing postmenopausal bleeding and its diagnostic workup. It prevents 0.95% of women from undergoing subsequent major surgery for the treatment of either prolapse recurrence or suspected endometrial cancer. Using our model, it costs US $2,698,677 to prevent one cancer death by performing TVH-USLS. As this is lower than the value of a statistical life, it is cost-effective to perform TVH-USLS for cancer prevention. Multiple 1-way sensitivity analyses showed that changes to input variables would not significantly change outcomes. CONCLUSIONS: TVH-USLS increased costs but reduced postmenopausal bleeding and subsequent major surgery compared with SSLF-HPXY. Accounting for these differences, TVH-USLS was a cost-effective approach for the prevention of endometrial cancer. Uterine preservation/removal at the time of prolapse repair should be based on the woman's history and treatment priorities, but cancer prevention should be one aspect of this decision.

Hysterectomy Volume Among Recent Obstetrics and Gynecology Residency Graduates.

OBJECTIVE: Although guidelines recommend hysterectomy be performed vaginally whenever possible, recent trainees have decreased exposure to vaginal hysterectomy given the availability of laparoscopic hysterectomy, nonsurgical management, and falling volume nationwide. We sought to estimate hysterectomy volume in the 5 years after residency. Our secondary objective was to compare vaginal hysterectomy utilization between recent graduates and senior surgeons. METHODS: Retrospective, statewide data from 2005 to 2014 was obtained from the Massachusetts Center for Health Information Analysis. All hysterectomies performed in Massachusetts, regardless of payer type, were included. Surgeon identifiers were cross-referenced to another data set with provider demographics. Hysterectomies performed in the first 5 years after graduation were compared with a group 21 to 25 years after residency. RESULTS: Data from inpatient and outpatient databases revealed 87,846 hysterectomies performed by 1967 physicians, including 3146 simple hysterectomies by 192 recent graduates. Recent graduates chose abdominal hysterectomy (44.2%) most commonly, followed by laparoscopic (29.4%), vaginal (16.1%), and laparoscopically assisted vaginal (10.4%). Recent graduates performed a median of 3 to 4 hysterectomies in each of the first 5 years with no increase over time (P = 1). The median number of vaginal or laparoscopic hysterectomies was 0 in these 5 years (interquartile ranges, 0-1 and 0-2, respectively). Members of the senior cohort performed a median of 8 to 9 hysterectomies annually, completing them vaginally more often (24.7% vs 16.1%, P < 0.01). When controlling for patient age and hysterectomy indication, this effect dissipated. CONCLUSIONS: Recent graduates perform 3 to 4 (interquartile range, 1-7) hysterectomies annually, predominantly by laparotomy. Although senior surgeons perform vaginal hysterectomy more often, this is explained by patient characteristics.

Cystoscopy at the time of benign hysterectomy: a decision analysis.

BACKGROUND: Gynecologists debate the optimal use for intraoperative cystoscopy at the time of benign hysterectomy. Although adding cystoscopy leads to additional up-front cost, it may also enable intraoperative detection of a urinary tract injury that may otherwise go unnoticed. Prompt injury detection and intraoperative repair decreases morbidity and is less costly than postoperative diagnosis and treatment. Because urinary tract injury is rare and not easily studied in a prospective fashion, decision analysis provides a method for evaluating the cost associated with varying strategies for use of cystoscopy. OBJECTIVE: The objective of the study was to quantify costs of routine cystoscopy, selective cystoscopy, or no cystoscopy with benign hysterectomy. STUDY DESIGN: We created a decision analysis model using TreeAge Pro. Separate models evaluated cystoscopy following abdominal, laparoscopic/robotic, and vaginal hysterectomy from the perspective of a third-party payer. We modeled bladder and ureteral injuries detected intraoperatively and postoperatively. Ureteral injury detection included false-positive and false-negative results. Potential costs included diagnostics (imaging, repeat cystoscopy) and treatment (office/emergency room visits, readmission, ureteral stenting, cystotomy closure, ureteral reimplantation). Our model included costs of peritonitis, urinoma, and vesicovaginal/ureterovaginal fistula. Complication rates were determined from published literature. Costs were gathered from Medicare reimbursement as well as published literature when procedure codes could not accurately capture additional length of stay or work-up related to complications. RESULTS: From prior studies, bladder injury incidence was 1.75%, 0.93%, and 2.91% for abdominal, laparoscopic/robotic, and vaginal hysterectomy, respectively. Ureteral injury incidence was 1.61%, 0.46%, and 0.46%, respectively. Hysterectomy costs without cystoscopy varied from $884.89 to $1121.91. Selective cystoscopy added $13.20-26.13 compared with no cystoscopy. Routine cystoscopy added $51.39-57.86 compared with selective cystoscopy. With the increasing risk of injury, selective cystoscopy becomes cost saving. When bladder injury exceeds 4.48-11.44% (based on surgical route) or ureteral injury exceeds 3.96-8.95%, selective cystoscopy costs less than no cystoscopy. Therefore, if surgeons estimate the risk of injury has exceeded these thresholds, cystoscopy may be cost saving. However, for routine cystoscopy to be cost saving, the risk of bladder injury would need to exceed 20.59-47.24% and ureteral injury 27.22-37.72%. Model robustness was checked with multiple 1-way sensitivity analyses, and no relevant thresholds for model variables other than injury rates were identified. CONCLUSION: While routine cystoscopy increased the cost $64.59-83.99, selective cystoscopy had lower increases ($13.20-26.13). These costs are reduced/eliminated with increasing risk of injury. Even a modest increase in suspicion for injury should prompt selective cystoscopy with benign hysterectomy.

