Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up.

BACKGROUND: Fecal incontinence affects 7% to 12% of the US adult population, causing social, financial, and quality of life burdens. OBJECTIVE: The primary aim of this study was to evaluate the efficacy and safety of nonanimal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application. DESIGN: This was a prospective, single-arm, multicenter, observational Food and Drug Administration-mandated postapproval clinical study. SETTINGS: This study was designed and executed by participating centers in 18 hospitals and colorectal health clinics in coordination with the Food and Drug Administration and the study sponsor. PATIENTS: A total of 283 subjects who previously failed conservative therapy were enrolled across 18 US sites. INTERVENTIONS: Participants received 1 to 2 nonanimal stabilized hyaluronic acid/dextranomer treatments. The first treatment occurred within 30 days of baseline, and a second treatment was administered 1 to 3 months after initial treatment if determined necessary by the physician. Subjects were followed through 7 visits over 36 months after last treatment. MAIN OUTCOME MEASURES: Efficacy (as specified by the Food and Drug Administration) was measured as a fecal incontinence reintervention rate of <50% at 36 months. Reintervention included nonanimal stabilized hyaluronic acid/dextranomer re-treatment, surgical interventions, and physical therapy. Safety was measured by device-related adverse events. Secondary end points included Fecal Incontinence Quality of Life Scale and Cleveland Clinic Florida Fecal Incontinence Score. RESULTS: Using a Bayesian estimate, the reintervention rate of the intention-to-treat population (n = 283) was 18.9% (95% CI, 14.0-24.4) at 36 months. At 36 months, the reintervention rate for subjects with complete data (n = 192) was 20.8% (95% CI, 15.1-26.6). Significant improvement ( p < 0.0001) was noted across the Cleveland Clinic Florida Fecal Incontinence Score and Fecal Incontinence Quality of Life subscales at 36 months. Ninety-two device-related adverse events were reported by 15.2% of enrolled patients; most were GI disorders and resolved quickly. There were no serious adverse events. LIMITATIONS: Limitations of the study included a 32% attrition rate and homogeneous patient population (91.8% white; 85.5% female), possibly limiting generalizability. CONCLUSIONS: Nonanimal stabilized hyaluronic acid/dextranomer demonstrated clinically significant, sustained improvement in symptoms and quality of life for fecal incontinence patients without the occurrence of any serious adverse events. See Video Abstract at http://links.lww.com/DCR/B890 . REGISTRATION: ClinicalTrials.gov ; Unique identifier: NCT01647906. EFICACIA Y SEGURIDAD DE UN CIDO HIALURNICO/ DEXTRANMERO ESTABILIZADO DE ORGEN NO ANIMAL PARA MEJORAR LA INCONTINENCIA FECAL UN ESTUDIO CLNICO PROSPECTIVO, MULTICNTRICO Y DE UN SOLO BRAZO CON SEGUIMIENTO DE MESES: ANTECEDENTES:La incontinencia fecal afecta entre el 7 y el 12% de la población adulta de los EE. UU. Y genera cargas sociales, económicas y de calidad de vida.OBJETIVO:Los objetivos principales de este estudio fueron evaluar la eficacia y seguridad del ácido hialurónico/ dextranómero estabilizado de origen no animal durante 36 meses como condición para la solicitud de aprobación posterior a la comercialización.DISEÑO:Este fue un estudio clínico prospectivo, observacional, de un solo brazo, multicéntrico, ordenado por la FDA después de la aprobación.AJUSTES:Este estudio fue diseñado por los investigadores participantes, la FDA y el patrocinador del estudio que gestionó la recopilación de datos.PACIENTES:Un total de 283 sujetos en quienes previamente falló la terapia conservadora se inscribieron en el estudio prospectivo de un solo brazo en 18 sedes de EE. UU. (NCT01647906).INTERVENCIONES:Los participantes recibieron 1-2 tratamientos con ácido hialurónico/ dextranómero estabilizado no animal. El primer tratamiento se dio dentro de los 30 días posteriores al inicio, mientras que un segundo tratamiento se administró 1-3 meses después del tratamiento inicial si el médico lo determinaba necesario. Los sujetos fueron seguidos durante 7 visitas durante 36 meses después del último tratamiento.PRINCIPALES MEDIDAS DE RESULTADO:La eficacia (según especificado por la FDA) se midió como una tasa de reintervención de incontinencia fecal de <50% a los 36 meses. La reintervención incluyó retratamiento con ácido hialurónico/ dextranómero estabilizado no animal, intervenciones quirúrgicas y fisioterapia. La seguridad se midió mediante los eventos adversos relacionados con tratamiento. Los criterios de valoración secundarios incluyeron la escala de calidad de vida de incontinencia fecal y la puntuación de incontinencia fecal de Cleveland Clinic Florida.RESULTADOS:Utilizando una estimación bayesiana, la tasa de reintervención de la población por intención de tratar (n = 283) fue del 18.9% (IC del 95%: 14.0%, 24.4%) a los 36 meses. A los 36 meses, la tasa de reintervención para los sujetos con datos completos (n = 192) fue del 20.8% (IC del 95%: 15.1%, 26.6%). Se observó una mejora significativa (p <0.0001) en las subescalas de la puntuación de incontinencia fecal de la Cleveland Clinic Florida y de la calidad de vida de la incontinencia fecal a los 36 meses. El 15.2% de los pacientes inscritos informaron 92 eventos adversos relacionados con el tratmiento; la mayoría eran trastornos gastrointestinales y se resolvieron rápidamente. No hubo eventos adversos graves.LIMITACIONES:Las limitaciones incluyen una tasa de deserción del 32% y una población de pacientes homogénea (91.8% blancos, 85.5% mujeres), lo que posiblemente limite la generalización.CONCLUSIÓNES:El ácido hialurónico/ dextranómero estabilizado de origen no animal demostró una mejora sostenida y clínicamente significativa de los síntomas y la calidad de vida de los pacientes con incontinencia fecal, sin que se produjeran efectos adversos graves. Consulte el Video Resumen en http://links.lww.com/DCR/B890 . ( Traducción-Dr. Jorge Silva Velazco )Registro: ClinicalTrials.gov número NCT01647906.

