Characterization of pentosan polysulfate patients for development of an alert and screening system for ophthalmic monitoring.

OBJECTIVE: Pentosan polysulfate (PPS; ELMIRON, Janssen Pharmaceuticals, Titusville, NJ) is a U.S. Food and Drug Administration-approved oral medication for interstitial cystitis. Numerous reports have been published detailing retinal toxicity with the use of PPS. Studies characterizing this condition are primarily retrospective, and consequently, alert and screening systems need to be developed to actively screen for this disease. The goal of this study was to characterize ophthalmic monitoring trends of a PPS-using patient sample to construct an alert and screening system for monitoring this condition. METHODS: A single-institution retrospective chart review was conducted between January 2005 and November 2020 to characterize PPS use. An electronic medical record (EMR) alert was constructed to trigger based on new PPS prescriptions and renewals offering ophthalmology referral. RESULTS: A total of 1407 PPS users over 15 years was available for characterization, with 1220 (86.7%) being female, the average duration of exposure being 71.2 ± 62.6 months, and the average medication cumulative exposure being 669.7 ± 569.2 g. A total of 151 patients (10.7%) had a recorded visit with an ophthalmologist, with 71 patients (5.0%) having optical coherence tomography imaging. The EMR alert fired for 88 patients over 1 year, with 34 patients (38.6%) either already being screened by an ophthalmologist or having been referred for screening. CONCLUSIONS: An EMR support tool can improve referral rates of PPS maculopathy screening with an ophthalmologist and may serve as an efficient method for longitudinal screening of this condition with the added benefit of informing pentosan polysulfate prescribers about this condition. Effective screening and detection may help determine which patients are at high risk for this condition.

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Gynecologic cancer care in the first year of the COVID-19 pandemic.

OBJECTIVE: To analyze the impact of the early COVID-19 pandemic on the diagnosis and initiation of treatment for patients with gynecologic cancer. METHODS: Patients diagnosed with gynecologic cancer in the National Cancer Database during 2017-2020 were included. For the first aim, incidence rate ratios were calculated to compare gynecologic cancer diagnosis in the first year of the COVID-19 pandemic to the three years prior, and factors associated with a reduction in diagnosis were identified. For the second aim, patients who experienced an 8-week delay in cancer treatment were compared to those who did not. Multivariate logistic regression was used to identify factors associated with treatment delay. Propensity score analysis was utilized to compare the rate of cancer treatment delay in patients who were diagnosed with COVID-19 to those who were not. RESULTS: The incidence rate ratio of being diagnosed with gynecologic cancer in 2020 versus 2017-2019 was 0.90 (95%CI 0.90-0.91). Factors associated with increased risk of missed or delayed diagnosis in 2020 included cervical cancer, earlier cancer stage, younger age, lower levels of medical comorbidity, and lack of health insurance. In 2020, factors associated with treatment delay included COVID-19 diagnosis (aOR 1.50, 95%CI 1.35-1.67), in addition to race and ethnicity, insurance type, comorbidity, cancer stage, and primary site. The risk of treatment delay remained significantly elevated in patients diagnosed with COVID-19 after propensity-score matching. CONCLUSIONS: Gynecologic cancer diagnosis and timely provision of care were negatively impacted during the first year of the COVID-19 pandemic, with certain subgroups at elevated risk.

Pudendal Nerve Block Analgesia at the Time of Vaginal Surgery: A Randomized, Double-Blinded, Sham-Controlled Trial.

IMPORTANCE: Effective opioid-sparing postoperative analgesia requires a multimodal approach. Regional nerve blocks augment pain control in many surgical fields and may be applied to pelvic floor reconstruction. OBJECTIVE: This study aimed to evaluate the impact of pudendal nerve block on postoperative pain control and opioid consumption after vaginal surgery. STUDY DESIGN: In this randomized, double-blind, sham-controlled trial, we enrolled women undergoing pelvic reconstruction, excluding patients with chronic pelvic pain or contraindications to nonnarcotic analgesia. Patients were randomized to transvaginal pudendal nerve block (9 mL 0.25% bupivacaine and 1 mL 40 mg/mL triamcinolone) or sham injection (10 mL normal saline). Primary outcomes were pain scores and opioid requirements. Sixty patients were required to show a 20-mm difference on a 100-mm visual analog scale (VAS). RESULTS: We randomized 71 patients: 36 pudendal block and 35 sham. Groups were well matched in baseline characteristics and surgery type. Prolapse repairs were most common (n = 63 [87.5%]), and there was no difference in anesthetic dose or operative time. Pain scores were equivalent in the postanesthesia care unit (mean VAS, 53.1 [block] vs 56.4 [sham]; P = 0.517) and on postoperative day 4 (mean VAS, 26.7 [block] vs 35.5 [sham]; P = 0.131). On postoperative day 1, the intervention group reported less pain, but this did not meet our 20 mm goal for clinical significance (mean VAS, 29.2 vs 42.5; P = 0.047). A pudendal block was associated with lower opioid consumption at all time points, but this was not statistically significant. CONCLUSIONS: Surgeon-administered pudendal nerve block at the time of vaginal surgery may not significantly improve postoperative pain control or decrease opioid use.

