A bundle of opioid-sparing strategies to eliminate routine opioid prescribing in a urogynecology practice.

BACKGROUND: Current evidence supports that many patients do not use prescribed opioids following reconstructive pelvic surgery, yet it remains unclear if it is feasible to eliminate routine opioid prescriptions without a negative impact on patients or providers. OBJECTIVE: To determine if there is a difference in the proportion of patients discharged without opioids after implementing a bundle of opioid-sparing strategies and tiered prescribing protocol compared to usual care after minimally invasive pelvic reconstructive surgery (transvaginal, laparoscopic, or robotic). Secondary objectives include measures of patient-perceived pain control and provider workload. STUDY DESIGN: The bundle of opioid-sparing strategies and tiered prescribing protocol intervention was implemented as a division-wide evidence-based practice change on August 1, 2022. This retrospective cohort compares a 6-month postintervention (bundle of opioid-sparing strategies and tiered prescribing protocol) cohort to 6-month preintervention (usual care) of patients undergoing minimally invasive pelvic reconstructive surgery. A 3-month washout period was observed after bundle of opioid-sparing strategies and tiered prescribing protocol initiation. We excluded patients <18 years, failure to consent to research, combined surgery with other specialties, urge urinary incontinence or urinary retention procedures alone, and minor procedures not typically requiring opioids. Primary outcome was measured by proportion discharged without opioids and total oral morphine equivalents prescribed. Pain control was measured by pain scores, postdischarge prescriptions and refills, phone calls and visits related to pain, and satisfaction with pain control. Provider workload was demonstrated by phone calls and postdischarge prescription refills. Data were obtained through chart review on all patients who met inclusion criteria. Primary analysis only included patients prescribed opioids according to the bundle of opioid-sparing strategies and tiered prescribing protocol protocol. Two sample t tests compared continuous variables and chi-square tests compared categorical variables. RESULTS: Four hundred sixteen patients were included in the primary analysis (207 bundle of opioid-sparing strategies and tiered prescribing protocol, 209 usual care). Baseline demographics were similar between groups, except a lower proportion of irritable bowel syndrome (13% vs 23%; P<.01) and pelvic pain (15% vs 24.9%; P=.01), and higher history of prior gynecologic surgery (69.1% vs 58.4%; P=.02) in the bundle of opioid-sparing strategies and tiered prescribing protocol cohort. The bundle of opioid-sparing strategies and tiered prescribing protocol cohort was more likely to be discharged without opioids (68.1% vs 10.0%; P<.01). In those prescribed opioids, total oral morphine equivalents on discharge was significantly lower in the bundle of opioid-sparing strategies and tiered prescribing protocol cohort (48.1 vs 81.8; P<.01). The bundle of opioid-sparing strategies and tiered prescribing protocol cohort had a 20.6 greater odds (confidence interval 11.4, 37.1) of being discharged without opioids after adjusting for surgery type, arthritis/joint pain, IBS, pelvic pain, and contraindication to nonsteroidal anti-inflammatory drugs. The bundle of opioid-sparing strategies and tiered prescribing protocol cohort was also less likely to receive a rescue opioid prescription after discharge (1.4% vs 9.5%; P=.03). There were no differences in opioid prescription refills (19.7% vs 18.1%; P=.77), emergency room visits for pain (3.4% vs 2.9%; P=.76), postoperative pain scores (mean 4.7 vs 4.0; P=.07), or patient satisfaction with pain control (81.5% vs 85.6%; P=.21). After bundle of opioid-sparing strategies and tiered prescribing protocol implementation, the proportion of postoperative phone calls for pain also decreased (12.6% vs 21.5%; P=.02). Similar results were identified when nonadherent prescribing was included in the analysis. CONCLUSION: A bundle of evidence-based opioid sparing strategies and tiered prescribing based on inpatient use increases the proportion of patients discharged without opioids after minimally invasive pelvic reconstructive surgery without evidence of uncontrolled pain or increased provider workload.

Defining success after surgical treatment of stress urinary incontinence.

