Malone Antegrade Continence Enemas vs. Cecostomy vs. Transanal Irrigation-What Is New and How Do We Counsel Our Patients?

PURPOSE OF REVIEW: No gold standard exists for managing neurogenic bowel dysfunction, specifically in individuals with spina bifida. Since the International Children's Continence Society published its consensus document on neurogenic bowel treatment in 2012, an increased focus on why we must manage bowels and how to improve our management has occurred. This review provides updated information for clinicians. RECENT FINDINGS: A surge in research, mostly retrospective, has been conducted on the success and satisfaction of three types of management for neurogenic bowel. All three management techniques have relatively high success rates for fecal continence and satisfaction rates. Selection of which treatment to carry out still is debated among clinicians. Transanal irrigation is a safe and effective management option for neurogenic bowel that does not require surgery. Antegrade enemas can be carried out via cecostomy tube or Malone antegrade continence enema with similar fecal continence outcomes.

Home Urodynamic Pressures and Volume Measurement for the Neurogenic Bladder: Initial Validation Study.

PURPOSE: We evaluated the ability of a bladder pressure/volume diary to identify patients at risk for increased intravesical pressures. MATERIALS AND METHODS: Patients dependent on clean intermittent catheterization used ruler based manometry to measure intravesical pressures before leakage or scheduled drainage at home. We prospectively collected clinical, urodynamic and bladder pressure/volume diary data in patients with spina bifida who were optimized on anticholinergic therapy and clean intermittent catheterization. Measurements were taken with patients in the supine position with relaxed abdominal muscles. We defined increased pressure as detrusor pressure greater than 30 cm water as measured by urodynamics. ROCs were plotted to correlate bladder pressure/volume diary variables with abnormal intravesical pressures, and the most sensitive variable in determining abnormal intravesical pressures was sought as the end point. RESULTS: A total of 30 patients with a mean age of 10 years (range 1 to 20) were included. Home pressures measured at maximal clean intermittent catheterization volume and mean bladder pressure/volume diary pressures were most reliable in predicting urodynamic pressures greater than 30 cm water (AUC 0.93 and 0.87, respectively). Home pressures measured at maximal clean intermittent catheterization volumes less than 20 cm water were associated with normal bladder pressures (less than 30 cm water) on urodynamics, with a sensitivity of 100% and a specificity of 80%. CONCLUSIONS: Home manometry less than 20 cm water provides a reliable measurement of safe pressures. A bladder pressure/volume diary is feasible and can aid in monitoring pressures at home without the additional cost and morbidity of urodynamics. A bladder pressure/volume diary may be a useful tool to help identify patients who would benefit from urodynamic testing.

Prospective evaluation of Peristeen® transanal irrigation system with the validated neurogenic bowel dysfunction score sheet in the pediatric population.

AIMS: To determine the ability of Peristeen® transanal irrigation system to reduce symptoms of neurogenic bowel dysfunction (NBD) in patients using the validated neurogenic bowel dysfunction scoring system for the pediatric population. METHODS: Patients 3-21 years with NBD whose current bowel program was unsuccessful were given the Neurogenic Bowel Dysfunction (NBoDS) score sheet before initiating Peristeen®, and at 2 weeks, 2 months, and 6 months after. All patients were started on Peristeen® with tap water (20 ml/kg) per daily irrigation. Mean and paired t-tests were completed. RESULTS: 24 patients were enrolled and had follow-up. Mean age was 10.5 years (range 3-21 years), 25%, 50%, 25% had thoracic, lumbar and sacral level lesions respectively. Mean NBoDS score at initiation of Peristeen® was 20.21 (±5.56), n = 24. The mean score after two weeks of use was 12.75 (±4.40), n = 24. There was a statistically significant decrease of 7.46 (95%CI, 5.07-9.84) points, t(23) = 6.47, P < 0.0005 after two weeks. There was a statistically significant decrease in their scores from initiation to the 2 month time period of 7.00 (95%CI, 2.18-11.82) points, t(9) = 3.29, P = 0.009. By the sixth month of daily use the mean NBoDS score was 9.67 (n = 12). This was an average decrease of 8.83 (95%CI, 5.39-12.28) points from initiation score, t(11) = 5.641, P < 0.005. CONCLUSION: The Peristeen® transanal irrigation system provides a significant reduction in NBoDS scores in pediatric patients with NBD. Peristeen® should be considered when other conservative bowel management options have been unsuccessful. Neurourol. Urodynam. 36:632-635, 2017. © 2016 Wiley Periodicals, Inc.