Nonhome Discharge in Patients Undergoing Pelvic Reconstructive Surgery: A National Analysis.

IMPORTANCE: Discharge to home after surgery has been recognized as a determinant of long-term survival and is a common concern in the elderly population. OBJECTIVE: The aim of the study was to determine the incidence and risk factors for nonhome discharge in patients undergoing major surgery for pelvic organ prolapse. STUDY DESIGN: We performed a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program Database from 2010 to 2018. We included patients who underwent sacrocolpopexy, vaginal colpopexy, and colpocleisis. We compared perioperative characteristics in patients who were discharged home versus those who were discharged to a nonhome location. Stepwise backward multivariate logistic regression was then used to control for confounding variables and identify independent predictors of nonhome discharge. RESULTS: A total of 38,012 patients were included in this study, 209 of whom experienced nonhome discharge (0.5%). Independent predictors of nonhome discharge included preoperative weight loss (adjusted odds ratio [aOR], 5.9; 95% confidence interval [CI], 1.3-27.5), dependent health care status (aOR, 5.0; 95% CI, 2.6-9.5), abdominal hysterectomy (aOR, 2.3; 95% CI, 1.4-3.7), American Society of Anesthesiologists class 3 or greater (aOR, 2.0; 95% CI, 1.5-2.7), age (aOR, 1.1; 95% CI, 1.05-1.09), operative time (aOR, 1.005; 95% CI, 1.003-1.006), laparoscopic hysterectomy (aOR, 0.6; 95% CI, 0.4-1.0), and laparoscopic sacrocolpopexy (aOR, 0.5; 95% CI, 0.3-0.8). CONCLUSIONS: In patients undergoing surgery for pelvic organ prolapse, nonhome discharge is associated with various indicators of frailty, including age, health care dependence, and certain comorbidities. An open surgical approach increases the risk of nonhome discharge, while a laparoscopic approach is associated with lower risk.

Predictors of prolonged admission after outpatient female pelvic reconstructive surgery.

OBJECTIVES: This study aimed to determine factors associated with prolonged hospital admission following outpatient female pelvic reconstructive surgery (FPRS) and associated adverse clinical outcomes. METHODS: Using the National Surgical Quality Improvement Program database, we identified outpatient FPRS performed 2011-2016. Isolated hysterectomy without concurrent prolapse repair was excluded. Surgeries were classified as major or minor for analysis. The primary outcome was prolonged length of stay (LOS), defined as admission of ≥2 days. Secondary outcomes included complications, readmission and reoperation associated with prolonged LOS. We abstracted data on covariates, and following univariable analysis, performed backward stepwise regression analysis. RESULTS: A total of 29645 women were included: 12311 (41.5%) major and 17334 (58.5%) minor procedures. A total of 6.9% (2033) had a prolonged LOS. On full cohort multivariable regression analysis, patient characteristics associated with prolonged LOS were older age (odds ratio [OR]: 1.1 per 10 years, confidence interval [CI]: 1.06-1.1, p < 0.001), frailty (OR: 1.8, 95% CI: 1.3-2.6, p = 0.001), and Caucasian race (OR: 1.2, CI: 1.02-1.3, p = 0.024). Associated surgical factors included having a major surgical procedure (OR: 1.3, CI: 1.2-1.4, p < 0.001), use of general anesthesia (OR: 2.0, CI: 1.5-2.6, p < 0.001) and longer operative time (OR: 2.0, CI: 1.8-2.2, p < 0.001). The occurrence of any complication (10.3% vs. 4.7%, p < 0.001), hospital readmission (4.3% vs. 1.7%, p < 0.001), and reoperation (2.7% vs. 1.0%, p < 0.001) were more likely with prolonged LOS. CONCLUSIONS: After outpatient FPRS, 6.9% of patients experience an admission of ≥2 days. Prolonged LOS is more common in patients who are older, frail and Caucasian, and in those who have major surgery with long operative time and general anesthesia.

Racial and ethnic disparities in surgical care for endometriosis across the United States.