BACKGROUND: A consensus standardized definition of success after stress urinary incontinence surgical treatment is lacking, which precludes comparisons between studies and affects patient counseling. OBJECTIVE: This study aimed to identify optimal patient-centric definition(s) of success after stress urinary incontinence surgical treatment and to compare the identified "more accurate" treatment success definitions with a commonly used composite definition of success (ie, no reported urine leakage, negative cough stress test result, and no retreatment). STUDY DESIGN: We evaluated 51 distinct treatment success definitions for participants enrolled in a previously conducted randomized trial of stress urinary incontinence treatments concomitantly performed with sacrocolpopexy (NCT00934999). For each treatment success definition, we calculated the mean (SD) of participant-assessed symptom improvement and participant-assessed surgical success scores with an 11-point Likert scale among those achieving success and failure. The "more accurate" treatment success definition(s) were identified by measuring the magnitude of the mean difference of participant assessments with Hedges g values. The treatment success definitions with the highest Hedges g values were considered "more accurate" treatment success definitions and were then compared with the composite definition of success. RESULTS: The percentage of participants who had treatment success (6.4% to 97.3%) and Hedges g values (-4.85 to 1.25) varied greatly according to each treatment success definition. An International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ≤5, Urogenital Distress Inventory-6 score ≤33.3, and a no/mild stress urinary incontinence response on Urogenital Distress Inventory-6 question 3 had the highest Hedges g values and were considered the top 3 "more accurate" treatment success definitions. Paradoxically, treatment success definitions that required a negative cough stress test result or no persistent urinary leakage greatly reduced the ability to differentiate between participant-assessed symptom improvement and surgical success. When the "more accurate" treatment success definitions were compared with the composite definition, patients with failed treatment according to the composite definition had lower Urinary Impact Questionnaire-7 scores and a higher proportion of survey responses indicating complete satisfaction or some level of satisfaction and very good/perfect bladder condition. In addition, the composite definition had considerably fewer favorable outcomes for participants than did the top 3 "more accurate" treatment success definitions. CONCLUSION: Successful outcomes of stress urinary incontinence surgical treatments for women undergoing concurrent sacrocolpopexy varied greatly depending on the definition used. However, stringent definitions (requiring complete dryness) and objective testing (negative cough stress test result) had decreased, rather than increased, participant-assessed symptom improvement and surgical success scores. The "more accurate" treatment success definitions better differentiated between participant-assessed symptom improvement and surgical success than the composite definition. The composite definition disproportionately misidentified participants who reported minor symptoms or complete/partial satisfaction with their outcome as having treatment failures and yielded a considerably lower proportion of women who reported favorable outcomes than did the top 3 "more accurate" treatment success definitions.

The Impact of an Overactive Bladder Care Pathway on Longitudinal Patient Management.

IMPORTANCE: Implementation of an overactive bladder (OAB) care pathway may affect treatment patterns and progression. OBJECTIVES: This study aimed to assess the effect of OAB care pathway implementation on treatment patterns for women with OAB. STUDY DESIGN: This retrospective cohort study evaluated women with OAB, before (January 1, 2015-December 31, 2017) and after (January 1, 2019-December 31, 2021) care pathway initiation. Care pathway use included standardized counseling, early introduction of therapy, and close follow-up. Primary outcomes included OAB medication use, follow-up visits, third-line therapy, and time to third-line therapy. RESULTS: A total of 1,349 women were included: 1,194 before care pathway implementation and 155 after. Patients after implementation were more likely to have diabetes mellitus (P = 0.04) and less likely to smoke (P = 0.01). Those managed via a care pathway were more likely to use any medication or third-line therapy within 1 year after consultation (61.3% vs 25.0%; P < 0.001). This included higher proportions receiving a medication (50.3% [95% confidence interval (CI), 41.8%-57.6%] vs 23.3% [95% CI, 20.9%-25.7%]; P < 0.001) and progressing to third-line therapy (22.6% [95% CI, 15.7%-28.9%] vs 2.9% [95% CI, 2%-3.9%]; P < 0.001). Among those who underwent third-line treatment, care pathway use was associated with shorter time to third-line therapy (median, 10 days [interquartile range, 1-56 days] vs 29 days [interquartile range, 7-191 days]; P = 0.013). Those managed via a care pathway were less likely to have additional clinic visits for OAB within 1 year after initial consultation (12.3% vs 23.9%; P < 0.001). CONCLUSIONS: Use of an OAB care pathway was associated with higher rates of oral medication and third-line therapy yet decreased follow-up office visits. Use of an OAB care pathway may promote consistent and efficient care for women with OAB.

Evaluating the Long-term Impact of Implementing Standardized Postoperative Opioid Prescribing Recommendations Following Pelvic Organ Prolapse Surgery.

