Purpose-Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence.Materials and Methods-Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral Neuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.Results-Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920e37,440] vs $7,460 [95% CI 5,780e9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787e38,309] vs $12,020 [95% CI 10,330e13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (−3.00 [95% CI −3.38 e −2.62] vs −3.12 [95% CI −3.48 e −2.76], p[0.66) or QALYs (1.39 [95% CI 1.34e1.44] vs 1.41 [95% CI 1.36e1.45], p[0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.
ObjectivesCompared with surgery under general anesthesia (GA), surgery under neuraxial regional anesthesia (RA) has been associated with economic and clinical benefits in certain populations. Our aim was to compare preoperative and postoperative characteristics and 30-day outcomes, including intraoperative complications, for patients undergoing benign vaginal hysterectomy under GA versus RA.MethodsThis is a retrospective cohort study of patients who underwent vaginal hysterectomy for benign indications between 2015 and 2019 using the American College of Surgeons National Surgical Quality Improvement Program database. Patients were identified using Current Procedural Terminology codes and stratified into GA and RA groups. Propensity score matching was performed to account for selection bias between anesthesia groups.ResultsOf 18,030 vaginal hysterectomies performed during this study period, 17,472 (96.9%) were performed under GA and 558 (3.1%) under RA. The RA group was older, more likely to be White, and more likely to have a history of chronic obstructive pulmonary disease and chronic steroid use (P < 0.01 for all); they were less likely to be discharged the same day (8.6% vs 12.2%, P = 0.01). In the matched cohort, there were similar proportions of major, minor, and composite complications between RA and GA groups (major: odds ratio [OR], 0.95; 95% confidence interval [CI], 0.51–1.78; minor: OR, 1.18; 95% CI, 0.74–1.88; composite: OR, 1.10; 95% CI, 0.75–1.64). Similar proportions of same-day discharge were observed (OR, 0.72; 95% CI, 0.47–1.10).ConclusionsAlthough RA comprises only 3% of the anesthetic modalities used for benign vaginal hysterectomies, it is associated with a similar incidence of postoperative complications compared with general anesthesia.
ObjectiveThe primary aim of this study was to review trends in the same-day discharge (SDD) rate after minimally invasive sacrocolpopexy (MISCP). The secondary aim was to compare the composite 30-day postoperative complication rates between propensity score–matched SDD and admitted cohorts.MethodsThis was a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database from 2015 to 2019. Patients who underwent MISCP were identified by Current Procedural Terminology codes. Concurrent hysterectomy, anterior or posterior repairs, rectopexy, and midurethral sling were also identified. Multivariable logistic regression and propensity score matching were performed.ResultsA total of 12,762 MISCP patients were captured: 3,968 underwent MISCP only, 4,065 underwent MISCP with total laparoscopic hysterectomy, 734 underwent MISCP with laparoscopically assisted vaginal hysterectomy, and 3,995 underwent MISCP with laparoscopic supracervical hysterectomy. Overall, the SDD rate was 16.3%, with an increase from 12.3% in 2015 to 23.1% in 2019. Multivariable logistic regression showed that admitted patients were more likely to be older, to be of Black race, have an American Society of Anesthesiologists classification of 3 or 4, have hypertension requiring medication, have longer operative time, and have undergone concurrent anterior or posterior repair, rectopexy, or sling. After propensity score matching, the composite postoperative complication rates were similar between the 2 cohorts (5.7% vs 6.4%, P = 0.818). However, superficial surgical site infection was more likely in the SDD cohort (adjusted odds ratio, 2.3; P < 0.001) and blood transfusion in the admitted cohort (adjusted odds ratio, 11.9; P = 0.0.34).ConclusionsThe rate of SDD after MISCP seems to be increasing. Composite postoperative complication rates are similar between SDD and admitted cohorts.
