Mandy Rickard

Cause and Effect versus Confounding—Is There a True Association between Caudal Blocks and Tubularized Incised Plate Repair Complications?

Purpose: We studied the impact of caudal block vs dorsal penile block on the rate of urethrocutaneous fistula and glans dehiscence in children who underwent hypospadias repair. Materials and Methods: We retrospectively reviewed the records of 849 consecutive patients who underwent tubularized incised plate repair between 2004 and 2015. A total of 331 cases with incomplete medical records, other techniques and redo repair were excluded. The preference for caudal block was based on anesthesiologist discretion. Age at surgery, meatal location, preoperative testosterone stimulation, type of regional anesthesia (caudal block vs dorsal penile block), degree of ventral curvature, surgeon expertise and complications (urethrocutaneous fistula/glans dehiscence) were captured. Univariate and multivariable analyses were done of risk factors for complications. Results: Median age at surgery was 18 months and median followup was 6 months. Of 518 patients 405 (78%) had distal and 113 (22%) had mid shaft/proximal defects. Complications developed in 37 cases (7%), including urethrocutaneous fistula in 21 (19 with a caudal block and 2 with a dorsal penile block) and glans dehiscence in 16 (13 with a caudal block and 3 with a dorsal penile block). On univariate analysis preoperative testosterone stimulation vs no preoperative testosterone stimulation (13.0% vs 6.2% of cases, p = 0.04), mid shaft/proximal vs distal defects (15.9% vs 4.7%, p <0.01) and caudal block (8.7% vs 3.3%, p = 0.03) were significantly associated with more complications. However, on multivariable analysis the associations of preoperative testosterone stimulation (OR 1.2, 95% CI 0.4–3.7) and caudal block (OR 2.4, 95% CI 0.9–6.4) with complications did not hold. Only the combination of meatal location/ventral curvature remained as an independent risk factor for urethrocutaneous fistula/glans dehiscence (OR 2.4, 95% CI 1.1–5.7, p = 0.04). Conclusions: Our data indicate that hypospadias severity and not the type of regional anesthesia was the only risk factor significantly associated with postoperative complications. To confirm these findings and provide strong and definitive evidence on this topic a well powered, randomized, controlled trial is clearly required.

Bladder Training Video versus Standard Urotherapy for Bladder and Bowel Dysfunction: A Noninferiority Randomized, Controlled Trial

Purpose: We evaluated whether an animated bladder training video was as effective as standard individual urotherapy in improving bladder/bowel symptoms. Materials and Methods: Patients 5 to 10 years old who scored greater than 11 on the bladder/bowel Vancouver questionnaire were included in a noninferiority randomized, controlled trial. Children with vesicoureteral reflux, neuropathic bladder, learning disabilities, recent urotherapy or primary nocturnal enuresis were excluded from analysis. Patients were randomly assigned to receive standard urotherapy or watch a bladder training video in clinic using centralized blocked randomization schemes. Bladder/bowel symptoms were evaluated at baseline and 3‐month followup by intent to treat analysis. A sample size of 150 patients ensured a 3.5 difference in mean symptomology scores between the groups, which was accepted as the noninferiority margin. Results: Of 539 screened patients 173 (37%) were eligible for study and 150 enrolled. A total of 143 patients (95%) completed the trial, 5 (4%) were lost to followup and 2 (1%) withdrew. Baseline characteristics were similar between the groups. Baseline mean ± SD symptomology scores were 19.9 ± 5.5 for the bladder training video and 19.7 ± 6.0 for standard urotherapy. At 3 months the mean symptomology scores for the bladder training video and standard urotherapy were reduced to 14.4 ± 6.5 and 13.8 ± 6.0, respectively (p = 0.54). The mean difference was 0.6 (95% CI –1.4–2.6). The upper 95% CI limit of 2.6 did not exceed the preset 3.5 noninferiority margin. Conclusions: The bladder training video was not inferior to standard urotherapy in reducing bladder/bowel symptoms in children 5 to 10 years old. The video allows families to have free access to independently review bladder training concepts as often as necessary.

MP61-08 VOIDING CYSTOURETHROGRAM AND ANTIBIOTIC PROPHYLAXIS FOR PRENATAL HYDRONEPHROSIS: SURPRISING RESULTS FROM A SURVEY OF SFU MEMBERS’ PRACTICE PATTERNS

Source of Funding: Data is this study were collected by the Chronic Kidney Disease in children prospective cohort study (CKiD) with clinical coordinating centers (Principal Investigators) at Children’s Mercy Hospital and the University of Missouri Kansas City (Bradley Warady, MD) and Children’s Hospital of Philadelphia (Susan Furth, MD, Ph.D.), Central Biochemistry Laboratory (George Schwartz, MD) at the University of Rochester Medical Center, and data coordinating center (Alvaro MuO1oz, Ph.D). at the Johns Hopkins Bloomberg School of Public Health. The CKiD is funded by the National Institute of Diabetes and Digestive Kidney Diseases, with additional funding from the National Institute of Child Health and Human Development, and the National Heart, Lung, and Blood Institute (U01-DK-66143, U01-DK-66174, U01-DK-082194, U01-DK-66116).