IMPORTANCE: Improving opioid stewardship is important, given the common use of opioids and resultant adverse events. Evidence-based prescribing recommendations for surgeons may help reduce opioid prescribing after specific procedures. OBJECTIVE: The aim of this study was to assess longitudinal prescribing patterns for patients undergoing pelvic organ prolapse surgery in the 2 years before and after implementing evidence-based opioid prescribing recommendations. STUDY DESIGN: In December 2017, a 3-tiered opioid prescribing recommendation was created based on prospective data on postoperative opioid use after pelvic organ prolapse surgery. For this follow-up study, prescribing patterns, including quantity of opioids prescribed (in oral morphine equivalents [OMEs]) and refill rates, were retrospectively compared for patients undergoing prolapse surgery before (November 2015-November 2017; n = 238) and after (December 2017-December 2019; n = 361) recommendation implementation. Univariate analysis was performed using the Wilcoxon rank sum and χ2 tests. Cochran-Armitage trend tests and interrupted time-series analysis tested for significance in the change in OMEs prescribed before versus after recommendation implementation. RESULTS: After recommendation implementation, the quantity of postoperative opioids prescribed decreased from median 225 mg OME (interquartile range, 225, 300 mg OME) to 71.3 mg OME (interquartile range, 0, 112.5 mg OME; P < 0.0001). Decreases also occurred within each subgroup of prolapse surgery: native tissue vaginal repair ( P < 0.0001), robotic sacrocolpopexy ( P < 0.0001), open sacrocolpopexy ( P < 0.0001), and colpocleisis ( P < 0.003). The proportion of patients discharged following prolapse surgery without opioids increased (4.2% vs 36.6%; P < 0.0001), and the rate of opioid refills increased (2.1% vs 6.0%; P = 0.02). CONCLUSIONS: With 2 years of postimplementation follow-up, the use of procedure-specific, tiered opioid prescribing recommendations at our institution was associated with a significant, sustained reduction in opioids prescribed. This study further supports using evidence-based recommendations for opioid prescribing.

Abdominal and robotic sacrocolpopexy costs following implementation of enhanced recovery after surgery.

OBJECTIVE: To compare perioperative costs and morbidity between open and robotic sacrocolpopexy after implementation of enhanced recovery after surgery (ERAS) pathway. METHODS: The present retrospective cohort study of patients undergoing open or robotic sacrocolpopexy (January 1, 2014, through November 30, 2017) used an ERAS protocol with liposomal bupivacaine infiltration of laparotomy incisions. Primary outcomes were costs associated with index surgery and hospitalization, determined with Medicare cost-to-charge ratios and reimbursement rates and adjusted for variables expected to impact costs. Secondary outcomes included narcotic use, length of stay (LOS), and complications from index hospitalization to postoperative day 30. RESULTS: For the total of 231 patients (open cohort, 90; robotic cohort, 141), the adjusted mean cost of robotic surgery was $3239 higher compared with open sacrocolpopexy (95% confidence interval [CI] $1331-$5147; P < 0.001). Rates were not significantly different for intraoperative complications (robotic, 4.3% [6/141]; open, 5.6% [5/90]; P = 0.754), 30-day postoperative complications (robotic, 11.4% [16/141]; open, 16.7% [15/90]; P = 0.322), or readmissions (robotic, 5.7% [8/141]; open, 3.3% [3/90]; P = 0.535). The percentage of patients dismissed on postoperative day 1 was greater in the robotic group (89.4% [126/141] vs. 48.9% [44/90], P < 0.001). CONCLUSIONS: Decreased LOS associated with ERAS provided significant cost savings with open sacrocolpopexy versus robotic sacrocolpopexy without adverse impacts on perioperative complications or readmissions.

Exosome biopotentiated hydrogel restores damaged skeletal muscle in a porcine model of stress urinary incontinence.

Urinary incontinence afflicts up to 40% of adult women in the United States. Stress urinary incontinence (SUI) accounts for approximately one-third of these cases, precipitating ~200,000 surgical procedures annually. Continence is maintained through the interplay of sub-urethral support and urethral sphincter coaptation, particularly during activities that increase intra-abdominal pressure. Currently, surgical correction of SUI focuses on the re-establishment of sub-urethral support. However, mesh-based repairs are associated with foreign body reactions and poor localized tissue healing, which leads to mesh exposure, prompting the pursuit of technologies that restore external urethral sphincter function and limit surgical risk. The present work utilizes a human platelet-derived CD41a and CD9 expressing extracellular vesicle product (PEP) enriched for NF-κB and PD-L1 and derived to ensure the preservation of lipid bilayer for enhanced stability and compatibility with hydrogel-based sustained delivery approaches. In vitro, the application of PEP to skeletal muscle satellite cells in vitro drove proliferation and differentiation in an NF-κB-dependent fashion, with full inhibition of impact on exposure to resveratrol. PEP biopotentiation of collagen-1 and fibrin glue hydrogel achieved sustained exosome release at 37 °C, creating an ultrastructural "bead on a string" pattern on scanning electron microscopy. Initial testing in a rodent model of latissimus dorsi injury documented activation of skeletal muscle proliferation of healing. In a porcine model of stress urinary incontinence, delivery of PEP-biopotentiated collagen-1 induced functional restoration of the external urethral sphincter. The histological evaluation found that sustained PEP release was associated with new skeletal muscle formation and polarization of local macrophages towards the regenerative M2 phenotype. The results provided herein serve as the first description of PEP-based biopotentiation of hydrogels implemented to restore skeletal muscle function and may serve as a promising approach for the nonsurgical management of SUI.