INTRODUCTION: To compare the cost effectiveness of pretreatment with mifepristone to misoprostol alone in women seeking medical management of nonviable early pregnancy. METHODS: This within-trial comparison included 300 women with anembryonic gestation or embryonic/fetal demise randomized to off-label misoprostol 800 mcg vaginally or off-label mifepristone 200 mg followed 24 hours later by misoprostol. The primary outcome was gestational sac expulsion with one dose of misoprostol. Both healthcare and societal sector perspectives were adopted to calculate the incremental cost effectiveness ratio (ICER), expressed as cost per quality-adjusted life-year (QALY) gained. Costs included medical treatment and complications, patient and caregiver time, transportation, and lost productivity over the 30-day study period. Results are in 2018 US dollars. QALYs were based on a modified utility score, with successful medical therapy defined as 1 and need for uterine aspiration defined as 0.95. This study was approved by the University of Pennsylvania Institutional Review Board. RESULTS: Complete expulsion rate after one misoprostol dose was 124/148 (83.8%) with mifepristone pretreatment versus 100/149 (67.1%) after misoprostol alone. Uterine aspiration was required for 13 (8.8%) women after mifepristone pretreatment and 35 (23.5%) women after misoprostol alone. In the healthcare sector analysis mifepristone pretreatment was less expensive ($657 vs. $658 mean per-person cost) and more effective (0.08 vs. 0.07 QALYs gained) than misoprostol alone. Analysis from the societal perspective again demonstrated that mifepristone pretreatment was both less expensive ($3,807 vs. $4,819) and more effective than misoprostol alone. CONCLUSION: Pretreatment with mifepristone is the economically dominant strategy as it is both cost saving and more effective.
OBJECTIVES:To evaluate factors associated with the development of vesicovaginal fistula following a cystotomy during benign hysterectomy at two large university settings. MATERIALS AND METHODSCharts from all hysterectomies performed for benign indications at Grady Memorial Hospital and the University of Mississippi Medical Center between January 1, 2000 and December 31, 2008 were reviewed. Demographic and operative data were abstracted. Cystotomies were scored using the American Association for the Surgery of Trauma (AAST) grading system for iatrogenic bladder injuries. Cases were patients who developed a vesicovaginal fistula (VVF) following cystotomy while patients who had a bladder injury without development of a VVF served as the controls. The Fisher's exact test was used to analyze categorical variables while the Student's t-test was used for continuous variables. Odds ratios with 95% confidence intervals were calculated for risk factors. RESULTS:During the study period, 5786 hysterectomies were performed for benign indications at the two study centers. Of these, 59% were abdominal, 34% vaginal and 7% were laparoscopic assisted hysterectomies. A total of 90 (1.6%) cystotomies occurred. Vesicovaginal fistulas developed in seven (7.8%) patients. No significant differences in age, parity, weight or ethnicity were identified between those developing a VVF and those who did not. No significant differences in the rate of tobacco use, hypertension, diabetes, prior Cesarean delivery, prior sexually transmitted infections, pelvic adhesive disease or prior pelvic surgeries were seen. The route or indication for hysterectomy did not differ between the groups. The mean uterine weight and operative blood loss did not differ between the groups, however, patients who developed a VVF were more likely to have a uterus that weighed more than 250 g (83% vs 36%, P ϭ 0.03) and a trend towards an operative blood loss of greater than 1000 mL (67% vs 27%, P ϭ 0.06). Patients who developed a VVF had longer operative time (317 Ϯ 82 vs 206 Ϯ 10 minutes, P ϭ 0.02) and were more likely to have an associated ureteral injury (29% vs 1%, P ϭ 0.02). An AAST Grade V bladder injury (OR: 30.80, 95% CI: 4.50 -210.79) and one layer repair of the bladder (OR: 7.20, 95% CI: 1.05-49.32) were associated with VVF formation. CONCLUSION:Patients with an AAST Grade V bladder injury or those whose bladder is repaired in a single layer are at increased risk for developing a vesicovaginal fistula following a cystotomy during a hysterectomy performed for benign indications. OBJECTIVES:To systematically review and synthesize published literature on sacral neuromodulation for the treatment of urinary urgency, frequency and urge urinary incontinence. MATERIALS AND METHODS: Vanderbilt University's Evidence-basedPractice Center was contracted by the Agency for Healthcare Research and Quality to review the literature on the Management of Overactive Bladder, including sacral neuromodulation. Literature published in English from January 1966 to October 2008 and ind...
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