Neutrophil Gelatinase-Associated Lipocalin Biomarker and Urinary Tract Infections: A Diagnostic Case-Control Study (NUTI Study).

OBJECTIVES: Acute uncomplicated urinary tract infection (UTI) in women is often treated based on symptoms alone. Urinary tract infection symptoms are highly sensitive but lack specificity and result in overuse of antibiotics. We sought to determine if urine neutrophil gelatinase-associated lipocalin (uNGAL) levels in urine can accurately discriminate between UTI and healthy women. METHODS: We recruited adult women aged 18 to 85 years presenting in the ambulatory setting from November 2014 to January 2016. Cases were defined as women with Centers for Disease Control and Prevention-defined UTI symptoms and a positive urine culture of more than 10 organisms/mL on a midstream clean-catch specimen. Women without UTI symptoms were matched by age and menopausal status as control subjects. Exclusion criteria were no UTIs within 8 weeks, urinary tract anomalies, renal disease, pregnancy, or diabetes. Clean-catch urine samples were obtained for measuring uNGAL, prior to antibiotic treatment of cases. We used Mann-Whitney U test to compare the 2 groups. Receiver operating characteristic curves were plotted to compare the performance of uNGAL to established urinary markers. RESULTS: We enrolled 50 UTI cases and 50 control subjects. Urine NGAL levels were higher in the UTI group than in the control subjects (P < 0.0001). Using a cutoff of 23.9 ng/mL, NGAL achieved 98% sensitivity and 100% specificity. The receiver operating characteristic curve had an area under the curve of 0.97 (95% confidence interval, 0.93-1.00), which was significantly high and showed that uNGAL can identify UTI. CONCLUSIONS: Urine NGAL has the potential as a biomarker for diagnosing UTIs in adult women.

Latency to vaginal mesh exposure with mesh placed abdominally versus vaginally in pelvic floor surgery: A retrospective comparative study.

The primary aim was to compare the difference in time to mesh exposure between mesh placed abdominally versus vaginally. This is a retrospective comparative study of patients presented with vaginal mesh exposure between January 2001 and July 2012. This study compares patients who had undergone vaginally placed mesh procedures to those who had had abdominally placed mesh. Kaplan-Meier survival analysis was used to measure the time to mesh exposure. There were 68 patients with mesh exposure in our cohort. Thirty eight patients had undergone vaginal placement of mesh and 30 patients had abdominal mesh. There was a statistically significant difference in time to mesh exposure between abdominal and vaginal meshes (p≤.0001). Mean time to vaginal mesh exposure with abdominal mesh was 59.8 months (95%CI 46.2-73.3) compared to 23 months (95%CI 15.9-30.2) for vaginal mesh. When controlling for age, BMI and surgeon at index surgery, the Hazard Ratio for mesh exposure in our Cox Regression model was 0.53 (95%CI 0.39-0.71) (p ≤.0001). The mean time to vaginal mesh exposure after abdominal mesh was longer compared to the time to exposure with vaginally placed mesh (60 versus 23 months, p ≤.0001). These results support the evolving evidence that mesh exposures can occur many years distant from the procedure and warrant some level of surveillance or provision of warning signs by the providers who perform procedures with mesh.

Tension-Free Vaginal Tape Failure After Robotic Sacrocolpopexy and Tension-Free Vaginal Tape for Concomitant Prolapse and Stress Incontinence.

OBJECTIVE: Evidence of surgical cure with tension free vaginal tape (TVT) is robust for isolated stress urinary incontinence, but rigorous studies investigating combined prolapse and incontinence are lacking. Our study measured cure of stress incontinence in concomitant robotic sacrocolpopexy and retropubic sling (TVT). We hypothesized a higher rate of objective failure as measured by the cough stress test (CST) compared to failures reported in recent randomized trials of TVT in patients without prolapse (aggregate 8% failure). METHODS: Prospective cohort of patients with stress incontinence and prolapse, scheduled for robotic sacrocolpopexy and TVT. Outcomes assessed at 12 months: CST (primary aim), Patient Global Impression of Improvement (PGI-I), Pelvic Floor Distress Inventory, and the Sandvik questionnaire. RESULTS: Sixty-six of 77 subjects (86%) completed follow-up. Average age was 65 years, 96% were white, with mean body mass index of 28.1 kg/m2. Mean parity was 2.7, 50% had a previous hysterectomy. Mean leading edge of prolapse was +2.3 cm. All patients underwent the planned surgery; additionally, 50% underwent hysterectomy and 38% posterior colporrhaphy.The TVT failure (+CST) was 19.7% (95% confidence interval, 11.3%-31.7%; P < 0.001 compared to 8%). Neither preoperative disease severity, nor preoperative prolapse stage affected risk of failure of TVT. Eighty-three percent of the subjects were happy or very happy (PGI-I). However, those with a positive CST (failure) had significantly less satisfaction on PGI-I, UDI-6, and Pelvic Floor Distress Inventory-20. CONCLUSIONS: In this population with advanced prolapse, cure of stress urinary incontinence by TVT in setting of robotic sacrocolpopexy is lower compared to published trials where prolapse is absent. Women are less satisfied when the postoperative CST is positive.

