Development of the multivariate administrative data cystectomy model and its impact on misclassification bias.

BACKGROUND: Misclassification bias (MB) is the deviation of measured from true values due to incorrect case assignment. This study compared MB when cystectomy status was determined using administrative database codes vs. predicted cystectomy probability. METHODS: We identified every primary cystectomy-diversion type at a single hospital 2009-2019. We linked to claims data to measure true association of cystectomy with 30 patient and hospitalization factors. Associations were also measured when cystectomy status was assigned using billing codes and by cystectomy probability from multivariate logistic regression model with covariates from administrative data. MB was the difference between measured and true associations. RESULTS: 500 people underwent cystectomy (0.12% of 428 677 hospitalizations). Sensitivity and positive predictive values for cystectomy codes were 97.1% and 58.6% for incontinent diversions and 100.0% and 48.4% for continent diversions, respectively. The model accurately predicted cystectomy-incontinent diversion (c-statistic [C] 0.999, Integrated Calibration Index [ICI] 0.000) and cystectomy-continent diversion (C:1.000, ICI 0.000) probabilities. MB was significantly lower when model-based predictions was used to impute cystectomy-diversion type status using for both incontinent cystectomy (F = 12.75; p < .0001) and continent cystectomy (F = 11.25; p < .0001). CONCLUSIONS: A model using administrative data accurately returned the probability that cystectomy by diversion type occurred during a hospitalization. Using this model to impute cystectomy status minimized MB. Accuracy of administrative database research can be increased by using probabilistic imputation to determine case status instead of individual codes.

Prevalence and Predictors of Bladder Outlet Obstruction in Women With Chronic Urinary Symptoms and a History of Urethral Sling Surgery.

PURPOSE: The objective of this study is to review patients with chronic urinary symptoms and remote urethral sling surgery to determine the prevalence and predictors of obstruction. MATERIALS AND METHODS: A single-center retrospective review was performed on patients referred with chronic lower urinary tract symptoms (>6 months) and a history of urethral sling surgery. Obstruction was identified by urodynamics using the Blaivas criteria or fluoroscopy. Clinical findings for patients with and without obstruction were compared. Logistic regression was applied to identify predictors of urodynamic obstruction. The need for sling revision and post-revision outcomes were evaluated. RESULTS: In total 105 patients were included, median age 61 years (IQR 19), median time since sling surgery 5.0 years (IQR 8). Sixty percent (63/105) met the definition for obstruction. Patients with obstruction had higher mean detrusor pressure at maximum urinary flow rate (35 vs 19 cm H2O) and lower maximum urinary flow rate (6.0 vs 14 mL/s; P < .05). A tight suburethral band and increased post-void residuals were significantly associated with urodynamic obstruction (P < .05). Fifty-nine (59/105; 56%) patients underwent suburethral sling excision. The incidence of improvement in storage and voiding symptoms at 6 months was 43% and 87%, respectively. At 30 months post-excision, the probability of being incontinence-free was 56% (95% CI 41, 69) and the probability of being free from redo sling surgery was 75% (95% CI 55, 87). CONCLUSIONS: Obstruction is common in patients with chronic urinary symptoms and history of urethral sling surgery. Patients undergoing sling revision should be observed for persistent storage symptoms and recurrent incontinence.

The use of tissue adhesive in management of genitourinary fistulas: a systematic review and case report.

INTRODUCTION AND HYPOTHESIS: Articles are getting published on the use of tissue adhesive for vesicovaginal fistula. The objective is to carry out a systematic review on their effectiveness and complications. METHODS: A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Two reviewers screened abstracts and full-text and extracted data independently. A narrative synthesis was conducted given the heterogeneity of studies. RESULTS: A total of 1032 studies were identified after searching the database, and 14 articles were included in this systematic review. Of the 84 women included, 12 (14.3%) presented failure or recurrence of their fistula tract. The mean time of follow-up was 11.46 months. The average size of the fistula was 1.05 (range 0.1 to 3.9) cm. Most fistulas (81) included were vesicovaginal fistulas. Nine papers reported the usage of fibrin glue in which only three (6.5%) women reported recurrence of the fistula in a delay of 2 weeks to 26 months. The other studies used cyanoacrylate (14 women) and autologous fibrin injection from the patients' blood (31 women). No significant complications were reported. Complications reported were urinary tract infections in 3 women (3.6%), hematuria in 2 women (2.4%), overactive bladder symptoms in 6 women (7.2%) and septic pelvic thrombosis in one woman (1.2%). CONCLUSIONS: Tissue adhesive appears to be a promising alternative for management of urogenital fistulas without reported important complications.