Impact of enhanced recovery implementation in women undergoing abdominal sacrocolpopexy.

OBJECTIVE: To assess the effect of Enhanced Recovery After Surgery (ERAS) with and without liposomal bupivacaine (LB) on opioid use, hospital length of stay (LOS), costs, and morbidity of women undergoing sacrocolpopexy. METHODS: Retrospective cohort of women who underwent abdominal sacrocolpopexy between April 1, 2009 and November 30, 2017. Costs for relevant healthcare services were determined by assigning 2017 charges multiplied by 2017 Medicare Cost Report's cost to charge ratios. Outcomes were compared among periods with multivariable regression models adjusted for age, American Society of Anesthesiologists score, and concurrent hysterectomy and posterior repair. RESULTS: Patients were subdivided into pre-ERAS (G1, n = 128), post-ERAS (G2, n = 83), and post-ERAS plus LB (G3, n = 91). The proportion of patients needing opioids during postoperative days 0-2 was significantly less for G3 (75.8%) compared with G1 (97.7%) and G2 (92.8%); P < 0.001). The median morphine equivalent units (MEU) with interquartile ranges, mean LOS, and adjusted mean standardized costs were significantly lower in G3 compared with the other two groups (35 [20-75] vs. 67 [31-109], and 60 [30-122] MEUs; 1.8 vs. 2.3 vs. 2.9 days; and $2391, $2975, and $3844, for G3, G2, and G1, respectively; P < 0.001). CONCLUSION: Implementation of an ERAS pathway led to significant decreases in opioid use, LOS, and costs. Supplementation with LB further improved these measures.

Comparison of outcomes between pessary use and surgery for symptomatic pelvic organ prolapse: A prospective self-controlled study.

PURPOSE: We compared the degree of pelvic floor symptom improvement between pessary use and prolapse surgery. MATERIALS AND METHODS: Pessary-naïve women who elected prolapse surgery were enrolled and used a pessary preoperatively (for ≥7 days and ≤30 days). Pelvic floor symptoms were assessed at baseline, after pessary use, and at 3 months postoperatively. The primary outcome was concordance in the degree of symptoms improvement between pessary use and surgery, as assessed by Patient Global Impression of Improvement (PGI-I). Secondary outcomes were related to prolapse specific symptoms on validated questionnaires (POPDI-6, PFIQ-7). The McNemar test was used for comparisons of discordant pairs for comparisons of the PGI-I ratings after pessary use and surgery. RESULTS: Sixty-one participants were enrolled (March 2016 through April 2019) and 58 patients used a pessary. Mean±standard deviation age was 60.7±10.7 years; 24.1% had prior hysterectomy, and 13.8% had prior prolapse surgery. While both treatments demonstrated symptomatic improvement, concordance in the degree of overall improvement on the PGI-I score was poor (n=40); responses significantly favored more improvement postoperatively (p<0.001). Pessary use and surgery were associated with significant improvements in prolapse symptoms from baseline on POPDI-6 (both p<0.001) and POPIQ-7 (pessary, p=0.002; surgery, p<0.001). The degree of improvement was larger postoperatively compared to post-pessary use on POPDI-6 (p<0.001) and PFIQ-7 (p=0.004). CONCLUSIONS: Both pessary use and surgery significantly improved pelvic floor symptoms from baseline. However, concordance in degrees of improvement between these treatments was poor, with more favorable outcomes after surgery for prolapse symptoms.

Introduction to Machine Learning in Obstetrics and Gynecology.