BACKGROUND: Despite an estimated 10% prevalence of endometriosis among reproductive-age women, surgical population-based data are limited. OBJECTIVE: We sought to investigate racial and ethnic disparities in surgical interventions and complications among patients undergoing endometriosis surgery across the United States. STUDY DESIGN: We performed a retrospective cohort study of American College of Surgeons National Surgical Quality Improvement Program data from 2010 to 2018 identifying International Classification of Diseases, Ninth/Tenth Revision codes for endometriosis We compared procedures, surgical routes (laparoscopy vs laparotomy), and 30-day postoperative complications by race and ethnicity. RESULTS: We identified 11,936 patients who underwent surgery for endometriosis (65% White, 8.2% Hispanic, 7.3% Black or African American, 6.2% Asian, 1.0% Native Hawaiian or Pacific Islander, 0.6% American Indian or Alaska Native, and 11.5% of unknown race). Perioperative complications occurred in 9.6% of cases. After adjusting for confounders, being Hispanic (adjusted odds ratio, 1.31; 95% confidence interval, 1.06-1.64), Black or African American (adjusted odds ratio, 1.71; confidence interval, 1.39-2.10), Native Hawaiian or Pacific Islander (adjusted odds ratio, 2.08; confidence interval, 1.28-3.37), or American Indian or Alaska Native (adjusted odds ratio, 2.34; confidence interval, 1.32-4.17) was associated with surgical complications. Hysterectomies among Hispanic (adjusted odds ratio, 1.68; confidence interval, 1.38-2.06), Black or African American (adjusted odds ratio, 1.77; confidence interval, 1.43-2.18), Asian (adjusted odds ratio, 1.87; confidence interval, 1.43-2.46), Native Hawaiian or Pacific Islander (adjusted odds ratio, 4.16; confidence interval, 2.14-8.10), and patients of unknown race or ethnicity (adjusted odds ratio, 2.07; confidence interval, 1.75-2.47) were more likely to be open. Being Hispanic (adjusted odds ratio, 1.64; confidence interval, 1.16-2.30) or Black or African American (adjusted odds ratio, 2.64; confidence interval, 1.95-3.58) was also associated with receipt of laparotomy for nonhysterectomy procedures. The likelihood of undergoing oophorectomy was increased for Hispanic and Black women (adjusted odds ratio, 2.57; confidence interval, 1.96-3.37 and adjusted odds ratio, 2.06; confidence interval, 1.51-2.80, respectively), especially at younger ages. CONCLUSION: Race and ethnicity were independently associated with surgical care for endometriosis, with elevated complication rates experienced by Hispanic, Black or African American, Native Hawaiian or Pacific Islander, and American Indian or Alaska Native patients.

Pelvic Organ Prolapse Surgery in the Elderly and Frail: Safety of a Reconstructive Versus Obliterative Approach.

OBJECTIVES: The aim of this study was to compare the risk of complications associated with obliterative surgery versus reconstructive surgery in elderly and frail patients undergoing surgery for pelvic organ prolapse. METHODS: We performed a retrospective cohort study utilizing the American College of Surgeons National Surgical Quality Improvement Program Database from 2010 to 2017. We compared characteristics and perioperative complications in patients aged 80 years or older who underwent obliterative surgery versus reconstructive surgery. Multivariate logistic regression and propensity score matching were used to control for confounding. A subanalysis was performed that included patients who were considered frail as defined by the National Surgical Quality Improvement Program Modified Frailty Index 5. RESULTS: Of 1,654 total patients, reconstructive surgery was performed in 56.9% of patients, and obliterative surgery was performed in 43.1%. The respective composite complication rates were 9.2% and 9.8% (P = 0.69), whereas severe complications were experienced by 1.9% in the reconstructive group versus 0.8% in the obliterative group (P = 0.07). On multivariate logistic regression, reconstructive surgery was not significantly associated with the composite complication rate (adjusted odds ratio, 1.0; 95% confidence interval, 0.7-1.4; P = 0.80). After propensity score matching, composite complications did not differ between groups, but the rate of severe complications was significantly higher in patients who underwent reconstructive surgery compared with obliterative surgery (2.1% vs 0.8%; odds ratio, 2.53; 95% confidence interval, 1.01-6.36; P = 0.05). In frail patients only, complication rates did not differ between groups. CONCLUSIONS: In patients aged 80 years or older, the overall rate of complications did not differ between those who underwent reconstructive surgery versus obliterative surgery. However, propensity score matching identified an increased risk of the most severe complications in patients who underwent reconstructive surgery.

Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial.