Urinary incontinence in women who have undergone bariatric surgery.

INTRODUCTION: Obesity is a known risk factor for urinary incontinence (UI). As bariatric surgery can result in significant and sustainable weight loss, many chronic diseases closely linked to obesity have likewise shown improvement after surgical weight loss. We propose that bariatric surgery may significantly improve obesity-related UI symptoms as well as improve quality of life. METHODS AND PROCEDURES: This is an interim analysis of an ongoing, prospective, single-institution observational study looking at UI in women enrolled in a bariatric surgery program. Participants completed the Pelvic Floor Distress Inventory (PFDI-20), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), King's Health Questionnaire (KHQ), and Patient Global Impression of Improvement (PGI-I). Questionnaires were administered upon enrollment, pre-operatively, and at 3, 6, and 12 months post-operatively. Demographic data were collected at each interval and analyzed with descriptive statistics. RESULTS: At analysis, 108 patients had enrolled in the study and 60% had progressed to surgery. We analyzed the following surveys: enrollment (n = 108), pre-operative (n = 43), 3-month (n = 29), 6-month (n = 26), and 1-year (n = 27). Mean BMI decreased from 49.8 to 31.1 at 1-year. All surveys showed significant improvement in UI symptoms over time. Overall, UI symptoms (PDFI-20) are correlated with BMI at time of survey and %TBWL (p = 0.03, p = 0.019). Additionally, perception of symptom improvement with surgery (PGI-I) improved over time (3-month p = 0.0289, 6-month p = 0.0024, 12-month p = 0.0035). Quality of life related to UI symptoms (KHQ) significantly improved after surgery (p = 0.0047 3-month, p = 0.0042 6-month, p = 0.0165 1-year). CONCLUSIONS: Although the relationship is complex and likely depends on many factors, weight loss after bariatric surgery is associated with improvement in UI symptoms and UI-related quality of life. Bariatric surgery can play a role in the long-term treatment of UI in women with obesity that may negate the need for further invasive UI procedures.

