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.

The Response of the Urinary Microbiome to Botox.

INTRODUCTION AND HYPOTHESIS: Our objective was to evaluate if botox alters the urinary microbiome of patients with overactive bladder and whether this alteration is predictive of treatment response. METHODS: This multicenter prospective cohort study included 18-89-year-old patients undergoing treatment for overactive bladder with 100 units of botox. Urine samples were collected by straight catheterization on the day of the procedure (S1) and again 4 weeks later (S2). Participants completed the Patient Global Impression of Improvement form at their second visit for dichotomization into responders and nonresponders. The microbiome was sequenced using 16s rRNA sequencing. Wilcoxon signed rank and Wilcoxon rank sum were used to compare the microbiome, whereas chi-square, Wilcoxon rank sum, and the independent t-test were utilized for clinical data. RESULTS: Sixty-eight participants were included in the analysis. The mean relative abundance and prevalence of Beauveria bassiana, Xerocomus chrysenteron, Crinipellis zonata, and Micrococcus luteus were all found to increase between S1 and S2 in responders; whereas in nonresponders the mean relative abundance and prevalence of Pseudomonas fragi were found to decrease. The MRA and prevalence of Weissella cibaria, Acinetobacter johnsonii, and Acinetobacter schindleri were found to be greater in responders than nonresponders at the time of S1. Significant UM differences in the S1 of patients who did (n = 5) and did not go on to develop a post-treatment UTI were noted. CONCLUSIONS: Longitudinal urobiome differences may exist between patients who do and do not respond to botox.

Opioid use following pelvic reconstructive surgery: a predictive calculator.

INTRODUCTION AND HYPOTHESIS: Our objective was to evaluate the amount of opioids used by patients undergoing surgery for pelvic floor disorders and identify risk factors for opioid consumption greater than the median. METHODS: This was a prospective cohort study of 18- to 89-year-old women undergoing major urogynecological surgery between 1 November2020 and 15 October 2021. Subjects completed one preoperative questionnaire ("questionnaire 1") that surveyed factors expected to influence postoperative pain and opioid use. At approximately 1 and 2 weeks following surgery, patients completed two additional questionnaires ("questionnaire 2" and "questionnaire 3") about their pain scores and opioid use. Risk factors for opioid use greater than the median were assessed. Finally, a calculator was created to predict the amount of opioid used at 1 week following surgery. RESULTS: One hundred and ninety patients were included. The median amount of milligram morphine equivalents prescribed was 100 (IQR 100-120), whereas the median amount used by questionnaire 2 was 15 (IQR 0-50) and by questionnaire 3 was 20 (IQR 0-75). On multivariate logistic regression, longer operative time (aOR 1.64 per hour of operative time, 95% CI 1.07-2.58) was associated with using greater than the median opioid consumption at the time of questionnaire 2; whereas for questionnaire 3, a diagnosis of fibromyalgia (aOR=16.9, 95% CI 2.24-362.9) was associated. A preliminary calculator was created using the information collected through questionnaires and chart review. CONCLUSIONS: Patients undergoing surgery for pelvic floor disorders use far fewer opioids than they are prescribed.

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.