BACKGROUND: Postoperative urinary retention is common after female pelvic reconstructive surgery. Alpha receptor antagonists can improve dysfunctional voiding by relaxing the bladder outlet and may be effective in reducing the risk of postoperative urinary retention. OBJECTIVE: This study aimed to determine whether tamsulosin is effective in preventing postoperative urinary retention in women undergoing surgery for pelvic organ prolapse. STUDY DESIGN: This was a multicenter, double-blind, randomized controlled trial between August 2018 and June 2020, including women undergoing surgery for pelvic organ prolapse. Patients were excluded from recruitment if they had elevated preoperative postvoid residual volume, history of postoperative urinary retention, or a contraindication to tamsulosin. Those who experienced cystotomy were excluded from analysis. Participants were randomized to a 10-day perioperative course of tamsulosin 0.4 mg vs placebo, beginning 3 days before surgery. A standardized voiding trial was performed on postoperative day 1. The primary outcome was the development of postoperative urinary retention, as defined by the failure of the voiding trial or subsequent need for catheterization to empty the bladder. Secondary outcomes included the rate of urinary tract infection and the impact on lower urinary tract symptoms as measured by the American Urological Association Symptom Index. RESULTS: Of 119 patients, 57 received tamsulosin and 62 received placebo. Groups were similar in regard to demographics, preoperative prolapse and voiding characteristics, and surgical details. Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ratio, 0.28; 95% confidence interval, 0.09-81; P=.02). The number needed to treat to prevent 1 case of postoperative urinary retention was 5.9 patients. The rate of urinary tract infection did not differ between groups. American Urological Association Symptom Index scores significantly improved after surgery in both groups (median total score, 14 vs 7; P<.01). Scores related to urinary stream improved more in the tamsulosin group than in placebo (P=.03). CONCLUSION: In this placebo-controlled trial, tamsulosin use was associated with a reduced risk of postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.

Perioperative outcomes of reconstructive surgery for apical prolapse in the very elderly: a national contemporary analysis.

INTRODUCTION AND HYPOTHESIS: It is predicted that the number of women aged 80 years or older will more than triple by 2050. In the US, women have a 13% lifetime risk of undergoing pelvic organ prolapse surgery. Our aim was to compare the perioperative outcomes following various reconstructive approaches for apical prolapse surgery in the very elderly. METHODS: The National Surgical Quality Improvement Program database was used to identify women age ≥ 80 years of age who underwent reconstructive apical prolapse surgery from 2010 to 2017. Perioperative morbidity of vaginal colpopexy, minimally invasive sacrocolpopexy (MISC) and abdominal sacrocolpopexy (ASC) were compared. The primary outcome was the rate of composite serious complications. Univariate and multivariate logistic regression was used to identify independent predictors of serious complications. RESULTS: A total of 1012 patients were identified: vaginal (n = 792), MISC (n = 151) and ASC (n = 69). The composite serious complication rate was higher in the ASC group compared to vaginal/MISC groups (18.8% vs. 9.3% and 9.3%, p < 0.05). ASC had higher rates of blood transfusion, thromboembolism and reintubation. Life-threatening complications, readmission, pneumonia, stroke and 30-day mortality were lowest in the vaginal group. ASC (aOR 2.27), age > 85 years (aOR 1.98), operative time > 3 h (aOR 2.02), baseline dyspnea (aOR 2.17), "other race" (aOR 2.04), preoperative coagulopathy (aOR 2.92) and ASA (aOR 1.47) were associated with composite serious complications. CONCLUSION: ASC is associated with higher perioperative morbidity in the very elderly population. MISC and vaginal colpopexy have similar rates of composite serious complications; however, vaginal colpopexy is overall the safest approach in this population.

Factors Influencing Selection of Concomitant Total Versus Supracervical Hysterectomy at the Time of Sacrocolpopexy and Associated Perioperative Outcomes.