The Correlation Between the Sonographic Course of Transobturator Slings and Sling-Related Pain.

OBJECTIVES: To determine whether transobturator slings follow a consistent path and whether there is an association between ultrasonographically visualized sling pattern or position with sling-related pain. METHODS: This was a cross-sectional retrospective pilot study. We evaluated women who were presented to our clinic for pain or other urogynecologic symptoms following transobturator sling placement between 2009 and 2014. Patients had undergone a 3-dimensional endovaginal pelvic floor ultrasound, assessing minimal levator hiatus, antero-posterior diameter, left-right diameter, and the hiatal shape. The mesh patterns were categorized as seagull patterns (normal), lopsided, flat, and convoluted. RESULTS: A total of 68 cases were reviewed. Fifty patients reported pain, and 18 did not. There were wide variations in the course of the slings. The sling center- minimal levator hiatus position ranged 14.8 mm below and 17.9 mm above the minimal levator hiatus. The lateral arm insertion points ranged between 17.1 mm below and 16.6 mm above the minimal levator hiatus. The right arm insertion points ranged between 9.6 mm below and 18.8 mm above the minimal levator hiatus. Thirty-five of 68 (70%) patients with pain and 13 of 18 (72.2%) without had abnormal sling patterns. The abnormal sling shape was not correlated with pain (P = 1). The levator shape trended toward a statistical significant correlation with sling shape abnormality (P = .084). CONCLUSIONS: This population of women with transobturator sling complications demonstrated wide variations in anatomic paths. Neither the abnormal sling shape nor the distance of the center of the tape from the minimal levator hiatus level were correlated with pain.

Consensus Definitions and Interpretation Templates for Magnetic Resonance Imaging of Defecatory Pelvic Floor Disorders: Proceedings of the Consensus Meeting of the Pelvic Floor Disorders Consortium of the American Society of Colon and Rectal Surgeons, the Society of Abdominal Radiology, the International Continence Society, the American Urogynecologic Society, the International Urogynecological Association, and the Society of Gynecologic Surgeons.

The Pelvic Floor Disorders Consortium (PFDC) is a multidisciplinary organization of colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners. Specialists from these fields are all dedicated to the diagnosis and management of patients with pelvic floor conditions, but they approach, evaluate, and treat such patients with their own unique perspectives given the differences in their respective training. The PFDC was formed to bridge gaps and enable collaboration between these specialties. The goal of the PFDC is to develop and evaluate educational programs, create clinical guidelines and algorithms, and promote high quality of care in this unique patient population. The recommendations included in this article represent the work of the PFDC Working Group on Magnetic Resonance Imaging of Pelvic Floor Disorders (members listed alphabetically in Table 1). The objective was to generate inclusive, rather than prescriptive, guidance for all practitioners, irrespective of discipline, involved in the evaluation and treatment of patients with pelvic floor disorders.

How does 3D endovaginal ultrasound compare to magnetic resonance imaging in the evaluation of levator ani anatomy?

INTRODUCTION AND HYPOTHESIS: To compare magnetic resonance imaging (MRI) to 3D endovaginal ultrasound (EVUS) in the evaluation of major levator ani defects in women with pelvic floor disorders. METHODS: A total of 21 subjects with pelvic floor with complaints of pelvic floor disorders were included in this study. EVUS imaging of the levator ani muscle (LAM) was performed in all subjects, and the LA muscle groups of interest evaluated were the puboanalis (PA), puborectalis (PR), and pubovisceralis (PV) muscles. The right and left subdivisions were evaluated separately, and classified as (i) normal, normal with only minor irregularities, grossly abnormal, or absent, or (ii) by the levator ani deficiency (LAD) score and classified by no defect (complete attachment of muscle to the pubic bone), <50% detachment or loss, >50% detachment or loss, and completely detached or complete muscle loss. Paired data were analyzed with McNemar's test or Bowker's test of symmetry. RESULTS: When unilateral LAM subdivisions were classified as "normal," "normal with minor irregularity," "grossly abnormal," and "absent," there were no significant differences between MRI and EVUS by categorization of LAM defects. Comparing "normal" versus "abnormal," there was no difference between imaging modalities. When compared by LAD score evaluation, there were no differences in the categorization of unilateral defects between MRI and EVUS. CONCLUSIONS: Endovaginal 3D US is comparable to MRI in its ability to identify both normal and abnormal LAM anatomy. Neurourol. Urodynam. 36:409-413, 2017. © 2015 Wiley Periodicals, Inc.