Abdominal and vaginal pelvic support with concomitant hysterectomy for uterovaginal pelvic prolapse: a comparative systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: While approximately 225,000 pelvic organ prolapse (POP) surgeries are performed annually in the US, there is no consensus on the optimal route for pelvic support for the initial treatment of uterovaginal prolapse (UVP). Our objective is to compare the outcomes of abdominal sacrocolpopexy (ASC) to vaginal pelvic support (VPS) with either uterosacral ligament suspension (USLS) or sacrospinous ligament fixation (SSF) in combination with hysterectomy for treating apical prolapse. METHODS: A systematic search was performed through March 2021. Studies comparing ASC with VPS for treatment of UVP were included in the review. The primary outcome was the rate of overall anatomic prolapse failure per studies' definition. Secondary outcomes included evaluating isolated recurrent vaginal wall prolapse, postoperative POP-Q points, total vaginal length (TVL), and Pelvic Floor Distress Inventory (PFDI-20) scores. Random effect analyses were generated utilizing R 4.0.2. RESULTS: Out of 4225 total studies, 4 met our inclusion criteria, including 226 patients in the ASC group and 199 patients in the VPS group. ASC was not found to be associated with a higher rate of vaginal wall prolapse recurrence (OR = 0.6; 95% CI = 0.2-2.4; P = 0.33). There was no significant difference between groups for anterior or apical vaginal wall prolapse recurrence (P = 0.58 and P = 0.97, respectively). ASC was associated with significantly longer TVL (mean difference [MD]: 1.01; 95% CI = 0.33-1.70; P = 0.02) and better POP-Q Ba scores [MD = -0.23; 95% CI = -0.37; -0.10; P = 0.01]. CONCLUSIONS: ASC and vaginal pelvic support (either USLS or SSF) have comparable anatomical outcomes. However, weak evidence of a difference in TVL and Ba was found. The strength of the evidence in this study is based on the small number of observational studies. A large, randomized trial is highly warranted.

Perioperative Complications of Laparoscopic versus Open Surgery for Pelvic Inflammatory Disease.

STUDY OBJECTIVE: To compare complications in patients undergoing laparoscopic vs open surgery for acute pelvic inflammatory disease (PID). DESIGN: We performed a retrospective cohort study of patients who underwent surgery for PID, using the American College of Surgeons National Surgical Quality Improvement Program database from 2010 to 2015. Propensity score matching was used to balance baseline characteristics and compare complications in patients who underwent laparoscopic vs open surgery. SETTING: Surgical management of acute PID. PATIENTS: Patients with a preoperative diagnosis of PID were identified using International Classification of Diseases, Ninth Revision, codes. We excluded patients with chronic PID, gynecologic malignancy, and those for whom the surgical route was unknown. INTERVENTIONS: Surgery for acute PID. MEASUREMENTS AND MAIN RESULTS: The study included 367 patients. The mean age was 43.0 ± 11.1 years, body mass index was 30.9 ± 11.2 kg/m2, and American Society of Anesthesiology class was 2 (interquartile range 2-3). Preoperative signs of sepsis were noted in 33.8% of the patients, and septic shock was present in 1.4%. Hysterectomy was performed in 67.6%, oophorectomy in 12.0%, and salpingectomy in 4.6%. Complications were experienced by 114 patients (31.1%), 11 (3.0%) of which were potentially life-threatening. Multivariate logistic regression identified the following to be independently associated with complications: laparoscopy (adjusted odds ratio [aOR] 0.48; 95% confidence interval [CI], 0.3-0.8; p <.01), operative time (aOR 1.01; 95% CI, 1.00-1.01; p <.01), appendectomy (aOR 2.36; 95% CI, 1.0-5.4; p = .04), elevated international normalized ratio (aOR 2.30; 95% CI, 1.3-4.2; p <.01), and low hematocrit level (aOR 2.53; 95% CI, 1.4-4.5; p <.01). Propensity scores were calculated and used to generate a matched cohort of patients who underwent laparoscopic vs open surgery; the groups were similar, with p <.05 for all covariates. After balancing confounding variables, a laparoscopic approach to surgery remained significantly associated with a lower risk of complications (coefficient -0.07; 95% CI, -0.11 to -0.02; p = .008). CONCLUSION: Laparoscopy was associated with lower complication rates than open surgery in this well-matched cohort of patients who underwent surgery for acute PID.

Adjusting to the new reality: Evaluation of early practice pattern adaptations to the COVID-19 pandemic.