Development, reliability and validation of a neurogenic bowel dysfunction score in pediatric patients with spina bifida.

OBJECTIVE: To develop a reliable and valid questionnaire to monitor neurogenic bowel symptoms in children. PATIENTS: Thirty-four children aged 6-18 with neurogenic bowel and their caregivers. Eighteen control patients. METHODS: An expert panel generated a domain of observables and formative/reflective content. Response options were scaled following Likert-type items. Key informant interviews revised the measures. A final questionnaire was given to patients twice to calculate intra-rater reliability using Cohen's Kappa Coefficient (k) and paired t-test. Blinded interviews were conducted after physical examination and health assessment and questionnaires completed by a nurse to determine construct validity and inter-rater reliability using k and Spearman's rank-order correlation. Control patients completed the questionnaire once, their results were used to determine discriminate validity and a receiver operating characteristic (ROC) curve. RESULTS: Intra-rater reliability showed 85% of the questionnaires having k >0.6. Paired t-test results of t(33) = 1.997, P = 0.054, d = 0.53, confirmed there was not a significant difference between the scores of the two completed questionnaires. Inter-rater reliability showed 97% of the questionnaires having k >0.6 between the nurse and the patient/caregiver responses. Scores had a strong positive correlation at rs (32) = 0.943, P < 0.0005. Mean score with neurogenic bowel was 15.18(STD ± 5.77) and control group 4.68(STD ± 2.98). ROC analysis showed an area under the curve of 0.9. A score of 8.5 correlated with presence of neurogenic bowel with sensitivity of 94% and specificity of 87%. CONCLUSION: The questionnaire shows positive reliability and validity when used for pediatric neurogenic bowel patients. The questionnaire differentiates between normal and neurogenic patients. Larger studies are necessary to conduct further validation.

Predicting the Risk of Breakthrough Urinary Tract Infections: Primary Vesicoureteral Reflux.

PURPOSE: We constructed a risk prediction instrument stratifying patients with primary vesicoureteral reflux into groups according to their 2-year probability of breakthrough urinary tract infection. MATERIALS AND METHODS: Demographic and clinical information was retrospectively collected in children diagnosed with primary vesicoureteral reflux and followed for 2 years. Bivariate and binary logistic regression analyses were performed to identify factors associated with breakthrough urinary tract infection. The final regression model was used to compute an estimation of the 2-year probability of breakthrough urinary tract infection for each subject. Accuracy of the binary classifier for breakthrough urinary tract infection was evaluated using receiver operator curve analysis. Three distinct risk groups were identified. The model was then validated in a prospective cohort. RESULTS: A total of 252 bivariate analyses showed that high grade (IV or V) vesicoureteral reflux (OR 9.4, 95% CI 3.8-23.5, p <0.001), presentation after urinary tract infection (OR 5.3, 95% CI 1.1-24.7, p = 0.034) and female gender (OR 2.6, 95% CI 0.097-7.11, p <0.054) were important risk factors for breakthrough urinary tract infection. Subgroup analysis revealed bladder and bowel dysfunction was a significant risk factor more pronounced in low grade (I to III) vesicoureteral reflux (OR 2.8, p = 0.018). The estimation model was applied for prospective validation, which demonstrated predicted vs actual 2-year breakthrough urinary tract infection rates of 19% vs 21%. Stratifying the patients into 3 risk groups based on parameters in the risk model showed 2-year risk for breakthrough urinary tract infection was 8.6%, 26.0% and 62.5% in the low, intermediate and high risk groups, respectively. CONCLUSIONS: This proposed risk stratification and probability model allows prediction of 2-year risk of patient breakthrough urinary tract infection to better inform parents of possible outcomes and treatment strategies.

Synthesis of current pediatric urinary microbiome research.

The human urinary bladder hosts a complex microbial community of low biomass referred to as the urobiome. While the composition of the urobiome has been investigated in adults for over a decade now, only a few studies have considered the presence and composition of the urobiome in children. It is critical to explore how the urobiome develops throughout the life span and how it changes in the presence of various health conditions. Therefore, we set to review the available data on pediatric urobiome composition and its development with age and disease. In addition, we focused on identifying and reporting specific gaps in our knowledge of the pediatric urobiome that we hope will be addressed by future studies in this swiftly developing field with fast-improving methods and consensus.