Characteristics associated with pelvic organ prolapse in women with significant levator ani muscle deficiency.

INTRODUCTION AND HYPOTHESIS: Age is a factor associated with symptomatic pelvic organ prolapse (POP) among women with significant levator ani deficiency. METHODS: This cross-sectional study included patients who were referred for varied pelvic floor disorders, had 3D endovaginal ultrasound as part of their evaluation, and were diagnosed with significant levator ani muscle deficiency defined as a score of 12 or more on 3D endovaginal ultrasound. Patients were categorized as having no pelvic organ prolapse (stages 0 and 1), or symptomatic prolapse (stages 2-4). RESULTS: Seventy-six women were available for analysis and found to have significant levator ani muscle deficiency, including 51 with symptomatic POP and 25 without POP. Patients with symptomatic POP were older, (mean age 66 (SD ± 11.8) vs 48 (SD ± 17.3) years; p <0.0001), had greater mean minimal levator hiatus (MLH) area (19.7 cm(2) (SD ± 4.6) vs 17.5 cm(2) (SD ± 3.5); p = 0.048), and were more likely to be menopausal (91.3 % vs 54.5 %; p <0.001) compared with those with no POP. In a modified Poisson regression analysis excluding nulliparous women, increasing age (RR = 2.39, 95 % CI 1.03-5.55) and smoking (RR = 1.34, 95 % CI 1.08-1.67) remained associated with symptomatic POP after controlling for one another and the MLH area. CONCLUSIONS: Among women with significant levator ani deficiency, older women and smokers had an increased prevalence of symptomatic POP. On average, women without POP, but with significant levator ani deficiency were 18 years younger than women with POP and significant muscle deficiency.

Levator plate descent correlates with levator ani muscle deficiency.

AIMS: Measurements such as the minimal levator hiatus dimension, levator plate angle, iliococcygeal angle, and anorectal angle have been used for assessing the impact of levator damage on static and dynamic imaging features. The primary aim of this study was to investigate the association between levator ani muscle deficiency (LAD) and the position of the levator plate. METHODS: 3D endovaginal ultrasounds of 186 women were reviewed. The levator ani muscle groups, the puboanalis, puborectalis, and pubovisceralis, were scored for abnormalities, (0 no defect and 3 total absence of the muscle). The levator plate descent angle, minimal levator hiatus dimensions, and the anorectal angle were measured. Levator plate descent towards the perineum was assessed and correlated with levator ani muscle deficiency. RESULTS: The correlation between puborectalis scores and minimal levator hiatus area, anorectal angle and levator plate descent angle were 0.43 (P < 0.0001), 0.22 (P = 0.0045), and -0.40 (P < 0.0001), respectively. The correlation between pubovisceralis scores and minimal levator hiatus area, anorectal angle and levator plate descent angle were 0.36 (P < 0.0001), 0.38 (P < 0.0001), and -0.40 (P < 0.0001), respectively. The correlation between the total levator ani muscle scores and the minimal levator hiatus area, anorectal angle and the levator plate descent angle were 0.45 (P < 0.0001), 0.31 (P < 0.0001), and -0.45 (P < 0.0001) respectively. CONCLUSION: Worsening LAD score is associated with levator plate descensus and with decreasing levator plate descent angle. We can use levator plate descent angle along with the minimal levator hiatus and anorectal angle as objective measurements to assess levator ani muscle deficiency.