In the digital age of the 21st century, we have witnessed an explosion in data matched by remarkable progress in the field of computer science and engineering, with the development of powerful and portable artificial intelligence-powered technologies. At the same time, global connectivity powered by mobile technology has led to an increasing number of connected users and connected devices. In just the past 5 years, the convergence of these technologies in obstetrics and gynecology has resulted in the development of innovative artificial intelligence-powered digital health devices that allow easy and accurate patient risk stratification for an array of conditions spanning early pregnancy, labor and delivery, and care of the newborn. Yet, breakthroughs in artificial intelligence and other new and emerging technologies currently have a slow adoption rate in medicine, despite the availability of large data sets that include individual electronic health records spanning years of care, genomics, and the microbiome. As a result, patient interactions with health care remain burdened by antiquated processes that are inefficient and inconvenient. A few health care institutions have recognized these gaps and, with an influx of venture capital investments, are now making in-roads in medical practice with digital products driven by artificial intelligence algorithms. In this article, we trace the history, applications, and ethical challenges of the artificial intelligence that will be at the forefront of digitally transforming obstetrics and gynecology and medical practice in general.

Cost-effectiveness Analysis of Early Sling Loosening Versus Delayed Sling Lysis in the Management of Voiding Dysfunction After Midurethral Sling Placement.

OBJECTIVE: The aim of this study was to perform a cost-effectiveness analysis comparing the management for ongoing voiding dysfunction after midurethral sling placement, including early sling loosening and delayed sling lysis. METHODS: A Markov model was created to compare the cost-effectiveness of early sling loosening (2 weeks) versus delayed sling lysis (6 weeks) for the management of persisting voiding dysfunction/retention after midurethral sling placement. A literature review provided rates of resolution of voiding dysfunction with conservative management, complications, recurrent stress urinary incontinence, or ongoing retention, as well as quality-adjusted life years (QALYs). Costs were based on 2020 Medicare reimbursement rates. Incremental cost-effectiveness ratios were compared using a willingness-to-pay threshold of $100,000/QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS: At 1 year, early sling loosening resulted in increased costs ($3,575 vs $1,836) and higher QALYs (0.948 vs 0.925) compared with delayed sling lysis. This translated to early sling loosening being the most cost-effective strategy, with an incremental cost-effectiveness ratio of $74,382/QALY. The model was sensitive to multiple variables on our 1-way sensitivity analysis. For example, delayed sling lysis became cost-effective if the rate of voiding dysfunction resolution with conservative management was greater than or equal to 57% or recurrent stress urinary incontinence after early loosening was greater than or equal to 9.6%. At a willingness-to-pay threshold of 100,000/QALY, early sling loosening was cost-effective in 82% of microsimulations in probabilistic sensitivity analysis. CONCLUSIONS: Early sling loosening represents a more cost-effective management method in resolving ongoing voiding dysfunction after sling placement. These findings may favor early clinical management in patients with voiding dysfunction after midurethral sling placement.

Exosome-Induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model.

OBJECTIVES: The purpose of this study was to explore the utility of an injectable purified exosome product derived from human apheresis blood to (1) augment surgical closure of vaginal mesh exposures, and (2) serve as a stand-alone therapy for vaginal mesh exposure. METHODS: Sixteen polypropylene meshes (1×1-3×3 cm) were implanted in the vaginas of 7 Yorkshire-crossed pigs by urogynecologic surgeons (day 0). On day 7, group 1 underwent surgical intervention via vaginal tissue suture reclosure with (n=2 pigs, n=4 meshes) or without (n=2 pigs, n=4 meshes) exosome injection; group 2 underwent medical intervention with an exosome injection (n=3, n=8 meshes). One animal in group 2 was given oral 2'-deoxy-5-ethynyluridine to track cellular regeneration. Euthansia occurred at 5 weeks. RESULTS: Mesh exposures treated with surgical closure alone experienced reexposure of the mesh. Exosome treatment with or without surgical closure resulted in partial to full mesh exposure resolution up to 3×3 cm. Exosome-treated tissues had significantly thicker regenerated epithelial tissue (208 µm exosomes-only and 217 µm surgery+exosomes, versus 80 µm for surgery-only; P < 0.05); evaluation of 2'-deoxy-5-ethynyluridine confirmed de novo regeneration throughout the epithelium and underlying tissues. Capillary density was significantly higher in the surgery+exosomes group (P = 0.03). Surgery-only tissues had a higher inflammatory and fibrosis response as compared with exosome-treated tissues. CONCLUSIONS: In this pilot study, exosome treatment augmented healing in the setting of vaginal mesh exposure, reducing the incidence of mesh reexposure after suture closure and decreasing the area of mesh exposure through de novo tissue regeneration after exosome injection only. Further study of varied local tissue conditions and mesh configurations is warranted.

Impact of Repeat Dosing and Mesh Exposure Chronicity on Exosome-Induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model.