Preoperative anemia and complications after surgery for pelvic organ prolapse: an analysis of the national surgical quality improvement program database.

INTRODUCTION AND HYPOTHESIS: Preoperative anemia is a well-established risk factor for adverse perioperative outcomes in major surgery, but studies exploring complications after pelvic reconstructive surgery are limited. The objective of this study is to examine the impact of preoperative anemia on 30-day adverse outcomes in patients undergoing pelvic organ prolapse surgery. METHODS: A retrospective cohort of women undergoing pelvic organ prolapse surgery was captured from the National Surgery Quality Improvement Program database (2014-2019). The primary outcome was a composite of postoperative medical complications such as pulmonary embolism, acute renal failure, stroke, myocardial infarction, cardiac arrest, deep vein thrombosis, and sepsis. Secondary outcomes included surgical site infection, bleeding requiring blood transfusion, readmission within 7 days of surgery, and return to the operating room within 30 days. Multivariate logistic regression was used to adjust for important pre-specified potential confounders. RESULTS: A total of 50,848 women were included in the analysis and 9.9% (4,579) met the criteria for anemia (hematocrit <36%). Potentially serious medical complications were rare, occurring in only 348 women (0.7%), and were more common among anemic patients (1.1% vs 0.6%, p < 0.001). On multivariate analysis, preoperative anemia was associated with higher odds of both potentially serious medical complications (OR 1.38, 95% CI 1.01-1.88) and returning to the operating room (OR 1.55, 95% CI 1.23-1.94). Anemic patients had a four-fold increase in the odds of requiring a blood transfusion (OR 4.47, 95% CI 3.60-5.56). CONCLUSIONS: Preoperative anemia is associated with an increased risk of adverse postoperative outcomes in women having surgery for pelvic organ prolapse.

Risk Factors for Urologic Injury in Women Undergoing Hysterectomy for Benign Indication.

OBJECTIVE: To investigate risk factors associated with urologic injury in women undergoing hysterectomy for benign indication. METHODS: A retrospective cohort study for the period of 2011-2018 was conducted using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. Women without urologic injury were compared with women with injury. A pre-specified multivariable logistic regression model, controlling for key patient demographic factors and intraoperative variables, was used to assess for surgical factors associated with urologic injury. RESULTS: Among 262 117 women who underwent hysterectomy for benign indication, 1539 (0.6%) sustained urologic injury. On average, patients with urologic injury were younger, had lower body mass index (BMI), and more frequently underwent a transabdominal surgical approach. Patients who underwent total hysterectomy had increased odds of urologic injury than those who underwent subtotal hysterectomy (adjusted OR [aOR] 1.49; 95% confidence interval [CI] 1.21-1.84). Patients with class III obesity had lower odds of injury than patients with normal BMI (aOR 0.64; 95% CI 0.51-0.80). For risk of urologic injury, an interaction was observed between surgical approach and surgical indication. Abdominal compared with laparoscopic approach was associated with urologic injury for women with endometriosis (aOR 2.98; 95% CI 1.99-4.47), pelvic pain (aOR 3.51; 95% CI 1.74-7.08), menstrual disorders (aOR 4.33; 95% CI 1.68-11.1), and fibroids (aOR 2.28; 95% CI 1.72-3.03). Vaginal compared with laparoscopic approach was associated with increased odds of injury for women with menstrual disorders (aOR 7.62; 95% CI 1.37-42.5). CONCLUSION: While the risk of urologic injury during hysterectomy for benign indication is low, the risk is dependent on patient disease factors and surgical approach.

The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: To evaluate the evidence for pathologies underlying stress urinary incontinence (SUI) in women. METHODS: For the data sources, a structured search of the peer-reviewed literature (English language; 1960-April 2020) was conducted using predefined key terms in PubMed and Embase. Google Scholar was also searched. Peer-reviewed manuscripts that reported on anatomical, physiological or functional differences between females with signs and/or symptoms consistent with SUI and a concurrently recruited control group of continent females without any substantive urogynecological symptoms. Of 4629 publications screened, 84 met the inclusion criteria and were retained, among which 24 were included in meta-analyses. RESULTS: Selection bias was moderate to high; < 25% of studies controlled for major confounding variables for SUI (e.g., age, BMI and parity). There was a lack of standardization of methods among studies, and several measurement issues were identified. Results were synthesized qualitatively, and, where possible, random-effects meta-analyses were conducted. Deficits in urethral and bladder neck structure and support, neuromuscular and mechanical function of the striated urethral sphincter (SUS) and levator ani muscles all appear to be associated with SUI. Meta-analyses showed that observed bladder neck dilation and lower functional urethral length, bladder neck support and maximum urethral closure pressures are strong characteristic signs of SUI. CONCLUSION: The pathology of SUI is multifactorial, with strong evidence pointing to bladder neck and urethral incompetence. While there is also evidence of impaired urethral support and levator ani function, standardized approaches to measurement are needed to generate higher levels of evidence.

Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline.

PURPOSE: This document seeks to establish guidance for the evaluation and management of women with recurrent urinary tract infections (rUTI) to prevent inappropriate use of antibiotics, decrease the risk of antibiotic resistance, reduce adverse effects of antibiotic use, provide guidance on antibiotic and non-antibiotic strategies for prevention, and improve clinical outcomes and quality of life by reducing recurrence of urinary tract infection (UTI) events. MATERIALS AND METHODS: The systematic review utilized to inform this guideline was conducted by a methodology team at the Pacific Northwest Evidence-based Practice Center. A research librarian conducted searches in Ovid MEDLINE (1946 to January Week 1 2018), Cochrane Central Register of Controlled Trials (through December 2017) and Embase (through January 16, 2018). An update literature search was conducted on September 20, 2018. RESULTS: When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low). Such evidence-based statements are provided as Strong, Moderate, or Conditional Recommendations. In instances of insufficient evidence, additional guidance is provided as Clinical Principles and Expert Opinions. CONCLUSIONS: Our ability to diagnose, treat, and manage rUTI long-term has evolved due to additional insights into the pathophysiology of rUTI, a new appreciation for the adverse effects of repetitive antimicrobial therapy, rising rates of bacterial antimicrobial resistance (AMR), and better reporting of the natural history and clinical outcomes of acute cystitis and rUTI. As new data continue to emerge in this space, this document will undergo review to ensure continued accuracy.

Antimicrobial peptide LL-37 and its truncated forms, GI-20 and GF-17, exert spermicidal effects and microbicidal activity against Neisseria gonorrhoeae.

STUDY QUESTION: Do the truncated LL-37 peptides, GI-20 and GF-17, have spermicidal activity and microbicidal effects on the sexually transmitted infection (STI) pathogen Neisseria gonorrhoeae with equivalent potency to LL-37? SUMMARY ANSWER: GI-20 and GF-17 exhibited spermicidal effects on both mouse and human sperm as well as microbicidal action on N. gonorrhoeae with the same efficacy as LL-37. WHAT IS KNOWN ALREADY: The antimicrobial peptide LL-37 exerts microbicidal activity against various STI pathogens as well as spermicidal effects on both mouse and human sperm. STUDY DESIGN, SIZE, DURATION: Spermicidal activities of GI-20 and GF-17 were evaluated in vitro in mouse and human sperm and in vivo in mice. Finally, in vitro antimicrobial effects of LL-37, GI-20 and GF-17 on an STI pathogen, N. gonorrhoeae were determined. All experiments were repeated three times or more. In particular, sperm samples from different males were used on each experimental day. PARTICIPANTS/MATERIALS, SETTING, METHODS: The plasma membrane integrity of peptide-treated sperm was assessed by cellular exclusion of Sytox Green, a membrane impermeable fluorescent DNA dye. Successful mouse in vitro fertilization was revealed by the presence of two pronuclei in oocytes following co-incubation with capacitated untreated/peptide-pretreated sperm. Sperm plus each peptide were transcervically injected into female mice and the success of in vivo fertilization was scored by the formation of 2-4 cell embryos 42 h afterward. Reproductive tract tissues of peptide pre-exposed females were then assessed histologically for any damage. Minimal inhibitory/bactericidal concentrations of LL-37, GI-20 and GF-17 on N. gonorrhoeae were determined by a standard method. MAIN RESULTS AND THE ROLE OF CHANCE: Like LL-37, treatment of sperm with GI-20 and GF-17 resulted in dose-dependent increases in sperm plasma membrane permeabilization, reaching the maximum at 18 and 3.6 µM for human and mouse sperm, respectively (P < 0.0001, as compared with untreated sperm). Mouse sperm treated with 3.6 µM GI-20 or GF-17 did not fertilize oocytes either in vitro or in vivo. Moreover, reproductive tract tissues of female mice pre-exposed to 3.6 µM GI-20 or GF-17 remained intact with no lesions, erosions or ulcerations. At 1.8-7.2 µM, LL-37, GI-20 and GF-17 exerted bactericidal effects on N. gonorrhoeae. LARGE SCALE DATA: N/A. LIMITATIONS, REASONS FOR CAUTION: Direct demonstration of the inhibitory effects of GI-20 and GF-17 on human in vitro and in vivo fertilization cannot be performed due to ethical issues. WIDER IMPLICATIONS OF THE FINDINGS: Like LL-37, GI-20 and GF-17 acted as spermicides and microbicides against N. gonorrhoeae, without adverse effects on female reproductive tissues. With lower synthesis costs, GI-20 and GF-17 are attractive peptides for further development into vaginal spermicides/microbicides. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by Canadian Institutes of Health Research (MOP119438 and CCI82413 to N.T.) and NIH (R01 AI105147 to G.W.). There are no competing interests to declare.