OBJECTIVES: The objective of this study was to describe national practice patterns of hysterectomy type performed with concurrent sacrocolpopexy and determine clinical factors associated with surgical route. METHODS: We used the National Surgical Quality Improvement Program database with hysterectomy data for this retrospective cohort study. We identified sacrocolpopexy cases from 2014 to 2016 with concurrent hysterectomy and stratified patients into supracervical hysterectomy (SCH) or total hysterectomy (TH). As a secondary analysis, we compared the laparoscopic subset of cases. We performed χ2 and backward stepwise logistic regression analyses to identify factors associated with hysterectomy type and compare complication rates. RESULTS: A total of 4,615 women underwent SCP with hysterectomy: 55.8% TH and 44.2% SCH. Mean ± SD age was 56.5 ± 11.7 years. Gynecologists represent 96.3% of surgeons; 51.2% were urogynecologists. Urogynecologists were more likely than generalists to perform SCH (58.4% vs 41.6%, P < 0.001). Total hysterectomy was associated with younger age (adjusted odds ratio [aOR], 0.98 per year [0.97-0.99]), greater uterine weight (aOR, 1.05 per 10 g [1.03-1.06]), and non-Caucasian race (aOR, 0.73 [0.58-0.92]). Complication rates were equivalent between hysterectomy type (SCH, 6.2% vs TH, 6.2%; P = 0.956). Laparoscopy was used for 84.4% of surgical procedures. In this subgroup, TH was associated with greater uterine weight (aOR, 1.06 per 10 g [1.04-1.08]) and younger age (aOR, 0.97 per year [0.96-0.98]). Complication rates were similar (SCH, 5.1% vs TH, 5.0%; P = 0.824). CONCLUSIONS: At the time of sacrocolpopexy, TH is more common than SCH and is associated with younger age and greater uterine weight, although urogynecologists more commonly perform SCH. The overall risk of complications was low and similar between hysterectomy type.

Apical suspension is underutilized for repair of stage IV pelvic organ prolapse: an analysis of national practice patterns in the United States.

INTRODUCTION AND HYPOTHESIS: Support of the vaginal apex is paramount for a durable repair of pelvic organ prolapse (POP). Our aim is to assess national utilization of apical suspension procedures for the surgical treatment of complete POP. We hypothesize that there might be a high rate of apical suspension with advanced prolapse. METHODS: The 2006-2016 National Surgical Quality Improvement Program database was queried for a primary postoperative diagnosis of complete POP. The primary outcome was type of repair. Secondary outcomes included patient characteristics associated with apical suspension or colpocleisis. Procedures were delineated using CPT codes. Chi-squared and multivariate logistic regression analyses were used to evaluate factors associated with repair type. RESULTS: A total of 2,784 women underwent surgery for complete POP with a mean age of 64.6 ± 11.0 years. Overall, 1,300 (46.7%) patients underwent apical suspension: 487 sacrocolpopexies (17.5%), 428 extraperitoneal suspensions (15.4%), and 391 uterosacral suspensions (14.0%). 5.2% (144) underwent colpocleisis, and 47.5% (1,332) of women had a concurrent hysterectomy (CH). With CH, 38.6% (502) had apical suspension or colpocleisis versus 69.5% (940) of post-hysterectomy cases. On logistic regression, CH was inversely associated with apical suspension (adjusted odds ratio [aOR] 0.37, CI 0.32-0.44, p < 0.001). Colpocleisis was associated with older age (aOR 4.9 per 10 years, CI 3.8-6.3, p < 0.001), post-hysterectomy surgery (aOR 0.23, CI 0.1-0.4, p < 0.001 for CH), and higher comorbidity index (OR 1.7, CI 1.1-2.6, p = 0.009). Complication rates are similar with and without apical suspension (8.2% versus 7.0%, p = 0.269). CONCLUSIONS: During surgery for complete POP, an apical suspension procedure is performed in 46.7% of patients and is more common post-hysterectomy.

National Analysis of Perioperative Morbidity of Vaginal Versus Laparoscopic Hysterectomy at the Time of Uterosacral Ligament Suspension.

STUDY OBJECTIVE: The objective of this study was to compare the morbidity of vaginal versus laparoscopic hysterectomy when performed with uterosacral ligament suspension. DESIGN: Retrospective propensity-score matched cohort study. SETTING: American College of Surgeons National Surgical Quality Improvement Program database. PATIENTS: We included all patients who had undergone uterosacral ligament suspension and concurrent total vaginal hysterectomy (TVH-USLS) or total laparoscopic hysterectomy (TLH-USLS) from 2010 to 2015. We excluded those who underwent laparoscopic-assisted vaginal hysterectomy, abdominal hysterectomy, other surgical procedures for apical pelvic organ prolapse, or had gynecologic malignancy. INTERVENTIONS: We compared 30-day complication rates in patients who underwent TVH-USLS versus TLH-USLS in both the total study population and a propensity score matched cohort. MEASUREMENTS AND MAIN RESULTS: The study population consisted of 3,349 patients who underwent TVH-USLS and 484 who underwent TLH-USLS. Patients who underwent TVH-USLS had a significantly higher composite complication rate (11.4% vs 6.4%, odds ratio [OR] 1.9, 1.3-2.8; p <.01) and a higher serious complication rate (5.6% vs 3.1%, OR 1.8, 1.1-3.1; p = .02), which excluded urinary tract infection and superficial surgical site infection. The propensity score analysis was performed, and patients were matched in a 1:1 ratio between the TVH-USLS group and the TLH-USLS group. In the matched cohort, patients who underwent TVH-USLS had a higher composite complication rate than those who underwent TLH-USLS (10.3% vs 6.4%, OR 1.7, 95% confidence interval [CI], 1.1-2.7; p = .04), whereas the rate of serious complications did not differ between the groups (4.3% vs 3.1%, OR 1.4, 95% CI, 0.7-2.8; p = .4). On multivariate logistic regression, TVH-USLS remained an independent predictor of composite complications (adjusted OR 1.6, 95% CI, 1.0-2.6; p = .04) but not serious complications (adjusted OR 1.4, 95% CI, 0.7-2.8; p = .3). CONCLUSION: In this large national cohort, TVH-USLS was associated with a higher composite complication rate than TLH-USLS, largely secondary to an increased rate of urinary tract infection. After matching, the groups had similar rates of serious complications. These data suggest that TLH-USLS should be viewed as a safe alternative to TVH-USLS.