OBJECTIVE: The aim of the study was to compare vaginal wound healing after exosome injection in a porcine mesh exposure model with (1) single versus multiple dose regimens and (2) acute versus subacute exposure. METHODS: Six 80-kg Yorkshire-crossed swine each had 2 polypropylene meshes implanted to create the vaginal mesh exposure model. Animals were divided into 3 groups based on number and timing of exosome injection: (1) single purified exosome product (PEP) injection (acute-single), (2) weekly PEP injections (acute-weekly, 4 total injections), and (3) delayed single injection (subacute-single). Acute and subacute injections occurred 1 and 8 weeks after mesh implantation, respectively. EdU, a thymidine analog, was given twice weekly after the first injection to track tissue regeneration. Euthanasia and tissue analysis occurred 4 weeks after the first injection. ImageJ was used to quantify epithelial thickness, cellular proliferation, and capillary density. Statistical analysis was performed using analysis of variance and post hoc Tukey test. RESULTS: Acute-single PEP injection tissues mirrored pilot study results, validating replication of protocol. Within the acute groups, weekly dosing resulted in 1.5× higher epithelial thickness (nonsignificant), 1.8× higher epithelial proliferation (P < 0.05), and 1.5× higher regenerated capillary density (P < 0.05) compared with single injection. Regarding chronicity of the exposure, the subacute group showed 1.7× higher epithelial proliferation (nonsignificant) and similar capillary density and epithelial thickness as compared with the acute group. CONCLUSIONS: Exosome redosing resulted in significantly greater epithelial proliferation with significantly higher regenerated capillary density, leading to a trend toward thicker epithelium. Subacute exposure exhibited similar regeneration to acute exposure despite a delayed injection timeline. These results contribute to a growing body of preclinical research demonstrating utility of exosomes in pelvic floor disorders.

Reoperation for Urinary Incontinence After Retropubic and Transobturator Sling Procedures.

OBJECTIVE: To compare the reoperation rates for recurrent stress urinary incontinence (SUI) after retropubic and transobturator sling procedures. METHODS: We conducted a retrospective cohort study of all women who underwent midurethral sling procedures at a single institution for primary SUI between 2002 and 2012. To minimize bias, women in the two groups were matched on age, body mass index, isolated compared with combined procedure, and preoperative diagnosis. The primary outcome was defined as reoperation for recurrent SUI. Secondary outcomes included intraoperative complications and mesh-related complications requiring reoperation after the index sling procedure. RESULTS: We identified 1,881 women who underwent a sling procedure for primary SUI-1,551 retropubic and 330 transobturator. There was no difference between groups in any of the evaluated baseline variables in the covariate-matched cohort of 570 with retropubic slings and 317 with transobturator slings; results herein are based on the covariate-matched cohort. Women undergoing a transobturator sling procedure had an increased risk of reoperation for recurrent SUI compared with women undergoing a retropubic sling procedure (hazard ratio 2.42, 95% CI 1.37-4.29). The cumulative incidence of reoperation for recurrent SUI by 8 years was 5.2% (95% CI 3.0-7.4%) in the retropubic group and 11.2% (95% CI 6.4-15.8%) in the transobturator group. Women in the retropubic group had a significantly higher rate of intraoperative complications compared with women in the transobturator group (13.7% [78/570] vs 4.7% [15/317]; difference=9.0%, 95% CI for difference 5.3-12.6%); the majority of this difference was due to bladder perforation (7.0% [40/570] vs 0.6% [2/317]; difference=6.4%, 95% CI for difference 4.1-8.7%). The cumulative incidence of sling revision for urinary retention plateaued at 3.2% and 0.4% by 5 years in the two groups. CONCLUSION: Women with primary SUI treated with a retropubic sling procedure have significantly lower cumulative incidence of reoperation for recurrent SUI compared with women who were treated with a transobturator sling procedure. Retropubic slings were associated with a higher risk of sling revision for urinary retention.

Assessing the impact of procedure-specific opioid prescribing recommendations on opioid stewardship following pelvic organ prolapse surgery.