Pelvic Floor and Urinary Distress in Women with Fibromyalgia.

Fibromyalgia (FM) patients were recently found to have more symptom burden from bothersome pelvic pain syndromes that women seeking care for pelvic floor disease at a urogynecology clinic. We sought to further characterize pelvic floor symptoms in a larger sample of FM patients using of validated questionnaires. Female listserv members of the Fibromyalgia Information Foundation completed an online survey of three validated questionnaires: the Pelvic Floor Distress Inventory 20 (PFDI-20), the Pelvic Pain, Urgency and Frequency Questionnaire (PUF), and the Revised Fibromyalgia Impact Questionnaire (FIQR). Scores were characterized using descriptive statistics. Patients (n = 204 with complete data on 177) were on average 52.3 ± 11.4 years with a mean parity of 2.5 ± 1.9. FM severity based on FIQR score (57.2 ± 14.9) positively correlated with PFDI-20 total 159.08 ± 55.2 (r = .34, p < .001) and PUF total 16.54 ± 7 (r = .36, p < .001). Women with FM report significantly bothersome pelvic floor and urinary symptoms. Fibromyalgia management should include evaluation and treatment of pelvic floor disorders recognizing that pelvic distress and urinary symptoms are associated with more severe FM symptoms. Validated questionnaires, like the ones used in this study, are easily incorporated into clinical practice.

Vaginal birth after cesarean: an effective method to reduce cesarean.

Cesarean deliveries represent almost one third of US births. Given that repeat cesarean is the most common single indication for cesarean, trial of labor after cesarean (TOLAC) with subsequent vaginal birth after cesarean (VBAC) is an important mechanism to reduce the overall cesarean rate. The 2010 National Institutes of Health Conference found that one of the biggest barriers to VBAC is the lack of patient access to TOLAC. Many women who currently deliver by repeat cesarean would be candidates for a TOLAC. This manuscript will summarize the evidence on VBAC to help clinicians identify candidates, provide evidence-based counseling, and guide management of TOLAC.

Delayed diagnosis of vascular injury with a retropubic midurethral sling.

BACKGROUND: Retropubic midurethral slings are the mainstay of treatment for female stress urinary incontinence. Complications of this approach may have long-term implications. CASE: A 55-year-old woman underwent tension-free vaginal tape (TVT) placement. Five years later back pain and gross hematuria prompted cystoscopy and diagnosis of bladder mesh erosion. During surgery to remove the mesh, the left arm of the mesh was found to be through the external iliac vein. The right mesh arm traversed the bladder, laterally around the obturator nerve and right iliac vein, exiting through the peritoneal cavity. CONCLUSION: Neurovascular injury is a rare but serious consequence of TVT. Delayed diagnosis is possible. This case highlights the importance of using recognized landmarks and established surgical technique for TVT placement.

Trial of labor and vaginal delivery rates in women with a prior cesarean.

OBJECTIVE: To evaluate evidence on trial of labor (TOL) and vaginal delivery rates in women with a prior cesarean and to understand the characteristics of women offered a trial of labor. DATA SOURCES: MEDLINE, DARE, and Cochrane databases were searched for articles evaluating mode of delivery for women with a prior cesarean delivery published between 1980 and September 2009. STUDY SELECTION: Studies were included if they involved human participants, were in English, conducted in the United States or in developed countries, and if they were rated fair or good base on U.S. Preventive Services Task Force (USPSTF) criteria. DATA EXTRACTION AND SYNTHESIS: The search yielded 3,134 abstracts: 69 full-text papers on TOL and vaginal birth after cesarean (VBAC) rates and 10 on predictors of TOL. The TOL rate in U.S. studies was 58% (95% CI [52, 65]) compared with 64% (95% CI [59, 70]) in non U.S. STUDIES: The TOL rate in the U.S. was 62% (95% CI [57, 66]) for studies completed prior to 1996 and dropped to 44% (95% CI [34, 53]) in studies launched after 1996, p = .016. In U.S. studies, 74% (95% CI [72, 76]) of women who had a TOL delivered vaginally. Women who had a prior vaginal birth or delivered at a large teaching hospital were more likely to be offered a TOL. CONCLUSIONS: Although the TOL rate has dropped since 1996, the rate of vaginal delivery after a TOL has remained constant. Efforts to increase rates of TOL will depend on patients understanding the risks and benefits of both options. Maternity providers are well positioned to provide key education and counseling when patients are not informed of their options.