Surgical Care Processing in Major Oklholma City Hosptal: The Surgeons' Perspective.

PURPOSE: This study aimed to assess processing of surgical care provided at major Oklahoma City hospitals based on surgeons'perception. METHODS: A questionnaire was sent out to Oklahoma County Medical Society surgeons using survey monkey to assess surgeons' perception of surgical care provided by major hospitals in Oklahoma City metropolitan area. The email contained a short introduction of study and the general aim of the study. Student t test was applied to compare groups mean. P value <0.05 was considered significant. RESULTS: 79 valid responses were identified. 25% of surgeons scored that their patients waited in the post-op recovery area between 31-60 minutes before they were roomed, with a 90% surgeon satisfaction rate. Compared to the longer waiting times this satisfaction rate was significantly higher (P < 0.0001). 64.6% of surgeons reported 31-60 minutes turn-over time between cases with only an 8% satisfaction rate. 10-30 minutes turnover time was reported in 13.9% of participants with 72.7% satisfaction rate which was significant when compared to the former group. The surgeons scored that their patients presented to the hospital 1-2 hours before surgery 55.7% of the times and 92.7% of the surgeons were satisfied with this process (P < 0.0001). CONCLUSION: Surgeons'satisfaction increases with decreased patients processing times.

Is de novo stress incontinence after sacrocolpopexy related to anatomical changes and surgical approach?

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the relationship between new onset postoperative stress urinary incontinence (SUI) after sacrocolpopexy (SCP) and anatomical change/surgical approach. METHODS: We analyzed a retrospective cohort of patients with negative preoperative testing for SUI who underwent SCP from 2005 to 2012. Our primary outcome was new onset postoperative SUI. Logistic regression was used to examine the relationship among anatomical change, defined as ΔAa, ΔBa, ΔC, and ΔTVL, and surgical approach, categorized as abdominal (ASCP) for open cases and minimally invasive (MISCP) for laparoscopic and robot-assisted cases, and postoperative SUI. RESULTS: Of 795 cases, 33 ASCP (43%) and 44 MISCP (57%) met the inclusion criteria for analysis. New onset SUI was demonstrated by 15 patients (45%) of the ASCP group and 7 patients (15%) of the MISCP group (p = 0.005). New onset SUI was significantly associated with route of SCP and ΔAa (p = 0.006 and p = 0.033 respectively). Controlling for ΔAa, the odds of new onset SUI were 4.4 times higher in the ASCP group compared with the MISCP group (OR 4.37, 95% CI 1.42, 13.48). Controlling for route of SCP, the odds of new onset SUI were 2.2 times higher with moderate ΔAa compared with low ΔAa (OR 2.16 95% CI 1.07, 4.38). The odds of new onset SUI was 4.7 times higher in those with high ΔAa than in those with low ΔAa (OR 4.67 95% CI 1.14, 19.22). ΔBa, ΔC, and ΔTVL were not associated with new onset SUI. CONCLUSIONS: Greater reduction in point Aa and abdominal surgical route are risk factors for new onset postoperative SUI after SCP.

Obstetric laceration repair in the United States: is there a common practice?

OBJECTIVE: To assess practice preferences in the repair of severe obstetric lacerations among obstetrician/gynecologists in the United States. STUDY DESIGN: A survey detailing third and fourth degree laceration repair techniques was distributed to 634 obstetrician/gynecologists from demographically diverse areas of the United States. Categorical outcomes were compared among respondents using chi2 or Fisher's exact test where appropriate. RESULTS: Of the 266 respondents, there were 124 self-reported "experts" (47%) and 106 physicians-in-training (40%). Repair techniques were compared between experts versus nonexperts and trainees versus practicing physicians. There were no significant differences found between either comparison group on the type and size of suture utilized or preferred method of closure for repair. CONCLUSION: There is little variation in the practice pattern of complex laceration repairs among obstetrician-gynecologists in the United States. This commonality should encourage the design of standard teaching models and techniques for physicians in training.

Surgical repair of bilateral levator ani muscles with ultrasound guidance.