OBJECTIVE: We aim to define national practice patterns to assess current clinical practice, anticipated delays and areas of concern that potentially could lead to deviations from the normal standard of care. METHODS: Anonymous surveys were emailed to members of the Society of Gynecologic Oncology (SGO). The spread of COVID-19 and its impact on gynecologic oncology care in terms of alterations to normal treatment patterns and anticipated challenges were assessed. The Wilcoxon rank sum test was performed to determine risk factors for COVID-19 infection. RESULTS: We analyzed the responses of 331 gynecologic oncology providers. COVID-19 is present in 99.1% of surveyed communities with 99.7% reporting mitigation efforts in effect. The infection rate differs significantly between regions (p≪0.001) with the Northeast reporting the highest number of COVID-19 cases. Practice volume has dropped by 61.6% since the start of the pandemic with most cancellations being provider initiated. A majority of responders (52.8%) believed that ovarian cancer will be the most affected cancer by COVID-19. >94% of responders are proceeding with gynecologic cancer surgeries with exception of grade 1, endometrioid endometrial adenocarcinoma (36.3%). Surgical backlog (58.6%), delayed cancer diagnosis (43.2%) and re-establishing normal care with delayed patient (37.8%) were identified as the top 3 challenges after COVID-19 has abated. CONCLUSIONS: COVID-19 is widespread and has radically altered normal practice patterns. Despite COVID-19 related concerns, most gynecologic oncology care is proceeding. However, the steep decline in clinical volume shows there is a large group of patients who are not being diagnosed or are deferring care.

Cystoscopy with antibiotic irrigation during pelvic reconstruction and minimally invasive gynecologic surgery: A double-blind randomized controlled trial.

AIMS: After pelvic reconstructive surgery, the risk of postoperative urinary tract infection (UTI) is significant; intraoperative cystoscopy may contribute to this risk. Intravesical antibiotics are used in the ambulatory setting and may be applied to the surgical arena. Our objective was to evaluate the efficacy of antibiotic irrigation during intraoperative cystoscopy to prevent postoperative UTI. METHODS: This double-blind randomized controlled trial enrolled 216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019. Participants were randomized to cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B + 40 mg neomycin solution in normal saline (antibiotic). Patients and providers who treated UTIs were blinded. The primary outcome was treatment of UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI. χ2 and multivariable logistic regression analyses were performed. RESULTS: We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6%). Mean age was 51.6 years. Groups were well matched in medical comorbidities and surgery type. Primary vaginal surgery was most common (n = 127, 58.8%). Overall, 10.7% of patients developed a postoperative UTI with no difference in incidence between groups: 9.9% of control (n = 11, 95% confidence interval [CI]: 4.0%-16.0%) versus 11.4% of antibiotic subjects (n = 12, 95% CI: 5.0%-18.0%), on χ2 (p = .718) and logistic regression analysis (adjusted odds ratio, 1.3; CI: 0.53-3.16; p = .569). CONCLUSION: When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.

Gene expression in stress urinary incontinence: a systematic review.

INTRODUCTION: A contribution of genetic factors to the development of stress urinary incontinence (SUI) is broadly acknowledged. This study aimed to: (1) provide insight into the genetic pathogenesis of SUI by gathering and synthesizing the available data from studies evaluating differential gene expression in SUI patients and (2) identify possible novel therapeutic targets and leads. METHODS: A systematic literature search was conducted through September 2017 for the concepts of genetics and SUI. Gene networking connections and gene-set functional analyses of the identified genes as differentially expressed in SUI were performed using GeneMANIA software. RESULTS: Of 3019 studies, 4 were included in the final analysis. A total of 13 genes were identified as being differentially expressed in SUI patients. Eleven genes were overexpressed: skin-derived antileukoproteinase (SKALP/elafin), collagen type XVII alpha 1 chain (COL17A1), plakophilin 1 (PKP1), keratin 16 (KRT16), decorin (DCN), biglycan (BGN), protein bicaudal D homolog 2 (BICD2), growth factor receptor-bound protein 2 (GRB2), signal transducer and activator of transcription 3 (STAT3), apolipoprotein E (APOE), and Golgi SNAP receptor complex member 1 (GOSR1), while two genes were underexpressed: fibromodulin (FMOD) and glucocerebrosidase (GBA). GeneMANIA revealed that these genes are involved in intermediate filament cytoskeleton and extracellular matrix organization. CONCLUSION: Many genes are involved in the pathogenesis of SUI. Furthermore, whole-genome studies are warranted to identify these genetic connections. This study lays the groundwork for future research and the development of novel therapies and SUI biomarkers in clinical practice.

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.