A pilot randomized-controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction.

AIMS: To determine the effectiveness of mirabegron in patients with neurogenic lower urinary tract dysfunction. METHODS: Randomized, double-blind, placebo-controlled study. Canadian patients with spinal cord injury (SCI) or multiple sclerosis (MS) with urinary symptoms and incontinence were recruited. Patients were randomized to mirabegron 25 mg (or an identical placebo) for 2 weeks at which point a dose escalation to mirabegron 50 mg (or an identical placebo) was maintained for 8 weeks. Urodynamics were performed before and after treatment. The primary outcome measure was maximum cystometric capacity (MCC). Intention to treat analysis and ANCOVA models (with adjustment for baseline values) were used and marginal means (MM) are reported; P-value <0.05 was considered significant. RESULTS: Sixteen (9 SCI and 7 MS) patients were randomized to mirabegron and 16 (10 SCI and 6 MS) to placebo. At study completion, there was no significant difference in MCC between mirabegron and placebo (MM 305 vs 369 mL, P = 0.20). There was no significant difference in volume at first neurogenic detrusor overactivity (NDO, MM 167 vs 137 mL, P = 0.14) and peak pressure of NDO (MM 69 vs 82 cmH2 O, P = 0.25). There was no significant difference in pad weights or voiding diary parameters. There was a significantly lower symptom burden among those treated with mirabegron (total neurogenic bladder symptom score MM 29 vs 34, P = 0.047). CONCLUSIONS: Among patients with SCI or MS, we demonstrated non-significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.

Patient-targeted websites on overactive bladder: What are our patients reading?

AIMS: Patients often turn to the Internet for information on medical conditions. We sought to evaluate the quality and readability of highly visible websites on overactive bladder (OAB). METHODS: A survey of 42 consecutive patients attending outpatient urogynecology clinics was performed to identify the most commonly used Internet search engines and search terms for information on OAB. The three most commonly used search engines (Google, Bing, and Yahoo!) were then queried using the three most commonly used search terms. The first 20 relevant websites from each search were reviewed. After excluding duplicates, 35 websites were analyzed. Website quality of information on OAB was evaluated using the DISCERN score, JAMA benchmark criteria, and Health on the Net code (HONcode) accreditation status. Readability was assessed using the Simplified Measure of Gobbledygook (SMOG) and Dale-Chall indices. RESULTS: Websites were classified as advertisement/commercial (31%), health portal (29%), professional (26%), patient group (6%), and other (9%). The overall mean DISCERN score was 44 ± 18 (maximum possible score of 80). Three websites (9%) met all four JAMA benchmark criteria. Seventeen percent of websites provided adequate information on content authorship and contributions. Median SMOG and Dale-Chall indices were 9.9 (IQR 9.3-11.2) and 9.0 (IQR 8.1-9.4), respectively. Nine websites (26%) were HONcode certified. CONCLUSIONS: Popular websites on OAB are of low quality, written for a high school to college-level readership, and often lack adequate information to assess the potential for commercial bias. Patients should be cautioned that incomplete and potentially biased information on OAB is prevalent online.

Complications after minimally invasive sacrocolpopexy with and without concomitant incontinence surgery: A National Surgical Quality Improvement Program (NSQIP) database study.