Characterization of pediatric urinary microbiome at species-level resolution indicates variation due to sex, age, and urologic history.

BACKGROUND: Recently, associations between recurrent urinary tract infections (UTI) and the urinary microbiome (urobiome) composition have been identified in adults. However, little is known about the urobiome in children. We aimed to characterize the urobiome of children with species-level resolution and to identify associations based on UTI history. STUDY DESIGN: Fifty-four children (31 females and 21 males) from 3 months to 11 years of age participated in the study. Catheterized urine specimens were obtained from children undergoing a clinically indicated voiding cystourethrogram. To improve the analysis of the pediatric urobiome, we used a novel protocol using filters to collect biomass from the urine coupled with synthetic long-read 16S rRNA gene sequencing to obtain culture-independent species-level resolution data. We tested for differences in microbial composition between sex and history of UTIs using non-parametric tests on individual bacteria and alpha diversity measures. RESULTS: We detected bacteria in 61% of samples from 54 children (mean age 40.7 months, 57% females). Similar to adults, urobiomes were distinct across individuals and varied by sex. The urobiome of females showed higher diversity as measured by the inverse Simpson and Shannon indices but not the Pielou evenness index or number of observed species (p = 0.05, p = 0.04, p = 0.35, and p = 0.11, respectively). Additionally, several species were significantly overrepresented in females compared to males, including those from the genera Anaerococcus, Prevotella, and Schaalia (p = 0.03, 0.04, and 0.02, respectively). Urobiome diversity increased with age, driven mainly by males. Comparison of children with a history of 1, 2, or 3+ UTIs revealed that urobiome diversity significantly decreases in the group that experienced 3+ UTIs as measured by the Simpson, Shannon, and Pielou indices (p = 0.03, p = 0.05, p = 0.01). Several bacteria were also found to be reduced in abundance. DISCUSSION: In this study, we confirm that urobiome can be identified from catheter-collected urine specimens in infants as young as 3 months, providing further evidence that the pediatric bladder is not sterile. In addition to confirming variations in the urobiome related to sex, we identify age-related changes in children under 5 years of age, which conflicts with some prior research. We additionally identify associations with a history of UTIs. CONCLUSIONS: Our study provides additional evidence that the pediatric urobiome exists. The bacteria in the bladder of children appear to be affected by early urologic events and warrants future research.

Characterization of pediatric urinary microbiome at species-level resolution indicates variation due to sex, age, and urologic history.

Background: Recently, associations between recurrent urinary tract infections (UTI) and the urinary microbiome (urobiome) composition have been identified in adults. However, little is known about the urobiome in children. We aimed to characterize the urobiome of children with species-level resolution and to identify associations based on UTI history. Study design: Fifty-four children (31 females and 21 males) from 3 months to 5 years of age participated in the study. Catheterized urine specimens were obtained from children undergoing a clinically indicated voiding cystourethrogram. To improve the analysis of the pediatric urobiome, we used a novel protocol using filters to collect biomass from the urine coupled with synthetic long-read 16S rRNA gene sequencing to obtain culture-independent species-level resolution data. We tested for differences in microbial composition between sex and history of UTIs using non-parametric tests on individual bacteria and alpha diversity measures. Results: We detected bacteria in 61% of samples from 54 children (mean age 40.7 months, 57% females). Similar to adults, urobiomes were distinct across individuals and varied by sex. The urobiome of females showed higher diversity as measured by the inverse Simpson and Shannon indices but not the Pielou evenness index or number of observed species (p = 0.05, p=0.04, p = 0.35, and p = 0.11, respectively). Additionally, several species were significantly overrepresented in females compared to males, including those from the genera Anaerococcus, Prevotella, and Schaalia (p = 0.03, 0.04, and 0.02, respectively). Urobiome diversity increased with age, driven mainly by males. Comparison of children with a history of 1, 2, or 3+ UTIs revealed that urobiome diversity significantly decreases in the group that experienced 3+ UTIs as measured by the Simpson, Shannon, and Pielou indices (p = 0.03, p = 0.05, p = 0.01). Several bacteria were also found to be reduced in abundance. Discussion: In this study, we confirm that urobiome can be identified from catheter-collected urine specimens in infants as young as 3 months, providing further evidence that the pediatric bladder is not sterile. In addition to confirming variations in the urobiome related to sex, we identify age-related changes in children under 5 years of age, which conflicts with some prior research. We additionally identify associations with a history of UTIs. Conclusions: Our study provides additional evidence that the pediatric urobiome exists. The bacteria in the bladder of children appear to be affected by early urologic events and warrants future research.