National survey of urogynecological practice patterns among United States OB/GYN oral board examinees in different practice settings.

INTRODUCTION AND HYPOTHESIS: The current urogynecological surgical experience of recent OB/GYN graduates in different practice settings is unclear. The aim of this study was to evaluate differences in urogynecological surgical care between private practitioners (PPs) and other generalist OB/GYN oral board examinees. METHODS: A total of 699 OB/GYN oral board examination examinees were administered a survey during board preparatory courses with a 70.7% response rate. The primary outcome was to determine differences in subjective reported performance of urogynecological surgery with and without apical support procedures (female pelvic medicine and reconstructive surgery, FPMRS, ± apical) between PP and generalists in other practice models (academic, managed care, other). Secondary outcomes included urogynecological case list reporting, referral patterns, and residency training. RESULTS: A total of 473 surveys were completed; after excluding subspecialists, 210 surveys were completed by PP and 162 by individuals in other settings. 6.7% of PPs subjectively reported that they perform FPMRS + apical surgery compared with 4.3% of those in other practice settings (p = 0.33). Although 29.2% of PPs reported adequate FPMRS training in residency compared with 39.7% of those in other practice settings (p = 0.04), 53.6% of PPs reported that they refer patients with pelvic organ prolapse (POP), compared with 66.5% of those in other practice settings (p = 0.013). 38.9% of PPs report that they performed POP surgery compared with 27.8% of non-PPs (p = 0.014). CONCLUSIONS: Regardless of practice setting, surgical volumes are low and few general OB/GYN board examinees report that they perform comprehensive FPMRS ± apical support surgery. The practice environment may affect providers' management of patients with pelvic floor disorders.

Sacral neuromodulation treating chronic pelvic pain: a meta-analysis and systematic review of the literature.

INTRODUCTION AND HYPOTHESIS: Sacral neuromodulation (SNM) is gaining popularity as a treatment option for chronic pelvic pain (CPP). Our hypothesis is that SNM is effective in improving CPP. METHODS: A systematic search was conducted through September 2018. Peer-reviewed studies using pre- and postpain intensity scores were selected. The primary outcome was pain improvement on a 10-point visual analog scale (VAS) (adjusted or de novo) in patients with CPP. Secondary outcomes included comparing SNM approaches and etiologies and evaluating lower urinary tract symptoms (LUTS). RESULTS: Fourteen of 2175 studies, evaluating 210 patients, were eligible for further analysis. The overall VAS pain score improvement was significant [weighted mean difference (WMD) -4.34, 95% confidence interval (CI) = -5.22, to-3.64, p < 0.0001)]. Regarding SNM approach, both standard and caudal approaches had significant reduction in pain scores: WMD -4.32, CI 95% = -5.32, to -3.31 (p < 0.001) for the standard approach, compared with WMD -4.63, 95% CI = -6.57 to -2.69 (P < 0.001), for the caudal approach (p = 0.75). While significant improvement in pain was observed both in patients with and without interstitial cystitis/bladder pain syndrome (IC/BPS), the observed improvement was lower in patients with (WMD -4.13, CI 95% -5.36 to -2.90 versus without (WMD -5.72, CI 95% = -6.18, to-5.27) IC/BPS (p = 0.02). SNM was effective in treating voiding symptoms (frequency, urgency, nocturia) associated with IC/BPS (all p < 0.01). CONCLUSIONS: SNM is an effective therapy for CPP in both IC/BSP and non-IC/BSP patients, with better results in non-IC/BSP patients. Outcomes of the antegrade caudal approach were comparable with the standard retrograde approach.

Chlorhexidine-Alcohol Compared with Povidone-Iodine Preoperative Skin Antisepsis for Cesarean Delivery: A Systematic Review and Meta-Analysis.