Separation of the levator ani muscles from pubic bone is a common major levator trauma that may occur in vaginal delivery and is associated with pelvic floor dysfunctions. We describe a novel ultrasound-guided technique to repair these muscles. A 33-year-old woman presented with a history of difficult vaginal delivery and complaint of numbness and weakness of the vagina. In evaluation, bilateral levator defects were diagnosed by physical examination, three-dimensional endovaginal ultrasound, and magnetic resonance imaging. With ultrasound guidance the detached ends of muscles were tagged and sutured to their insertion points at the pubic bone. The patient's normal anatomy was restored with the return to normal pelvic floor tone. A follow-up ultrasound showed restored levator anatomy at 3 months.

Does age affect visualization of the levator ani in nulliparous women?

INTRODUCTION AND HYPOTHESIS: Our aim was to assess whether differences in the ages of nulliparous women affect: (1) interobserver reliability, and (2) visualization of the levator ani (LA) muscle subdivisions in nulliparous women using 3D endovaginal ultrasound (3D-EVUS). METHODS: This was a cross-sectional study. Community-dwelling nulliparous women ages 21-70 years were recruited. Participants underwent a standard examination and a 3D-EVUS. LA subdivisions of interest included the puboperinealis, puboanalis, pubococcygeus, puborectalis, and ileococcygeus muscles. Each ultrasound (US) volume was scored using a validated scale and assessed by two observers. Defect severity was scored for each muscle from 0 (no defect) to 6 (complete muscle loss). A summed score of the two sides was grouped as normal (0), minor (1-3), or major (4-6). Bias was examined using Bland-Altman plots. Intraclass coefficients were calculated to report agreement of total scores. Spearman's rank correlation was used to evaluate the association between age and LA scores. RESULTS: Eighty nulliparous women were evaluated. Exact agreement for bilateral scoring of each LA subdivision ranged from 82 % to 84 %. Bilateral scoring of the puboperinealis, puborectalis, and ileococcygeus showed moderate to substantial agreement. Bilateral scores of the puboperinealis demonstrated substantial agreement between observers, with an ICC of 0.8 and a mean difference of -0.2 using the Bland-Altman analysis. When women were analyzed by age decade, reader agreement was overall good to excellent. There was no significant correlation between increasing age and total LA muscle scores (r = 0.179, p = 0.113). CONCLUSIONS: Interobserver reliability or visualization of the LA muscle in nulliparous women was not affected by a woman's age.

Evaluation of vaginal cysts and masses by 3-dimensional endovaginal and endoanal sonography.

The purpose of this pictorial essay is to describe the utility of 3-dimensional endovaginal and endoanal sonography in the assessment of vulvovaginal cysts and masses. It is accepted that compared with transabdominal pelvic sonography, transvaginal end-fire sonography provides improved resolution for visualization of female reproductive organs with fewer artifacts. To visualize the structures that are located in or lateral to the vaginal canal, side-fire 3-dimensional endovaginal or endoanal sonography can be used. This special technique has the advantage of maintaining the spatial anatomic relationship of any abnormality in the vagina.

Anterior and posterior compartment 3D endovaginal ultrasound anatomy based on direct histologic comparison.