Comparing binary & ordinal definitions of urinary & stool continence outcomes: Data from the National Spina Bifida Patient Registry.

INTRODUCTION: The National Spina Bifida Patient Registry (NSBPR) assesses bladder and bowel incontinence using ordinal categories, but prior NSBPR analyses employed binary classification. Our aims were to 1) perform the first NSBPR analysis of bladder and bowel incontinence as ordinal outcomes to compare to the binary definition and subject variables; 2) explore the correlation of incontinence with undergarment usage, and 3) assess incontinence status following continence surgeries. METHODS: Data from NSBPR participants' most recent clinic visit from 2013 to 2020 were analyzed. Ordinal categories of incontinence were compared to previously used binary definitions. Incontinence surgical outcomes were analyzed for those with data at least three months post-operatively. Chi-square tests evaluated associations among categorical variables. Univariate and ordinal logistic regression models were used to test associations of ordinal incontinence status with patient and condition factors. Statistical tests were 2-sided; p values < 0.05 were considered significant. RESULTS: Analysis of 7217 individuals using ordinal incontinence outcomes showed little difference from previously used binary outcomes. The final multivariable logistic regression models with ordinal multinomial outcomes showed that associations of incontinence with age, sex, race/ethnicity, health insurance, level of lesion, and continence management technique were similar to prior studies. Among those reporting never being incontinent of both bladder and bowel, 14% reported using protective undergarments. Of the 500 individuals who had bladder outlet surgery, 38% reported never being incontinent of urine. Of 1416 individuals who had appendicostomy (ACE) bowel surgery, 48% reported never being incontinent of stool. DISCUSSION: Our current analysis showed that ordinal continence outcome classification had similar continence findings as previous studies using the binary definition of continence. Expanding the binary definition of continence to include monthly episodes of incontinence did not greatly increase the proportion of continent individuals and, therefore, would have not likely made meaningful differences in continence outcomes in prior NSBPR analyses. However, it is known that even mild incontinence can affect quality of life, therefore, capturing any level of incontiennce is of clinical importance. Confirmation of the association of continence outcomes with sociodemographic, condition-related, and interventional factors with both approaches further validates previous analyses using the binary definition of continence. CONCLUSION: The previously used binary definition of bladder and bowel continence appears robust. Undergarment choice was a poor surrogate for reported incontinence. After bladder and bowel continence surgeries, 38% and 48%, respectively, reported never being incontinent.

Establishing the first community-centered Spina Bifida research agenda.

INTRODUCTION: Spina bifida (SB) is the most common permanently disabling congenital defect. In 2016, the Spina Bifida Association (SBA) began updating the Guidelines for the Care of People with Spina Bifida (Guidelines). These Guidelines identified over 250 research gaps for the care of individuals with SB. The community of people living with SB prioritized these research gaps to create a formal research agenda that the SBA could support. OBJECTIVE: To present the process and the final research agenda created by individuals with SB, their care partners, clinicians, and researchers. DESIGN: A quantitative survey was developed to allow adults with SB and caregivers of those with SB to rank the impact of each of the 27 topical areas of the Guidelines. The survey was sent via SBA's database to English and Spanish-literate individuals. 1607 responses were captured and analyzed. Two focus groups were convened after survey analysis: adults with SB and caregivers of children with SB. Discussion outlines for the focus groups were developed based on the results from the survey and were used for known-group validation of the highest-ranked topics. The SBA then solicited caregivers of those with SB, adults with SB, and clinical communities to join its initial Research Advisory Council (RAC). Each group generated a list of top research questions to address the gaps in these highest-ranked impact areas. The SBA led discussion groups for each topic area to rank the proposed questions in order of importance to the SB community. They provided content validity and revisions to the language to improve interpretation by the SB community. The final SB Research Agenda was created from the final four to six ranked questions in each of the six topics. RESULTS: A ranking of findings from the quantitative survey identified the two most common topics impacting adults with SB and caregivers of both children and adults with SB were bowel incontinence and urinary incontinence. CONCLUSION: A Research Agenda for SB was rigorously created to prioritize topic areas of highest impact as ranked by individuals in the SB community to fill the research gaps identified in the Guidelines. Bowel and urinary incontinence, both often treated by urologists, were ranked at the top. This agenda will be used to prioritize research efforts to improve the health of those with SB.