OBJECTIVE: To compare chlorhexidine-alcohol with povidone-iodine solutions for skin antisepsis prior to cesarean delivery for the prevention of surgical site infection. STUDY DESIGN: Electronic databases MEDLINE, Embase, Scopus, and Clinicaltrials.gov were searched from inception to August 2017. Eligible studies included randomized controlled trials comparing chlorhexidine-alcohol with povidone-iodine skin preparation solutions for women undergoing cesarean delivery. The primary outcome was surgical site infection including superficial or deep wound infection. Meta-analysis was performed, and risk ratios (RRs) with 95% confidence interval (CI) were calculated using the Mantel-Haenszel random effects model. Statistical heterogeneity was assessed using Higgin's I 2. RESULTS: Of 61 abstracts identified in the primary search, four studies (3,059 women) met the eligibility criteria. The risk of surgical site infection was significantly reduced with chlorhexidine-alcohol (RR: 0.72; 95% CI: 0.52-0.98). No heterogeneity across studies was observed with I 2 = 0%. Subgroup analysis of superficial infection only or deep infection only showed no statistically significant difference (RR: 0.76, 95% CI: 0.54-1.08; and RR: 0.50, 95% CI: 0.23-1.10, respectively). CONCLUSION: Preoperative skin cleansing prior to cesarean delivery with chlorhexidine-alcohol reduces surgical site infection as compared with povidone-iodine solutions.

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.

The effect of sacral neuromodulation on pregnancy: a systematic review.

INTRODUCTION AND HYPOTHESIS: To evaluate the effects of sacral neuromodulation (SNM) on pregnancy and the impact of delivery on SNM function. METHODS: A systematic search was conducted through January 2016. We selected studies including women who had SNM and a subsequent pregnancy. RESULTS: Out of 2,316, eight studies were included, comprising 22 patients (26 pregnancies). SNM indications were Fowler's syndrome in 11, urinary retention in 6, fecal incontinence in 1, fecal and urinary urgency in 1, overactive bladder in 1, intractable interstitial cystitis in 1, and myelodysplasia in 1. SNM stayed on in 8 pregnancies. In the remaining 18 pregnancies in which the device was deactivated, 7 had recurrent urinary tract infections, including 1 with pyelonephritis and 2 who requested reactivation owing to recurrent symptoms. Outcomes were reported in 25 pregnancies, 16 had Cesarean section (CS) and 9 had vaginal delivery, including 2 operative deliveries. Out of 25, two infants had pilonidal sinus and motor tic disorder (exhibited at the age of 2 years), both from the same mother. After delivery, SNM was functioning in 15 (60%), 4 required reprogramming, and 3 required replacement (1 had recurrence of fecal incontinence after her operative delivery with evidence of displaced leads and 1 patient reported decreased SNM effects after her two CS), and 3 decided to remove the device (2 out of 3 patients were free of symptoms after SNM deactivation and requested removal). CONCLUSION: Within the current limited evidence, the decision regarding SNM activation or deactivation should be individualized. A registry for those patients is recommended.

Intrapartum factors associated with neonatal hypoxic ischemic encephalopathy: a case-controlled study.

BACKGROUND: Neonatal encephalopathy (NE) affects 2-4/1000 live births with outcomes ranging from negligible neurological deficits to severe neuromuscular dysfunction, cerebral palsy and death. Hypoxic ischemic encephalopathy (HIE) is the sub cohort of NE that appears to be driven by intrapartum events. Our objective was to identify antepartum and intrapartum factors associated with the development of neonatal HIE. METHODS: Hospital databases were searched using relevant diagnosis codes to identify infants with neonatal encephalopathy. Cases were infants with encephalopathy and evidence of intrapartum hypoxia. For each hypoxic ischemic encephalopathy case, four controls were randomly selected from all deliveries that occurred within 6 months of the case. RESULTS: Twenty-six cases met criteria for hypoxic ischemic encephalopathy between 2002 and 2014. In multivariate analysis, meconium-stained amniotic fluid (aOR 12.4, 95% CI 2.1-144.8, p = 0.002), prolonged second stage of labor (aOR 9.5, 95% CI 1.0-135.3, p = 0.042), and the occurrence of a sentinel or acute event (aOR 74.9, 95% CI 11.9-infinity, p < 0.001) were significantly associated with hypoxic ischemic encephalopathy. The presence of a category 3 fetal heart rate tracing in any of the four 15-min segments during the hour prior to delivery (28.0% versus 4.0%, p = 0.002) was more common among hypoxic ischemic encephalopathy cases. CONCLUSION: Prolonged second stage of labor and the presence of meconium-stained amniotic fluid are risk factors for the development of HIE. Close scrutiny should be paid to labors that develop these features especially in the presence of an abnormal fetal heart tracing. Acute events also account for a substantial number of HIE cases and health systems should develop programs that can optimize the response to these emergencies.