INTRODUCTION AND HYPOTHESIS: We used direct histologic comparison to validate the use of 3D endovaginal ultrasound (EVUS) as a novel and emerging technology for evaluating the structures found in the anterior and posterior pelvic floor compartments. METHODS: A young nulliparous female pelvis specimen was dissected and histologic slides were prepared by making 8-Micron-thick sagittal cuts. The slides were stained with Mallory trichrome and arranged to form large sections encompassing each anterior and posterior sagittal plane. Healthy nulliparous women underwent 3D EVUS to obtain 3D cubes of the anterior and posterior compartments. Two investigators independently evaluated the anterior and posterior midsagittal structures. The investigators mutually viewed the images and calculated urethral and anal sphincter measurements. RESULTS: Thirty-one nulliparous women underwent 3D EVUS; 77% of the participants were Caucasian, with mean age 31.8 [standard deviation (SD) 5.8] and mean body mass index (BMI) of 28.5 (SD 7.9). The following mean (SD) measurements were obtained: urethral length 36 mm (± 5); striated urogenital sphincter area 0.6 cm(2) (± 0.16); longitudinal and circular smooth muscle area 1.1 cm(2) (± 0.4); urethral complex width 14 mm (± 2); urethral complex area 1.3 cm(2) (± 0.4); internal anal sphincter length 26 mm (± 4); internal anal sphincter thickness 3.2 mm (± 0.8); and rectovaginal septum length 31 mm (± 5). The agreement for visualization of structures was as follows: vesical trigone 96% (κ = 0.65), trigonal ring 94% (κ = 0.8), trigonal plate 84% (κ = 0.6); longitudinal and circular smooth muscle 100%; compressor urethra 97% (κ = 0.85); striated urogenital sphincter 97% (κ = 0.85); rectovaginal septum 100%; internal anal sphincter 100%; external anal sphincter subdivisions 100%. CONCLUSIONS: Three-dimensional EVUS can be used to visualize structures of the anterior and posterior compartments in nullipara.

Randomized trial comparing office flexible to rigid cystoscopy in women.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to compare office rigid cystoscopy (RC) versus flexible cystoscopy (FC) in women. METHODS: This was a prospective randomized trial comparing FC to RC. Aims were to assess 1-week post-procedural complications, compare procedure pain scores, and to assess physician perception of patient discomfort. Pain scores were assessed by visual analogue scale (VAS) and 5-point verbal descriptor scale (VDS). Chi-square was used for categorical comparison and t tests or Wilcoxon test for continuous variables. RESULTS: One hundred women were enrolled. The mean age of participants was 59.7 years (± SD 14.6), and 91 % were Caucasian. This was the first cystoscopy for 86 % of participants. On the 1-week post-procedure questionnaire (85 % response rate), participants in the FC group reported urinary frequency more often than in the RC group (p = 0.041). The FC group reported urgency with urination lasting 1-2 days (p = 0.030) and burning with urination lasting >3 days (p = 0.026), more than the RC group. These symptoms did not persist at 7 days. The duration of the procedure was slightly faster for the FC group (4.6 ± 1.8 min vs 5.7 ± 3.4 min, p = 0.046). Median VAS scores were 0.9 (0.1-2.72) for the FC group and 0.5 (0-2.4) for the RC group (p = 0.505). There were no significant differences between patient or physician perception of pain in either group. CONCLUSIONS: Urinary frequency and duration of urinary burning post procedure occurred more frequently in the FC group, although these symptoms were transient. Both office FC and RC are generally well tolerated in women with overall low morbidity.

Medical student knowledge of global health problems: obstetric fistulas in developing countries.

OBJECTIVE: To evaluate medical students in the United States at several medical schools regarding their knowledge of the global health burden of obstetric fistulas. STUDY DESIGN: A cross-sectional survey was conducted in 8 schools across the United States over a period of 6 months. The survey was composed of 18 questions on epidemiology, pathology, and treatment of fistulas. It was a web-based module accessed through an emailed link. It was sent to 5,103 medical students' email addresses at the 8 institutions once a week for 4 weeks. SPSS paired student t tests was used for statistical analysis. RESULTS: Of the 1,089 students from 8 medical schools that initially began the survey, 965 completed this voluntary and anonymous survey, with a 21% response rate and 19% completion rate. Overall the students averaged 11/18 (60.7%) correct on this survey. The knowledge of obstetric fistula improved, but not significantly, with increasing level of medical school education, with first-year medical students achieving 10/18 (55%) correct and senior medical students achieving 12/18 (67%) correct (p = 0.1). CONCLUSION: U.S. medical students' knowledge of obstetric fistulas in developing countries does not increase significantly over 4 years of medical school education. While this condition presents largely in the developing world, given rapid globalization as well as increased international health experiences for U.S.-trained health professionals,further effort should be placed in improving medical student knowledge of this devastating condition.