COVID-19 vaccination in individuals with spina bifida: A national survey.

PURPOSE: This study aimed to conduct a national survey of individuals with spina bifida (SB) and their care partners to assess COVID-19 vaccination behaviors and vaccine uptake. METHODS: A survey instrument was designed to assess current vaccination status, general perceptions towards vaccinations, and barriers to vaccination within the SB community. Surveys were administered to individuals with SB or their representing care partner. Chi-squared and independent-samples t-tests were used to analyze the relationship between vaccine uptake and demographics. Multivariable logistic regression modeling was used to test which predictors impacted the odds that a participant received a COVID vaccine. RESULTS: A total of 1,412 participants completed the questionnaire, and 1,145 participants reported their COVID-19 vaccine status. The most common reason for not getting vaccinated was a concern about vaccine safety and efficacy. Overall, healthcare professional recommendations played a significant (OR 2.77 p < 0.001) role in whether to get vaccinated. CONCLUSION: About one in five individuals with SB have not received any COVID-19 vaccine. Actionable and modifiable factors were identified which may help increase vaccine uptake. Importantly, health providers play a critical role in COVID-19 vaccination messaging and should emphasize vaccine safety and efficacy.

Who is managing the bowels? A survey of clinical practice patterns in spina bifida clinics.

PURPOSE: Neurogenic bowel dysfunction (NBD) affects 80% of individuals with spina bifida. Performing and disseminating research on NBD to reach the appropriate audience is difficult given the variability among medical specialties managing NBD. This study aimed to identify which medical specialties and types of providers are currently managing NBD in the United States. METHODS: A survey was developed and sent to 75 spina bifida clinics. Surveys queried which specialty was primarily responsible for medical and surgical management of NBD and any others that assist in NBD care. The license and certification level of the providers were collected. Descriptive statistics were performed to describe the results. RESULTS: Response rate was 68%. Urology was the leading specialty primarily responsible for NBD management (39%) followed by rehabilitation medicine and developmental pediatrics (22% and 20%, respectively). Physicians were the primary providers of care followed by nurse practitioners (54% vs 31%). Urology performs 65% of NBD surgeries. CONCLUSION: Multiple specialties and providers are involved in NBD management with variation among clinics. Development of improved NBD care should include a spectrum of specialties and providers. Dissemination of research should be aimed at multiple specialty groups.

Utility estimation for neurogenic bowel dysfunction in the general population.

BACKGROUND: Neurogenic bowel dysfunction (NBD) affects over 80% of individuals with spina bifida causing bowel incontinence and/or constipation. NBD is also associated with decreased quality of life, depression, anxiety, and decreased employment/educational attainment. Because NBD is a life-altering condition without a cure, understanding the utility of different health states related to NBD would aid clinicians as they try to counsel families regarding management options and to better understand the quality of life associated with disease management. OBJECTIVE: To elicit utility scores for NBD using an online community sample. STUDY DESIGN: A cross-sectional anonymous survey was completed by 1534 voluntary participants via an online platform (Amazon Mechanical Turk (MTurk, http://www.mturk.com/)), representing an 87% response rate. The survey presented hypothetical scenarios that asked respondents to imagine themselves as an individual living with NBD or as the caretaker of a child with NBD. The time trade-off (TTO) method was used to estimate a utility score, and outcomes for each scenario were calculated using median and IQR. Univariate comparisons of distributions of TTO for demographic data were made using Kruskal-Wallis tests. RESULTS: The median utility score for NBD was 0.84 [0.70-0.92]. Participants reported that they would give up a median of 5 years of their own life, to prevent NBD in themselves of their child. Utility values for child scenarios were significantly different when stratified by age, gender, race, parental status, marital status, and income. Stratification by current health status did not yield significantly different utility values. DISCUSSION: Study findings are comparable with other TTO-determined utility values of moderately severe disease states, including severe persistent asthma (0.83), moderate seizure disorder (0.84) and mild mental retardation (0.84). The significant variations in utility values based on age, gender, race, parent status, partner/marital status and income variables existed in our study, which is similar to findings in other health fields. Study limitations include lack of unanimous agreement about TTO's validity in measuring utility values, and MTurk participant reports can be generalized to greater population. CONCLUSION: NBD is perceived by the community as having a substantial impact on the lives of children with spina bifida, representing a 16% reduction from perfect health. In general, health state utilities have been increasingly used in healthcare systems to understand how burdensome a population perceives a disease is and to evaluate whether interventions improve quality of life years.