Mesh erosion in robotic sacrocolpopexy.

OBJECTIVE: This study aimed to compare the incidence of mesh erosion after robotic sacrocolpopexy between women undergoing total and those undergoing supracervical hysterectomy (SH). METHODS: This is a retrospective cohort study of women who underwent sacrocolpopexy and concomitant hysterectomy using the DaVinci surgical robot between May 2007 and December 2010 at 2 sites. Baseline data were gathered before surgery. The primary outcome was mesh erosion identified during 3 months of follow-up. RESULTS: A total of 102 women underwent sacrocolpopexy, of whom 45 were with concomitant SH and 57 were with total hysterectomy (TH). Their mean age was 58 years, mean body mass index was 26.8 kg/m, 98% were white, 6% smoked, and 25% were on systemic hormone replacement therapy. Mean preoperative Ba = +1.4, C = -2.2. These were not different between the 2 groups or by site. Within 3 months of surgery, mesh erosion was diagnosed in 8 women, all of whom had TH. No mesh erosions occurred in the SH group (14% vs 0%). Total hysterectomy mesh erosion rate at site 1 was 37% compared with 3% [corrected] at site 2. Mesh type was the only identifiable difference between sites: self-cut polypropylene at site 1, precut polypropylene at site 2. Two women in the SH had abnormal uterine pathology: 1 endometrial adenocarcinoma and 1 focus of hyperplasia with atypia. CONCLUSIONS: No mesh erosions were associated with SH within the first 3 months. In TH, the graft material used may be a modifiable factor needing further investigation. Unexpected abnormal uterine pathologic diagnosis remains a possibility with SH. Longer-term follow-up and a randomized trial are warranted to answer these questions.

Bladder pain syndrome: a review.

OBJECTIVE: : Bladder pain syndrome (BPS), including the specific variant interstitial cystitis, is a chronic condition characterized by bladder, urethral, and pelvic pain; urinary urgency; and urinary frequency. Bladder pain syndrome poses many clinical challenges: (1) The diagnosis is one of exclusion and is often inappropriately assigned; (2) a wide-range spectrum of symptoms can be noted in the population from minimally affected to debilitated; and (3) the etiology for the disease is unknown, which has made the development of directed therapies problematic. The objective of this article was to review the current theories of etiology of BPS and the diagnosis of BPS and understand treatment options including surgical, complementary, and pharmaceutical.

New insights on vaginal birth after cesarean: can it be predicted?

OBJECTIVE: To evaluate existing vaginal birth after cesarean (VBAC) screening tools and to identify additional factors that may predict VBAC or failed trial of labor. DATA SOURCES: Relevant studies were identified through MEDLINE, Database of Abstracts of Reviews of Effectiveness, and the Cochrane databases (1980-September 2009), and from recent systematic reviews, reference lists, reviews, editorials, web sites, and experts. METHODS OF STUDY SELECTION: Inclusion criteria limited studies to those of humans, written in English, studies conducted in the United States and developed countries, and those rated good or fair quality by the U.S. Preventive Services Task Force criteria. Studies of individual predictors were combined using a random effects model when the estimated odds ratios were comparable across included studies. TABULATION, INTEGRATION, AND RESULTS: We identified 3,134 citations and reviewed 963 papers, of which 203 met inclusion criteria and were quality-rated. Twenty-eight provided evidence on predictors of VBAC and 16 presented information on scored models for predicting VBAC (or failed trial of labor). Six of the 11 scored models for predicting VBAC (or failed trial of labor) were validated by separated dataset, cross-validation, or both. Whereas accuracy remained high across all models for predicting VBAC, with predictive values ranging from 88% to 95%, accuracy for predicting failed trial of labor was low, ranging from 33% to 58%. Individual predictors including Hispanic ethnicity, African-American race, advanced maternal age, no previous vaginal birth history, birth weight heavier than 4 kg, and use of either augmentation or induction were all associated with reduced likelihood of VBAC. CONCLUSION: Current scored models provide reasonable predictability for VBAC, but none provides consistent ability to identify women at risk for failed trial of labor. A scoring model is needed that incorporates known antepartum factors and can be adjusted for current obstetric factors and labor patterns if induction or augmentation is needed. This would allow women and clinicians to better determine individuals most likely to require repeat cesarean delivery.