AIMS: To compare surgical complications for patients having minimally invasive sacrocolpopexy (MISCP) with concomitant incontinence procedure, to those having MISCP alone. METHODS: Patients undergoing MISCP with and without a concomitant incontinence procedure between 2006 and 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology codes. The main outcome of interest was a composite of surgical site infection, bleeding requiring blood transfusion, return to the operating room within 30 days, and surgical stay >48 h. Log-binomial regression was used to identify independent risk factors for the outcome and to generate adjusted effect measures for variables of interest. RESULTS: Seven thousand ninety-seven women met the inclusion criteria, of which 2433 (34%) underwent a concomitant incontinence procedure. Patients having incontinence procedures were slightly older (59 ± 11 vs 58 ± 12, P < 0.0001) and had longer total operating time (225 IQR 170-267 vs 184 IQR 120-232 min, P < 0.0001). Pre-operative steroid use, wound class III/IV (vs I/II), and longer operative time were independent predictors of the composite outcome. After adjusting for baseline patient characteristics and co-morbidities, no association was observed between concomitant incontinence procedure and the composite outcome (adjusted RR 0.87, 95%CI 0.65-1.18) but there was an increased likelihood of urinary tract infection (adjusted RR 2.47 95%CI 1.89-3.27). CONCLUSIONS: Despite being associated with a longer operative time, performing an incontinence procedure at the time of MSCIP was not associated with an increased risk of clinically important surgical complications other than urinary tract infection.

Risk Factors for Urinary Tract Infection following Mid Urethral Sling Surgery.

PURPOSE: Mid urethral sling surgery is common. Postoperative urinary tract infection rates vary in the literature and independent risk factors for urinary tract infection are not well defined. We sought to determine the incidence of and risk factors for urinary tract infection following mid urethral sling surgery. MATERIALS AND METHODS: A retrospective cohort of females who underwent sling surgery was captured from the 2006 to 2014 NSQIP® (National Surgical Quality Improvement Program®) database. Exclusion criteria included male gender, nonelective surgery, totally dependent functional status, preoperative infection, prior surgery within 30 days, ASA® (American Society of Anesthesiologists®) Physical Status Classification 4 or greater, concomitant procedure and operative time greater than 60 minutes. The primary outcome was the incidence of urinary tract infection within 30 days of mid urethral sling surgery. Risk factors for urinary tract infection were assessed by examining patient demographic, comorbidity and surgical variables. Logistic regression analyses were performed to estimate the ORs of individual risk factors. Multivariable logistic regression was then performed to adjust for confounding. RESULTS: A total of 9,022 mid urethral sling surgeries were identified. The urinary tract infection incidence was 2.6%. Factors independently associated with an increased infection risk included age greater than 65 years (OR 1.54, 95% CI 1.07-2.22), body mass index greater than 40 kg/m2 (OR 1.89, 95% CI 1.23-2.92) and hospital admission (OR 2.06, 95% CI 1.37-3.11). Mid urethral sling surgery performed by urologists carried a reduced risk of infection compared to the surgery done by gynecologists (OR 0.52, 95% CI 0.40-0.69). CONCLUSIONS: The urinary tract infection risk following mid urethral sling surgery in NSQIP associated hospitals is low. Novel patient and surgical factors for postoperative urinary tract infection have been identified and merit further study.

Urodynamics for clinically suspected obstruction after anti-incontinence surgery in women.

PURPOSE: We determined the usefulness of urodynamics in patients with obstruction secondary to anti-incontinence surgery. MATERIALS AND METHODS: We retrospectively reviewed the records of all procedures performed from January 2001 to June 2011 to relieve obstruction due to anti-incontinence surgery. Patients were excluded from study if they underwent prior procedures to relieve obstruction, followup data were missing or a neurological disorder was present. Patients were grouped into categories before intervention, including urodynamics diagnostic of obstruction vs nondiagnostic urodynamics vs no urodynamics testing. We also separated patients with predominantly storage symptoms and those with incomplete emptying. RESULTS: A total of 71 women were included in analysis. Of 54 women who presented with increased post-void residual urine volume 33 (61%) were diagnosed with obstruction on urodynamics, urodynamics was not diagnostic in 4 (7.4%) and 17 (32%) did not undergo urodynamics preoperatively. All 18 patients with predominantly storage symptoms underwent urodynamics. In patients with incomplete emptying there was no difference between the groups in storage or voiding symptom improvement, overall cure or success according to whether diagnostic urodynamics were or were not done. Of patients with storage symptoms who underwent urodynamics those without evidence of detrusor overactivity had significantly greater storage symptom improvement than those with detrusor overactivity (85.7% vs 53.8%, p = 0.02). CONCLUSIONS: When voiding symptoms or urinary retention is the primary indication for intervention after anti-incontinence surgery, urodynamic findings are not predictive of outcomes after intervention to relieve obstruction. If storage symptoms are the main indication for intervention, urodynamics may be valuable for patient counseling.