Risk Factors, Clinical Presentation, and Outcomes for Abdominal Wall Endometriosis.

STUDY OBJECTIVE: To evaluate the risk factors, presentation, and outcomes in cases of abdominal wall endometriosis. DESIGN: A case-control study (Canadian Task Force classification II-2). SETTING: An academic medical center. PATIENTS: A total of 102 (34 cases and 68 controls) were included. INTERVENTIONS: Surgical resection of abdominal wall endometriosis. MEASUREMENTS AND MAIN RESULTS: Cases underwent surgical excision for abdominal wall endometriosis at Mayo Clinic from January 1, 2000, through December 31, 2013. For each case, 2 controls were randomly selected from a list of women who had surgery in the same year with minimal (American Society for Reproductive Medicine stage I-II) endometriosis. A chart review was completed for variables of interest. Regression models were used to identify independent risk factors associated with abdominal wall endometriosis. RESULTS: In 14 years, 2539 women had surgery for endometriosis at Mayo Clinic. Of these, only 34 (1.34%) had abdominal wall endometriosis. The mean age was 35.2 ± 5.9 years, and the median parity was 2 (range, 0-5). Clinical examination diagnosed abdominal wall endometriosis in 41% of cases, with the cesarean delivery scar being the most common site (59%). There was a strong correlation between the size of the lesion on clinical examination compared with the size of the pathology specimen (r2 = 0.74, p < .001). When compared with controls, cases had significantly higher parity and body mass index, more cyclic localized abdominal pain, less dysmenorrhea, longer duration from the start of symptoms to surgery, and more gynecologic surgeries for symptoms without cure. In the final multivariable model, cyclic localized abdominal pain, absence of dysmenorrhea, and previous laparotomy were independently associated with abdominal wall endometriosis with adjusted odds ratios of 10.6 (95% CI 1.85-104.4, p < .001), 12.4 (95% CI 1.64-147.1, p < .001), and 70.1 (95% CI 14.8-597.7, p < .001), respectively, with an area under the curve for the receiver operating characteristic of 0.94 (95% CI, 0.87-0.98). After excision of the disease, repeat surgery was needed in 2 (5.9%) patients with a median time to recurrence of 50.5 (range, 36-65) months. CONCLUSIONS: Abdominal wall endometriosis is a rare but unique form of endometriosis. Careful history and clinical examination can provide accurate diagnosis and avoid unnecessary delay before surgical intervention. Localized cyclic abdominal pain with the absence of dysmenorrhea and a history of prior laparotomy are independent risk factors with very high accuracy for diagnosis.

Loop Electrosurgical Excision Procedure Instead of Cold-Knife Conization for Cervical Intraepithelial Neoplasia in Women With Unsatisfactory Colposcopic Examinations: A Systematic Review and Meta-Analysis.