Evaluation of the ACS NSQIP surgical risk calculator in patients undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to evaluate the accuracy of the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) surgical risk calculator in predicting postoperative complications in patients undergoing pelvic organ prolapse surgery. METHODS: We performed a retrospective review of 354 patients who underwent surgery for pelvic organ prolapse from 2013 to 2017 at a single academic institution. Patient medical information and surgical procedure were entered into the calculator to obtain predicted complication rates, which were compared with observed complications. Logistic regression, C-statistic, and Brier score were used to assess the accuracy of the calculator. RESULTS: Of 354 patients included in the analysis, 79.7% were under the age of 75, and 41.5% were classified as American Society of Anesthesiologists class ≥3. The majority of patients underwent robotic sacrocolpopexy (40.7%) or uterosacral ligament suspension (36.4%), followed by colpocleisis, abdominal sacrocolpopexy, and extraperitoneal suspension. Complications were experienced by 100 patients (28.3%). Most common complications were urinary tract infection (n = 57), surgical site infection (n = 42), and readmission (n = 16); other complications were rare. The surgical risk calculator displayed poor predictive ability for experiencing a complication (C-statistic = 0.547, Brier score = 0.25). CONCLUSIONS: The NSQIP surgical risk calculator displayed poor predictive ability in our cohort of patients undergoing surgery for pelvic organ prolapse, suggesting that this tool might have limited clinical applicability to individual patients in this population.

Perioperative Safety of Surgery for Pelvic Organ Prolapse in Elderly and Frail Patients.

OBJECTIVE: To evaluate the effects of old age and frailty on complication rates after surgery for pelvic organ prolapse. METHODS: The American College of Surgeons' National Surgical Quality Improvement Program database was used to identify patients who underwent surgery for prolapse from 2010 to 2017. We compared our control group (45-64 years, index population) to those aged 65-79 years (elderly) and 80 years and older (very elderly). Frailty was assessed using the National Surgical Quality Improvement Program Modified Frailty Index-5. The primary outcome was the composite rate of serious complications and mortality. RESULTS: We analyzed 27,403 patients in the index population, 20,567 in the elderly group, and 3,088 in the very elderly group. The composite rate of serious complications in the index population was 4.5%, compared with 4.7% in the elderly group (odds ratio [OR] 1.0, 95% CI 0.9-1.1) and 9.0% in the very elderly group (OR 2.1, 95% CI 1.8-2.4). Compared with the index group, the very elderly group had notably elevated risks of cardiac complications (OR 11.9, 95% CI 6.2-23.0), stroke (OR 26.6, 95% CI 5.4-131.8), and mortality (OR 39.9, 95% CI 8.6-184.7). On multivariate logistic regression, the only age group independently associated with serious complications was the very elderly group (adjusted odds ratio [aOR] 2.01, 95% CI 1.8-2.3). The Modified Frailty Index-5 score was independently predictive of complications (aOR 1.4, 95% CI 1.1-2.0). Stratified analysis using interaction terms revealed the Modified Frailty Index-5 score to be predictive of complications in the elderly age group (aOR 2.5, 95% CI 1.3-4.6), but not in the very elderly group. CONCLUSION: Serious complications surrounding prolapse surgery increase substantially in the cohort of patients older than 80 years of age, independent of frailty and medical or surgical risk factors.

Apical Suspension Utilization at the Time of Vaginal Hysterectomy for Pelvic Organ Prolapse Varies With Surgeon Specialty.