Neurogenic bowel treatments and continence outcomes in children and adults with myelomeningocele.

PURPOSE: Neurogenic bowel dysfunction (NBD) is a common comorbidity of myelomeningocele (MMC), the most common and severe form of spina bifida. The National Spina Bifida Patient Registry (NSBPR) is a research collaboration between the CDC and Spina Bifida Clinics. Fecal continence (continence) outcomes for common treatment modalities for NBD have not been described in a large sample of individuals with MMC. NSBPR patients with MMC and NBD were studied to determine variation in continence status and their ability to perform their treatment independently according to treatment modality and individual characteristics. METHODS: Continence was defined as < 1 episode of incontinence per month. Eleven common treatments were evaluated. Inclusion criteria were established diagnoses of both MMC and NBD, as well as age ⩾ 5 years (n= 3670). Chi-square or exact statistical tests were used for bivariate analyses. Logistic regression models were used to estimate the odds of continence outcomes by age, sex, race/ethnicity, level of motor function, and insurance status. RESULTS: At total of 3670 members of the NSBPR met inclusion criteria between November 2013 and December 2017. Overall prevalence of continence was 45%. Prevalence ranged from 40-69% across different treatments. Among continent individuals, 60% achieved continence without surgery. Antegrade enemas were the most commonly used treatment and had the highest associated continence rate. Ability to carry out a treatment independently increased with age. Multivariable logistic regression showed significantly higher odds of continence among individuals aged ⩾ 12 years, female, non-Hispanic white, and with private insurance.

Lower Urinary Tract Symptoms in Older Children With and Without Diabetes Mellitus.

Lower urinary tract symptoms (LUTS) are an underrecognized complication of diabetes mellitus (DM) in adults and have undergone limited investigation in children. We estimated the prevalence of LUTS in 120 older children (11-17 years) with and without DM and identified patient factors associated with LUTS in logistic regression. Older children (11-17 years) completed a validated LUTS measure and questions about age, ethnicity, gender, body mass index, and degree of bother secondary to LUTS. The unadjusted prevalence of LUTS was 20.87% in the overall cohort, and LUTS was twice as prevalent in children with DM (33.3% vs 16.7%) than children without DM. In logistic regression, Hispanic/Latino ethnicity was positively associated with LUTS (odds ratio = 8.45, P = .011). LUTS may be a prevalent but underrecognized condition, which is more prevalent in Hispanic/Latino and diabetic children.

Evaluation of spina bifida transitional care practices in the United States.

PURPOSE: Recent studies have revealed that the lack of continuity in preparing patients with spina bifida to transition into adult-centered care may have detrimental health consequences. We sought to describe current practices of transitional care services offered at spina bifida clinics in the US. METHODS: Survey design followed the validated transitional care survey by the National Cystic Fibrosis center. Survey was amended for spina bifida. Face validity was completed. Survey was distributed to registered clinics via the Spina Bifida Association. Results were analyzed via descriptive means. RESULTS: Total of 34 clinics responded. Over 90 characteristics were analyzed per clinic. The concept of transition is discussed with most patients. Most clinics discuss mobility, bowel and bladder management, weight, and education plans consistently. Most do not routinely evaluate their process or discuss insurance coverage changes with patients. Only 30% communicate with the adult providers. Sexuality, pregnancy and reproductive issues are not readily discussed in most clinics. Overall clinics self-rate themselves as a 5/10 in their ability to provide services for their patients during transition. CONCLUSIONS: Characteristics of current transitional care services and formal transitional care programs at US clinics show wide variances in what is offered to patients and families.

Endoscopic correction of vesicoureteral reflux simulator curriculum as an effective teaching tool: Pilot study.