Risks and benefits of opportunistic salpingectomy during vaginal hysterectomy: a decision analysis.

BACKGROUND: Fallopian tubes are commonly removed during laparoscopic and open hysterectomy to prevent ovarian and tubal cancer but are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training. OBJECTIVE: We sought to quantify complications and costs associated with a strategy of planned salpingectomy during vaginal hysterectomy. STUDY DESIGN: We created a decision analysis model using TreeAgePro. Effectiveness outcomes included ovarian cancer incidence and mortality as well as major surgical complications. Modeled complications included transfusion, conversion to laparotomy or laparoscopy, abscess/hematoma requiring intervention, ileus, readmission, and reoperation within 30 days. We also modeled subsequent benign adnexal surgery beyond the postoperative window. Those whose procedures were converted from a vaginal route were assumed to undergo bilateral salpingectomy, regardless of treatment group, following American College of Obstetricians and Gynecologists guidelines. Costs were gathered from published literature and Medicare reimbursement data, with internal cost data from 892 hysterectomies at a single institution used to estimate costs when necessary. Complication rates were determined from published literature and from 13,397 vaginal hysterectomies recorded in the National Surgical Quality Improvement Program database from 2008 through 2013. RESULTS: Switching from a policy of vaginal hysterectomy alone to a policy of routine planned salpingectomy prevents a diagnosis of ovarian cancer in 1 of every 225 women having surgery and prevents death from ovarian cancer in 1 of every 450 women having surgery. Overall, salpingectomy was a less expensive strategy than not performing salpingectomy ($7350.62 vs $8113.45). Sensitivity analysis demonstrated the driving force behind increased costs was the increased risk of subsequent benign adnexal surgery among women retaining their tubes. Planned opportunistic salpingectomy had more major complications than hysterectomy alone (7.95% vs 7.68%). Major complications included transfusion, conversion to laparotomy or laparoscopy, abscess/hematoma requiring intervention, ileus, readmission, and reoperation within 30 days. Therefore, routine salpingectomy results in 0.61 additional complications per case of cancer prevented and 1.21 additional complications per death prevented. A surgeon therefore must withstand an additional ∼3 complications to prevent 5 cancer diagnoses and ∼6 additional complications to prevent 5 cancer deaths. CONCLUSION: Salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.

Association between body mass index and pain following transobturator sling.

We aimed to prospectively evaluate the association between body mass index (BMI) and development of postoperative-onset pain in women undergoing transobturator midurethral sling procedures. We conducted a prospective, observational cohort study of women undergoing inside-to-out transobturator midurethral sling. At preoperative visit, height, weight, self-reported activity level and baseline pain were documented. At postoperative visits, patients indicated pain location and severity, procedure success, and satisfaction. We used log binomial regression to calculate risk ratios, controlling for potential confounders. For the 129 women included, median age was 50.0 years and BMI was 27.2 kg/m2. Adjusting for age and activity level, overweight and obese women had significantly increased risk of postoperative-onset pain compared to normal BMI women. Overweight women were at 1.70 (95%CI 1.05-2.75) times the risk compared to leaner counterparts, whereas obese women were at 1.76 times the risk (95%CI 1.04-2.89). Neither success nor satisfaction was associated with BMI. Impact statement Over three million midurethral slings have been placed worldwide for the treatment or prevention of stress urinary incontinence. The procedure has been studied in lean, overweight and obese populations, and found to have similar efficacy regardless of BMI. Similarly, the risks of midurethral sling have been well-documented, including the risk of pain after transobturator sling. Little attention has been given to whether this risk of postoperative pain varies based on patient BMI. Our previous work suggesting that leaner patients might be at increased risk of postoperative pain following transobturator sling was limited by the shortcomings of a retrospective study design. In this prospective study, we were able to adjust for age and activity level, finding that higher BMI women were at increased risk of postoperative pain, while reporting similar levels of satisfaction with the procedure. Future research is needed to find what differences in anatomy or physiology can explain this finding. From a clinical standpoint, thorough counselling of all patients but particularly those with elevated BMI, is required so that appropriate expectations regarding recovery can be set preoperatively.