Vaginal birth after cesarean: new insights.

OBJECTIVES: To synthesize the published literature on vaginal birth after cesarean (VBAC). Specifically, to review the trends and incidence of VBAC, maternal benefits and harms, infant benefits and harms, relevant factors influencing each, and the directions for future research. DATA SOURCES: Relevant studies were identified from multiple searches of MEDLINE; DARE; the Cochrane databases (1966 to September 2009); and from recent systematic reviews, reference lists, reviews, editorials, Web sites, and experts. REVIEW METHODS: Specific inclusion and exclusion criteria were developed to determine study eligibility. The target population includes healthy women of reproductive age, with a singleton gestation, in the U.S. with a prior cesarean who are eligible for a trial of labor (TOL) or elective repeat cesarean delivery (ERCD). All eligible studies were quality rated and data were extracted from good or fair quality studies, entered into tables, summarized descriptively and, when appropriate, pooled for analysis. The primary focus of the report was term pregnancies. However, due to a small number of studies on term pregnancies, general population studies including all gestational ages (GA) were included in appropriate areas. RESULTS: We identified 3,134 citations and reviewed 963 papers for inclusion, of which 203 papers met inclusion and were quality rated. Studies of maternal and infant outcomes reported data based upon actual rather than intended router of delivery. The range for TOL and VBAC rates was large (28-82 percent and 49-87 percent, respectively) with the highest rates being reported in studies outside of the U.S. Predictors of women having a TOL were having a prior vaginal delivery and settings of higher-level care (e.g., tertiary care centers). TOL rates in U.S. studies declined in studies initiated after 1996 from 63 to 47 percent, but the VBAC rate remained unimproved. Hispanic and African American women were less likely than their white counterparts to have a vaginal delivery. Overall rates of maternal harms were low for both TOL and ERCD. While rare for both TOL and ERCD, maternal mortality was significantly increased for ERCD at 13.4 per 100,000 versus 3.8 per 100,000 for TOL. The rates of maternal hysterectomy, hemorrhage, and transfusions did not differ significantly between TOL and ERCD. The rate of uterine rupture for all women with prior cesarean is 3 per 1,000 and the risk was significantly increased with TOL (4.7/1,000 versus 0.3/1,000 ERCD). Six percent of uterine ruptures were associated with perinatal death. No models have been able to accurately predict women who are more likely to deliver by VBAC or to rupture. Women with one prior cesarean delivery and previa had a statistically significant increased risk of adverse events compared with previa patients without a prior cesarean delivery; blood transfusion (15 versus 32.2 percent), hysterectomy (0.7 to 4 percent versus 10 percent), and composite maternal morbidity (15 versus 23-30 percent). Perinatal mortality was significantly increased for TOL at 1.3 per 1,000 versus 0.5 per 1,000 for ERCD. Insufficient data were found on nonmedical factors such as medical liability, economics, hospital staffing, structure and setting, which all appear to be important drivers for VBAC. CONCLUSIONS: Each year 1.5 million childbearing women have cesarean deliveries, and this population continues to increase. This report adds stronger evidence that VBAC is a reasonable and safe choice for the majority of women with prior cesarean. Moreover, there is emerging evidence of serious harms relating to multiple cesareans. Relatively unexamined contextual factors such as medical liability, economics, hospital structure, and staffing may need to be addressed to prioritize VBAC services. There is still no evidence to inform patients, clinicians, or policymakers about the outcomes of intended route of delivery because the evidence is based largely on the actual route of delivery. This inception cohort is the equivalent of intention to treat for randomized controlled trials and this gap in information is critical. A list of future research considerations as prioritized by national experts is also highlighted in this report.

Vaginal birth after cesarean: new insights on maternal and neonatal outcomes.