INTRODUCTION: It has been well recognized that simulators are effective tools to teach and evaluate technical skills in laparoscopic surgery. Endoscopic injection for the correction of vesicourteral reflux has a definite learning curve. Surgeon experience has also been demonstrated to have an important role in the outcome of the procedure. Simulated training allows for practice in a realistic setting without the inherent risk of harm to the patient. This stress free environment allows the trainee to focus on the acquisition of surgical skills without worry about surgical outcome. OBJECTIVE: The aim was to validate a porcine bladder simulator curriculum for training and assessment of the surgical skills for the endoscopic correction of vesicoureteral reflux. STUDY DESIGN: We developed a porcine bladder-based dextranomer/hyaluronic acid (Dx/HA) injection simulator consisting of a dissected ex vivo porcine bladder in a polystyrene box with the distal ureters and urethra secured (Figure). We performed content validation by five experienced pediatric urologists. We then organized a simulator curriculum, which included lecture, demonstration, and a 2-h hands-on training on the simulator. Content, discriminant, and concurrent validation of the simulator curriculum were carried out using 11 urology trainees at different levels of expertise. All the trainees were evaluated for each step of the procedure of both their first and last performances on the simulator. RESULTS: Overall, the model demonstrated good content validity by all experts (mean questionnaire score 92%). The simulator curriculum demonstrated a significant improvement in the performance of the trainees between their first and last evaluations (56-92%; p = 0.008). Specific parts of the procedure that showed significant improvement (p < 0.05) were identification of the ureteral orifice, ureteral orifice hydrodistention, first and second injection, and location, size, and depth of the mound after injection. DISCUSSION: The Dx/HA endoscopic injection simulator is an effective training tool to improve the performance of the surgeon carrying out the procedure. This teaching tool may be used to help improve the performance of the surgeon carrying out the procedure. This teaching curriculum may shorten the early learning curve historically associated with the procedure and provide a greater understanding of the technical components of successful endoscopic vesicoureteral reflux correction. Additionally, the implementation of this simulator within the developed curriculum can improve the performance of training urologists in all steps of the challenging technique of Dx/HA needle injection confirming concurrent validity. The next step in evaluation of this surgical skill-training curriculum would be to determine if the improvement in skill performance observed during training translates to improved performance in the clinical realm, or predictive validity. LIMITATIONS: Some small differences exist between the porcine model and human ureteral orifices. In the porcine model the ureteral orifices are located medially and distally in the bladder neck, which make injection more challenging. Participants suggested that after practicing with the simulator endoscopic injection to a human ureteral orifice would be easier. CONCLUSION: The simulator curriculum was able to improve the performance of the surgeon carrying out the procedure during subsequent simulations.

Kelly procedure for exstrophy or epispadias patients: Anatomical description of the pudendal neurovasculature.

INTRODUCTION: Adequate penile length in males with bladder exstrophy or epispadias is a major challenge. Kelly previously described a surgical technique of a single stage reconstruction for patients with exstrophy or epispadias that potentially achieves significant penile lengthening by completely detaching the insertion of the corpora cavernosa from the ischiopubic rami. However, because of the possibility of damage to the pudendal neurovascular supply that may lead to partial or complete penile loss, this technique has not gained popularity. The aim of this study is to describe the surgical anatomic relationship of the pudendal neurovascular bundle (NVB) to the ischiopubic rami and to determine a safer approach to dissection during the Kelly procedure. METHODS: We performed meticulous dissection in three formalin-fixed and one fresh adult male cadavers to demonstrate the anatomical relationships between the pudendal neurovascular supply of the penis and the cavernosal insertion to the ischiopubic ramus. RESULTS AND DISCUSSION: We demonstrated the relationships and distance between the NVB and the area of separation between the crus and the ischiopubic ramus at the level of the periosteum. The insertion of the crus to the ischiopubic ramus is inferior lateral, whereas the NVB lies at a superior medial position. This anatomical relationship is best visualized when the dissection is carried out starting from the distal portion of the NVB and proceeding proximally. This area of the periosteum is avascular and the NVB can be preserved safely as long as the dissection is conducted at that subperiosteal level. Based on this cadaver dissection study, we suppose that detaching the corporal cavernosa from the pubic bones at the subperiosteal level allows for a safe distance to be maintained from the pudendal nerve at all times. We believe that if a surgeon performs the dissection inferiorly and laterally, the corpora cavernosa can be safely detached from the ischiopubic ramus and injury to the pudendal vessels and nerve can be avoided. However, it must be noted that there are limitations to applying the results from this study of normal, adult cadavers to the anatomy of children and adolescents with exstrophy or epispadias, who form the largest proportion of patients who are candidates for this procedure. CONCLUSION: This anatomical study demonstrates the relationship between the pudendal NVB, the crus, and the ischiopubic ramus. We demonstrated how the separation of the crus from the ischiopubic periosteum might be performed more safely.