Surgical Case Logging Habits and Attitudes: A Multispecialty Survey of Residents.

OBJECTIVE: The Accreditation Council for Graduate Medical Education measures surgical residents' experience in the United States by mandating that residents log each procedure in which they have participated. This system is the primary mechanism by which breadth and depth of surgical training are documented, and data are used for program accreditation and by individual program directors to assess resident preparedness. The study objective was to learn from residents across surgical specialties how this system is being used, and whether they believe these data are reliable. DESIGN: Investigators developed and administered a voluntary, 45-item survey. Resident demographic data, program details, logging behaviors, and attitudes were examined using descriptive statistics. Authors used multivariate logistic regression to assess respondent and program characteristics associated with logging habits. SETTING: The survey was administered at a large academic medical center. PARTICIPANTS: All general surgery, obstetrics and gynecology, orthopedics, urology, neurosurgery, otolaryngology, and plastic surgery residents were eligible. Of 126 surgical residents, 82 participated, yielding a response rate of 65%. RESULTS: Overall, 7.5% considered the case log system highly inaccurate, 28.8% somewhat inaccurate, 52.5% somewhat accurate, and 11.3% highly accurate. Nearly half (48.1%) use an incorrect metric to log their role as surgeon or assistant. Half logged monthly or less frequently. The longest time residents reported falling behind ranged from less than a week to more than a year, with about half (51.4%) reporting backlogs of 3 months or longer. Approximately two-thirds considered the system difficult to navigate (64.2%) and burdensome (68.8%). Departmental training and reminders to log were associated with high fidelity logging habits. CONCLUSIONS: Inconsistency of logging habits and perceived lack of accuracy raise concerns about use of the system for assessing surgical preparedness or accrediting training programs. Academic departments playing an active role may benefit from more reliable data to guide improvements in surgical training.

Preoperative vaginal estrogen and midurethral sling exposure: a retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: We evaluated whether the use of estrogen vaginally prior to synthetic midurethral sling insertion mediates the risk of mesh exposure. A secondary aim was to evaluate other factors that may be associated with mesh exposure. METHODS: We performed a retrospective cohort study of patients undergoing midurethral sling insertion from January to December 2010 within the Southern California Permanente Medical Group. Women who used estrogen vaginally prior to surgery were classified as those who filled a prescription between 1 and 45 days before surgery or whose medical records indicated its use at the time of preoperative evaluation. Logistic regression analysis was used to calculate odds ratios (OR) and 95 % confidence intervals (CI) for factors associated with mesh exposure while controlling for confounding variables. RESULTS: A total of 1544 patients met inclusion criteria, of whom 248 (16.1 %) used estrogen vaginally prior to surgery. Mean age was 53.7 years (range 27-89). Thirty-seven (2.4 %) women were diagnosed with mesh exposure, of whom 19 underwent surgical reoperation. In multivariate logistic regression analysis, preoperative use of estrogen vaginally was not associated with the risk of mesh exposure (OR 0.79, CI 0.26-2.38, p = 0.67). Age, body mass index, menopausal status, use of hormone replacement therapy, smoking status, and diabetes were not associated with risk of mesh exposure. CONCLUSIONS: Preoperative use of estrogen vaginally did not appear to mediate the risk of mesh exposure following midurethral sling placement in this cohort.

Characterization of pain after inside-out transobturator midurethral sling.

OBJECTIVES: This study aimed to evaluate the prevalence, severity, duration, and location of pain after transobturator midurethral sling. METHODS: We evaluated patients who underwent inside-out transobturator sling from March 2011 through February 2013. Presence of pelvic girdle pain, its severity, and location were documented preoperatively and at 2- and 6-week postoperative visits. Pain severity was measured on a scale of 1 to 10, with 10 being the "worst imaginable" pain. RESULTS: Of the 130 women analyzed, the median age was 50.0 years (interquartile range, 44.0-62.0). Thirty-nine percent of women reported preoperative pain, mostly mild with a median score of 1.0 (1.0-5.0). The most common sites of postoperative-onset pain were the lateral leg, medial leg, groin, and low back. Women reporting preoperative pain were not more likely to report postoperative-onset pain than women without preoperative pain (P = 0.42). Twelve percent of women at 2 weeks and 0.8% at 6 weeks reported severe postoperative-onset pain. Women reporting postoperative-onset pain were equally likely to be satisfied with the procedure as those without pain at 2 (P = 0.76) and 6 (P = 0.74) weeks. CONCLUSIONS: Women undergoing transobturator sling commonly report preoperative pain. An expected postoperative increase in pain generally resolved by the sixth postoperative week. The lateral leg was the most common site of pain. Postoperative-onset pain was not associated with decreased patient satisfaction.