BACKGROUND: Nationally, there is increasing concern regarding the volume of opioid medications prescribed postoperatively and the rate of prescription opioid-related adverse events. In evaluation of this, several reports have identified significant variability in postoperative opioid-prescribing patterns, including quantities exceeding patient's needs, especially after minor surgical procedures. However, data regarding patient's postoperative opioids needs following surgery for pelvic organ prolapse are sparse. OBJECTIVE: To design procedure-specific opioid-prescribing recommendations for pelvic organ prolapse surgeries and evaluate their impact on opioid stewardship. STUDY DESIGN: We prospectively evaluated opioid-prescribing patterns, patient use, medication refills, and patient satisfaction in women undergoing prolapse surgery (ie, vaginal, abdominal, or robotic) during an 8-month time period. Two cohorts of women, stratified by whether they had surgery before or after implementation of procedure-specific opioid-prescribing recommendations, were evaluated. Postoperative opioid usage (assessed via pill count), medication refills, and satisfaction with pain management after hospital dismissal were evaluated by telephone call 2 weeks after surgery. Postoperative opioid prescribing and use were recorded after conversion to oral morphine equivalents. RESULTS: Overall, 96 women were included, 57 in the initial baseline cohort, and 39 following implementation of the prescribing recommendations. In the initial cohort, 32.8% of the prescribed oral morphine equivalents (3607/11,007 mg) were consumed. Following implementation of the prescribing recommendations, median oral morphine equivalents prescribed decreased from 200 mg oral morphine equivalents (interquartile range 150, 225) to 112.5 mg oral morphine equivalents (interquartile range 22.5, 112.5; P<.0001). The total oral morphine equivalents prescribed decreased by 45% when compared with the volume that would have been prescribed before implementing the recommendations. The amount of leftover opioids per patient significantly decreased as well (P<.0001). Pain medication refills increased after the intervention (18% vs 3.5%; P=.03), whereas satisfaction scores were similar in both cohorts (P=.87). CONCLUSIONS: By using procedure-specific opioid prescribing recommendations, we decreased the number of opioids prescribed at hospital dismissal by roughly one half. Decreased opioid prescribing did not adversely impact patient satisfaction.

Can Urodynamic Parameters Predict Sling Revision for Voiding Dysfunction in Women Undergoing Synthetic Midurethral Sling Placement?

OBJECTIVE: The objective of the study was to evaluate the utility of urodynamic studies performed before primary midurethral sling placement for stress urinary incontinence in predicting the need for subsequent sling release for voiding dysfunction. METHODS: The health records of women managed with primary synthetic midurethral sling placement at Mayo Clinic (Rochester, MN) from January 1, 2002, to December 31, 2012, were reviewed. The primary outcome was surgical sling release for postoperative voiding dysfunction (ie, prolonged retention, elevated postvoid residual volumes with new voiding symptoms, or de novo onset or worsening of overactive bladder symptoms). Logistic regression models were used to evaluate associations between potential clinical risk factors and the primary outcome. RESULTS: Overall, 1629 women underwent primary synthetic midurethral sling placement during the study time frame, including 1081 patients (66%) who underwent a preoperative multichannel urodynamic evaluation. A sling release for voiding dysfunction was performed for 51 patients (3.1%) at a median of 1.9 months postoperatively (interquartile range, 1.3-9.3 months). Patients undergoing sling release were significantly more likely to have had retropubic sling placement (P = 0.003) and concomitant prolapse surgery (P = 0.005). On univariate analysis, no urodynamic parameters were associated with the risk of sling release; evaluated parameters included peak flow rate (P = 0.20), postvoid residual volume (P = 0.37), voiding without detrusor contraction (P = 0.96), and detrusor pressure at maximal flow (P = 0.23). CONCLUSIONS: Sling release for voiding dysfunction was rare in our cohort. No urodynamic parameters were associated with the risk of sling release.

Randomized controlled trial of silver-alloy-impregnated suprapubic catheters versus standard suprapubic catheters in assessing urinary tract infection rates in urogynecology patients.

INTRODUCTION AND HYPOTHESIS: Catheter-associated urinary tract infections (UTI) are the most common health-care-related infections. We aimed to compare the UTI rate among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter (SPC) and a standard SPC, and identify the risk factors predisposing patients to UTI. METHODS: Patients who were to undergo placement of an SPC as part of pelvic organ prolapse surgery were enrolled between 1 August 2011 and 30 August 2017, and randomized to either standard SPC or silver-alloy SPC. Follow-up was performed at a postoperative visit or via a phone call at 6 weeks. The primary outcome was UTI. RESULTS: Of the 288 patients who were randomized, 127 with standard SPC and 137 with silver-alloy SPC were included in the analysis. Twenty-nine out of 123 women with standard SPC (23.6%) and 24 out of 131 (18.3%) with silver-alloy SPC were diagnosed with UTI within 6 weeks postoperatively (p = 0.30). In univariate analysis, non-white race (odds ratio [OR] 5.36, 95% CI 1.16-24.73) and diabetes (OR 2.80, 95% CI 1.26-6.23) were associated with increased risk of UTI. On multivariate analysis, only diabetes remained an independent risk factor. Comparisons between groups were evaluated using two-sample t test for age, Chi-squared tests for diabetes, and Wilcoxon rank sum test for all other variables. CONCLUSION: There was only a 5% difference in 6-week UTI rates between those who received standard vs silver-alloy SPC; the study was not powered to detect such a small difference. Diabetes was identified as a risk factor for SPC-associated UTI in women undergoing pelvic reconstructive surgeries.