OBJECTIVE: To systematically review the evidence about maternal and neonatal outcomes relating to vaginal birth after cesarean (VBAC). DATA SOURCES: Relevant studies were identified from multiple searches of MEDLINE, DARE, and the Cochrane databases (1980 to September 2009) and from recent systematic reviews, reference lists, reviews, editorials, Web sites, and experts. METHODS OF STUDY SELECTION: Inclusion criteria limited studies to the English-language and human studies conducted in the United States and developed countries specifically evaluating birth after previous cesarean delivery. Studies focusing on high-risk maternal or neonatal conditions, including breech vaginal delivery, or fewer than 10 patients were excluded. Poor-quality studies were not included in analyses. TABULATION, INTEGRATION, AND RESULTS: We identified 3,134 citations and reviewed 963 articles for inclusion; 203 articles met the inclusion criteria and were quality rated. Overall rates of maternal harms were low for both trial of labor and elective repeat cesarean delivery. Although rare in both elective repeat cesarean delivery and trial of labor, maternal mortality was significantly increased for elective repeat cesarean delivery at 0.013% compared with 0.004% for trial of labor. The rates of maternal hysterectomy, hemorrhage, and transfusions did not differ significantly between trial of labor and elective repeat cesarean delivery. The rate of uterine rupture for all women with prior cesarean was 0.30%, and the risk was significantly increased for trial of labor (0.47% compared with 0.03% for elective repeat cesarean delivery). Perinatal mortality was also significantly increased for trial of labor (0.13% compared with 0.05% for elective repeat cesarean delivery). CONCLUSION: Overall the best evidence suggests that VBAC is a reasonable choice for the majority of women. Adverse outcomes were rare for both elective repeat cesarean delivery and trial of labor. Definitive studies are lacking to identify patients who are at greatest risk for adverse outcomes.

The presacral space and its impact on sacral neuromodulator implantation.

PURPOSE: We describe the presacral space and its potential impact on sacral neuromodulator implantation and bowel injury. MATERIALS AND METHODS: Parasagittal images containing bilateral sacral foramina (S2-S4) were examined on 45 pelvic magnetic resonance images. Images were excluded from analysis if they were poor quality or had any history causing distortion of normal anatomy. We measured the natural angle between the foramina and the dorsal skin to approximate the needle angulation during neuromodulator electrode placement. Using these angles we measured the distance from the skin to any bowel (D1), the skin to the dorsal sacrum (D2) and then calculated the distance from the dorsal sacrum to any bowel (D3). RESULTS: Mean subject age was 45 years (range 19 to 78) and body mass index was 27.9 kg/m(2) (range 18.6 to 56.2). At S3 the mean foraminal angle and D3 were 46 +/- 8.4 degrees and 27.4 +/- 11.7 mm, respectively. Increasing age was moderately correlated to widening D3 at each foramina (r = 0.3, Pearson's p <0.05). Body mass index did not consistently vary with D3 at any foramina. CONCLUSIONS: Our measurements suggest that the presacral space can be expected to be approximately 27 mm at the level of S3 where the neuromodulator electrode is implanted. It is possible to encounter bowel while performing this implantation using standard techniques and equipment. We recommend the standard use of fluoroscopy during placement.

Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence.

OBJECTIVE: This study measured the 10-year risk of reoperation for surgically treated pelvic organ prolapse and urinary incontinence (POPUI) in a community population. STUDY DESIGN: We conducted a prospective cohort analysis of 374 women who were > 20 years old and who underwent surgery for POPUI in 1995. RESULTS: The 10-year reoperation rate was 17% by Kaplan Meier analysis. Previous POPUI surgery at the time of index surgery conferred a hazard ratio of 1.9 (95% CI, 1.1-3.2; P = .018). The abdominal approach was protective against reoperation compared with the vaginal approach (hazard ratio, 0.37; 95% CI, 0.17-0.83; P = .02) With the use of Cox regression, no association was observed for age, vaginal parity, previous hysterectomy, body mass index, prolapse severity, ethnicity, chronic lung disease, smoking, estrogen status, surgical indication, or anatomic compartment. CONCLUSION: A reoperation rate of 17% is unacceptably high and likely represents an underestimate of the true rate. Most of the factors that influence reoperation have not yet been identified.

Validating a clinical measure of levator hiatus size.

OBJECTIVE: We evaluate the interrater reliability of levator hiatus (LH) size and correlate size to other measures of muscle function. STUDY DESIGN: Participants were examined independently by 2 examiners. During maximal contraction of the levator ani, the muscle was assessed by using Brink's scale. The LH was measured in the transverse and sagittal dimensions by digital palpation. The paired t test was used to compare continuous variables and Spearman's coefficient was used for correlations. RESULTS: The mean LH transverse was 4.5 cm and the mean LH sagittal was 3 cm. The inter-rater correlation for the LH transverse measurement was 0.6 (P < .01) and 0.8 (P < .01) for the LH sagittal measurement. The correlations between the LH size and Brink's scale were moderate (correlation coefficient -0.4 to -0.5, P < .01). Eighty-three percent of measurements were within 1 cm. CONCLUSION: This technique for clinical measurement of levator hiatus size shows good interrater reliability.