OBJECTIVES: This meta-analysis compared loop electrosurgical excision procedure (LEEP) with cold-knife conization (CKC) for treating cervical intraepithelial neoplasia (CIN) in patients with unsatisfactory colposcopic examinations. MATERIAL AND METHODS: A literature search on MEDLINE, EMBASE, Cochrane Systematic Reviews, CENTRAL, Web of Science, and Scopus databases was conducted from inception until April 2015. We included clinical trials and cohort studies comparing CKC with LEEP for treating CIN. The primary outcome was a combined end point of persistent CIN (<6 months after conization) and recurrent CIN (>6 months). Secondary outcomes included procedural, pathologic, and long-term outcomes. Pooled relative risk (RR) and weighted mean difference (WMD) were used to report binary and continuous outcomes, respectively. RESULTS: Among 26 studies, the incidence of persistent and recurrent disease after LEEP was comparable with that after CKC (15.6% vs 7.38%; RR = 1.35; 95% CI = 1.00-1.81). Loop electrosurgical excision procedure was faster, caused less intraoperative bleeding, and resulted in shorter hospital stay (WMD, 9.5 minutes [95% CI = 6.4-12.6 minutes]; WMD, 42.4 mL [95% CI = 21.3-106 mL]; and WMD, 1.5 days [95% CI = 1.1-1.8 days], respectively). Loop electrosurgical excision procedure cones were shallower with overall less volume and weight than CKC (WMD, 5.1 mm [95% CI = 3.2-7.1 mm]; 2.6 mm [95% CI = 0.6-5.7 mm]; and 2.6 g [95% CI = 1.4-3.7 g], respectively). During follow-up, LEEP was associated with less cervical stenosis and fewer unsatisfactory examinations; however, this was not statistically significant (RR, 0.5 [95% CI = 0.1-1.5]; RR, 0.7 [95% CI = 0.4-1.2], respectively). CONCLUSIONS: Loop electrosurgical excision procedure is an acceptable alternative to CKC in women with CIN and unsatisfactory colposcopic examinations. Close follow-up is necessary for prompt detection and treatment of persistent or recurrent disease.

Impact of a labor and delivery safety bundle on a modified adverse outcomes index.

BACKGROUND: The Obstetrics Adverse Outcomes Index was designed to measure the quality of perinatal care and includes 10 adverse events that may occur at or around the time of delivery. We hypothesized that adverse outcomes in the labor and delivery suite, including hypoxic ischemic encephalopathy, could be decreased with a combination of interventions, even among high-risk pregnancies. OBJECTIVE: The objective of the study was to evaluate the impact of a labor and delivery care bundle on adverse obstetrics outcomes as measured by a modified Obstetrics Adverse Outcomes Index, Weighted Adverse Outcomes Index, and Severity Index. STUDY DESIGN: This is a retrospective cohort study including all women who delivered at our academic, tertiary care institution over a 3 year period of time, before and after the implementation of an intervention to decrease adverse outcomes. Outcome measures consisted of previously reported indices that were modified including the addition of hypoxic ischemic encephalopathy. The adverse outcomes index is a percentage of deliveries with 1 or more adverse events, the weighted adverse outcomes index is the sum of the points assigned to cases with adverse outcomes divided by the number of deliveries, and the severity index is the sum of the adverse outcome scores divided by the number of deliveries with an identified adverse outcome. A segmented regression analysis was utilized to evaluate the differences in the level and trend of each index before and after our intervention using calendar month as the unit of analysis. RESULTS: During the study period, 5826 deliveries met inclusion criteria. Comparing the pre- and postintervention periods, high-risk pregnancy was more common in the postintervention period (73.5% vs 79.4%, P < .001). Overall, there was a decrease in both the Modified Weighted Adverse Outcomes Index (P = .0497) and the Modified Severity Index (P = 0.01) comparing the pre- and postintervention periods; there was no difference in the Modified Adverse Outcomes Index (P = .43). For low-risk pregnancies, there was no significant difference in the levels for any of the measured indices over the study period (P = .61, P = .41, and P = .34 for the Modified Adverse Outcomes Index, Modified Weighted Adverse Outcomes Index, and Modified Severity Index, respectively). Among the high-risk pregnancies, the monthly Modified Weighted Adverse Outcomes Index decreased by 4.2 ± 1.8 (P = .03). The monthly Modified Severity Index decreased by 53.9 ± 17.7 points from the pre- to the postintervention periods (P = .01) and was < 50% of the predicted Modified Severity Index had the intervention not been implemented. The cesarean delivery rate was increasing prior to the intervention, but the rate was stable after the intervention, and the absolute rate did not differ between the pre- and the postintervention periods (28.4% vs 30.0%, P = .20). CONCLUSION: Overall and for high-risk pregnancies, the implementation of the labor and delivery care bundle had a positive impact on the Modified Weighted Adverse Outcomes Index and Modified Severity Index but not the Modified Adverse Outcomes Index.