The Rise and Fall of Mesh in Pelvic Surgery and the Shortcomings of Medical Device Regulation.

Two U.S. Food and Drug Administration public health warnings regarding the use of mesh in stress incontinence and prolapse repairs have had far-reaching clinical and legal consequences. In this commentary, we explore the drastically distinct results from these mesh-based procedures, which revealed systemic flaws with the medical device approval process across specialties and affected thousands of patients.

Long-term outcomes and predictors of failure after surgery for stage IV apical pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare outcomes after uterosacral ligament suspension (USLS) or sacrocolpopexy for symptomatic stage IV apical pelvic organ prolapse (POP) and evaluate predictors of prolapse recurrence. METHODS: The medical records of patients managed surgically for stage IV apical POP from January 2002 to June 2012 were reviewed. A follow-up survey was sent to these patients. The primary outcome, prolapse recurrence, was defined as recurrence of prolapse symptoms measured by validated questionnaire or surgical retreatment. Survival time free of prolapse recurrence was estimated using the Kaplan-Meier method, and Cox proportional hazards models evaluated factors for an association with recurrence. RESULTS: Of 2633 women treated for POP, 399 (15.2%) had stage IV apical prolapse and were managed with either USLS (n = 355) or sacrocolpopexy (n = 44). Those managed with USLS were significantly older (p < 0.001) and less likely to have a prior hysterectomy (39.7 vs 86.4%; p < 0.001) or prior apical prolapse repair (8.2 38.6%; p < 0.001). Median follow-up was 4.3 years [interquartile range (IQR) 1.1-7.7]. Survival free of recurrence was similar between USLS and sacrocolpopexy (p = 0.43), with 5-year rates of 88.7 and 97.6%, respectively. Younger age [adjusted hazard ratio (aHR) 1.55, 95% confidence interval (CI) 1.12-2.13; p = 0.008] and prior hysterectomy (aHR 2.8, 95% CI 1.39-5.64; p = 0.004) were associated with the risk of prolapse recurrence, whereas type of surgery approached statistical significance (aHR 2.76, 95% CI 0.80-9.60; p = 0.11). CONCLUSIONS: Younger age and history of prior hysterectomy were associated with an increased risk of recurrent prolapse symptoms. Notably, excellent survival free of prolapse recurrence were obtained with both surgical techniques.

Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate 1- and 2-year urinary continence rates after Burch retropubic urethropexy compared with a retropubic midurethral sling for women with urinary incontinence undergoing sacrocolpopexy. METHODS: We conducted a planned secondary analysis of a multicenter, randomized, single-blind trial comparing Burch with a sling that enrolled participants from June 2009 to August 2013. Objective outcome measures of continence were assessed at 1- and 2-year follow-up through office visits and validated questionnaires. Overall continence was defined as a negative stress test, no retreatment for stress incontinence, and no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire, Short Form, score, 0). Stress-specific continence was defined as fulfillment of the first two criteria and no self-reported stress-related incontinence. Primary outcomes were assessed with intention-to-treat and within-protocol analyses. Comparisons between groups were evaluated using χ or Fisher exact test. RESULTS: The two groups were similar in all measured baseline features. Outcome assessments at 2 years were available for 48 of 57 patients (84%) in the sling group and 45 of 56 patients (80%) in the Burch group. With intention-to-treat analysis, the sling group had significantly higher rates of overall continence than the Burch group (49% [28/57] vs 29% [16/56]; 95% CI for absolute risk difference 3.0-38.1; P=.03) at 1- but not 2-year follow-up (47% [27/57] vs 32% [18/56]; 95% CI for absolute risk difference -2.6 to 33.1; P=.10). The sling group had significantly higher rates of stress-specific continence than the Burch group at 1-year (70% [40/57] vs 46% [26/56]; 95% CI for absolute risk difference 6.1-41.4; P=.01) and 2-year (70% [40/57] vs 45% [25/56]; 95% CI for absolute risk difference 7.9-43.2; P=.006) follow-up. No difference was detected in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urgency incontinence, or patient satisfaction. CONCLUSION: Among women with baseline urinary incontinence undergoing sacrocolpopexy, the retropubic midurethral sling resulted in higher stress-specific continence rates than Burch retropubic urethropexy at 1- and 2-year follow-up.