OBJECTIVE: To evaluate whether utilization of apical suspension procedures at the time of vaginal hysterectomy for pelvic organ prolapse varies with surgeon specialty. METHODS: This was a retrospective cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program database from 2014 to 2016. International Classification of Diseases, Ninth Revision, Clinical Modification with a diagnosis of pelvic organ prolapse who underwent vaginal hysterectomy with any combination of pelvic reconstructive procedures. Propensity score matching using available preoperative clinical data was used to ameliorate selection bias by specialty at a ratio of 1 female pelvic reconstructive surgeon (FPMRS) surgeon to 2 obstetrician-gynecologists (OBG). Descriptive statistics were reported as means with standard deviations. Pairwise analysis using Student t test and Fisher exact test was performed where appropriate. RESULTS: After propensity score matching, there were 901 cases performed by FPMRS and 1802 performed by OBG. The overall utilization rate of apical suspension in the matched cohort was 81.7% for FPMRS and 19.8% for OBG (P < 0.001). Obstetrician-gynecologists were more likely to perform vaginal hysterectomy without apical suspension compared with FPMRS (44.3% vs 5.8%; P < 0.001) and were also more likely to perform nonapical vaginal repair without also performing an apical suspension, (17.7% vs 9.3%, P < 0.001), compared to urogynecologists. On multivariable logistic regression, having surgery performed by FPMRS was the only significant variable associated with an increased likelihood of undergoing apical suspension (adjusted odds ratio, 5.34; 95% confidence interval, 4.48-6.36). CONCLUSIONS: The FPMRS physicians are more likely to perform apical suspension with vaginal hysterectomy for prolapse repair compared with OBG.

Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery.

OBJECTIVE: This study aimed to determine the effect of tamsulosin on postoperative urinary retention in female patients after pelvic reconstructive surgery. METHODS: Data were obtained from a retrospective, matched cohort of female patients who were admitted after pelvic reconstructive surgery at a single academic institution. Patients who received tamsulosin were compared with those who did not at a 1:4 ratio, matched by surgical procedure. Patients were excluded if they were discharged on the day of surgery or if an intraoperative complication necessitated prolonged postoperative bladder drainage. Information on demographics, preoperative diagnoses, prolapse stage, preoperative voiding dysfunction, urodynamic findings, intraoperative details, postoperative complications, and voiding outcomes up to 6 weeks after surgery was gathered. The primary outcome was postoperative urinary retention, defined by failure of an active voiding trial. RESULTS: Patients underwent surgery between January 2016 and March 2018. We identified 35 patients who received tamsulosin and matched to 140 controls. Patients in the tamsulosin group were younger; groups were otherwise similar. Patients who received tamsulosin after surgery were less likely to develop postoperative urinary retention (2.9% vs 24.3%, P = 0.004). After controlling for confounders, multivariable logistic regression identified tamsulosin use as the only independent predictor of postoperative urinary retention with a significant protective effect (odds ratio, 0.09; 95% confidence interval, 0.01-0.67; P = 0.03). CONCLUSIONS: Prophylactic tamsulosin use may be effective in preventing postoperative urinary retention in female patients undergoing pelvic reconstructive surgery.

Adnexectomy at the time of vaginal hysterectomy for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Preoperative counseling about salpingectomy with pelvic surgery is recommended by the American College of Obstetrics and Gynecology for ovarian cancer risk reduction. Our objective was to determine recent practice patterns and patient factors associated with salpingectomy with vaginal hysterectomy (VH) for pelvic organ prolapse (POP) in the USA. We hypothesize that salpingectomy might have become more common in recent years. METHODS: We queried the 2014-2016 National Surgical Quality Improvement Program database for women with a postoperative diagnosis of POP who underwent VH with any combination of pelvic reconstructive procedures. CPT codes do not differentiate salpingectomy from salpingo-oophorectomy, so subjects were stratified by whether concurrent adnexectomy was performed. Chi-squared and multivariate logistic regression analyses were used to evaluate characteristics associated with adnexectomy. Propensity score matching was utilized when evaluating postoperative complication rates. RESULTS: Of 5,344 women who underwent VH, 2019 (37.8%) had adnexectomy. Adnexectomy rate increased from 34.4% in 2014 to 46.8% in 2016 (p < 0.001). Adnexectomy rates of fellowship-trained urogynecologists and general gynecologists were similar (36.0% vs 38.8%, p = 0.197). On logistic regression analysis, patients more likely to undergo adnexectomy were < 65 years old (OR 0.844, CI 0.75-0.95, p = 0.004), had BMI <30 (OR 0.76, CI 0.68-0.86, p < 0.001), and were non-smokers (OR 0.78, CI 0.64-0.95, p = 0.016). Mean operative time was 17 min longer with adnexectomy (145 vs 128 min, p < 0.001). There were no differences in postoperative complications or reoperation rates between groups. CONCLUSIONS: Adnexectomy during VH for POP is safe and increasingly utilized by gynecology surgeons in the USA.

Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial.

BACKGROUND: Postoperative pain control after urogynecological surgery has traditionally been opioid centered with frequent narcotic administration. Few studies have addressed optimal pain control strategies for vaginal pelvic reconstructive surgery that limit opioid use. OBJECTIVE: The objective of the study was to determine whether, ice packs, Tylenol, and Toradol, a novel opioid-sparing multimodal postoperative pain regimen has improved pain control compared with the standard postoperative pain regimen in patients undergoing inpatient vaginal pelvic reconstructive surgery. STUDY DESIGN: This was a multicenter randomized controlled trial of women undergoing vaginal pelvic reconstructive surgery. Patients were randomized to the ice packs, Tylenol, and Toradol postoperative pain regimen or the standard regimen. The ice packs, Tylenol, and Toradol regimen consists of around-the-clock ice packs, around-the-clock oral acetaminophen, around-the-clock intravenous ketorolac, and intravenous hydromorphone for breakthrough pain. The standard regimen consists of as-needed ibuprofen, as-needed acetaminophen/oxycodone, and intravenous hydromorphone for breakthrough pain. The primary outcome was postoperative day 1 pain evaluated the morning after surgery using a visual analog scale. Secondary outcomes included the validated Quality of Recovery Questionnaire, satisfaction scores, inpatient narcotic consumption, outpatient pain medication consumption, and visual analog scale scores at other time intervals. In all, 27 patients in each arm were required to detect a mean difference of 25 mm on a 100 mm visual analog scale (90% power). RESULTS: Thirty patients were randomized to ice packs, Tylenol, and Toradol and 33 to the standard therapy. Patient and surgical demographics were similar. The median morning visual analog scale pain score was lower in the ice packs, Tylenol, and Toradol group (20 mm vs 40 mm, P = .03). Numerical median pain scores were lower at the 96 hour phone call in the ice packs, Tylenol, and Toradol group (2 vs 3, P = .04). Patients randomized to the ICE-T regimen received fewer narcotics (expressed in oral morphine equivalents) from the postanesthesia care unit exit to discharge (2.9 vs 20.4, P < .001) and received fewer narcotics during the entire hospitalization (55.7 vs 91.2, P < .001). At 96 hour follow up, patients in the ice packs, Tylenol, and Toradol group used 4.9 ketorolac tablets compared with 4.6 oxycodone/acetaminophen tablets in the standard group (P = .81); however, ice packs, Tylenol, and Toradol patients required more acetaminophen than ibuprofen by patients in the standard arm (10.7 vs 6.2 tablets, P = .012). There were no differences in Quality of Recovery Questionnaire or satisfaction scores either in the morning after surgery or at 96 hour follow up. CONCLUSION: The ice packs, Tylenol, and Toradol multimodal pain regimen offers improved pain control the morning after surgery and 96 hours postoperatively compared with the standard regimen with no differences in patient satisfaction and quality of recovery. Ice packs, Tylenol, and Toradol can significantly limit postoperative inpatient narcotic use and eliminate outpatient narcotic use in patients undergoing vaginal pelvic reconstructive surgery.

Ventral-onlay buccal mucosal graft urethroplasty for the treatment of female urethral stricture: a step-by-step video for Female Pelvic Reconstructive Surgeons.

INTRODUCTION AND HYPOTHESIS: Female urethral stricture is a relatively uncommon disease. Conservative management with repeated urethral dilation often leads to unsatisfactory results. Although treatment of female urethral stricture with urethral reconstruction using a variety of surgical techniques is a surgical option, female pelvic reconstructive surgeons have limited exposure to these procedures in their training. The purpose of this video is to demonstrate a step-by-step ventral-onlay buccal mucosal graft urethroplasty in a patient with female urethral stricture disease. METHODS: We use a live action surgical video to describe the harvest of a buccal mucosal graft and ventral-onlay urethroplasty. RESULTS: This video provides a step-by-step approach to a ventral urethroplasty using a buccal mucosal graft. It can be used to educate and train those performing female pelvic reconstructive surgery. CONCLUSION: Pelvic surgeons should be familiar with the management of female urethral stricture, including surgical treatment options such as urethral reconstruction. This video may be used to facilitate the reproducibility and comprehension of the ventral urethroplasty procedure.