MP61-03 QUALITY OF REPORTING AND FRAGILITY INDEX FOR RANDOMIZED CONTROLLED TRIALS IN THE VESICOURETERAL REFLUX LITERATURE – WHERE DO WE STAND?

INTRODUCTION AND OBJECTIVES: Randomized controlled trials (RCTs) are the “gold standard” methodology for determining whether treatment effects are due to chance. The fragility index (FI) is used to determine the number of events that would be required to change significant positive results to non-significant (p>0.05). Herein, we assess the quality of reporting of RCTs in vesicoureteral reflux (VUR) literature using the 2010 CONSORT statement, and for studies with significant positive findings, calculate the FI as a measure of robustness of the results. METHODS: A comprehensive search was conducted through MEDLINE and Embase to identify RCTs in VUR literature from 2000-16. Two reviewers independently selected articles, and evaluated them using the 2010 CONSORT checklist. An overall quality of reporting score (OQR) was calculated by dividing the number of checklist items present in each study by the maximum possible score (34) and expressed as a percentage. Studies were classified as low (<40%), moderate (40-70%) and high quality (>70%). A methodological index score (MIS) out of 4 was assigned based on: sample size justification, allocation concealment, randomization method, and blinding of outcome assessors. Of 2052 initial results, 2003 (98%) were excluded because they did not focus on VUR/were not RCTs. After full text screening of 50 articles, we excluded 28 (56%) that did not meet our criteria. For studies reporting significant positive results, we calculated the FI by manually adding events to the group with fewest events until the p value was no longer significant. RESULTS: Of the 22 included studies, the mean OQR was 45 16% with 9 (41%) identified as low, 11 (50%) as moderate and 2 (9%) as high quality (Table 1). The mean MIS was 1.95 1. There was no difference in OQR between studies published from 2007-16 (n1⁄415) versus those before 2007 (n1⁄47) (41 15% vs. 44 20%, p1⁄40.70) or RCTs with a sample size >100 (n1⁄415) vs. <100 (n1⁄47) (40 15% vs. 46 17%, p1⁄40.41). However, we noted a difference when we compared RCTs with biostatistician support (n1⁄44) vs. those without (n1⁄418) (62 9% vs. 40 14%, p<0.01). 7 studies reported significant positive results making calculation of FI possible. The mean FI was 5.8 5.1 indicating that most studies were fragile. There was no correlation between the OQS and FI. CONCLUSIONS: The current OQR in VUR literature is suboptimal. In addition, most FI scores were between 1-5 indicating that only a few events would be required to completely change the results of these studies. Implementation of the CONSORT checklist as a prerequisite for submission of manuscripts may improve the quality of reporting, and calculation of the FI could provide readers with an objective measure of robustness for the reported results.

MP55-04 REVISITING THE ROLE OF GENDER ON EARLY DIAGNOSED PRIMARY VESICOURETERAL REFLUX IN INFANTS WITH PRENATAL HYDRONEPHROSIS

characterize the inter-rater reliability of VUR grade and UDR in children with VUR. METHODS: Voiding cystourethrograms (VCUG) of 20 pediatric patients (31 VUR-affected kidneys) were independently reviewed by four pediatric urologists in a blinded fashion. For each renal unit, grade was assigned according to the standardized international scale. UDR was calculated by dividing the largest ureteral diameter within the false pelvis by the distance between the L1-L3 vertebral bodies. The mean grade and mean UDR was calculated for each affected kidney. Correlation within each rater was determined using a Pearson’s correlation coefficient. Reliability of VUR grade and UDR was calculated using intraclass correlation coefficients (ICC) using a two-way ANOVA model interrater agreement. RESULTS: VUR grade (ICC 1⁄4 0.87, 95% CI 1⁄4 0.78-0.93) and UDR (ICC 1⁄4 0.95, 95% CI 1⁄4 0.92-0.97) were reliably measured by four independent raters. While UDR and grade were equally reliable measures, UDR had a tighter confidence interval. For each rater, grade and UDR were well-correlated (r 1⁄4 0.73-0.84; p <0.0001). In the upper ranges of measurements, grade was more variable than UDR [Figure]. Using an empirical threshold, the increased variability with grade may lead to significantly more differences in clinical decision-making among physicians (p 1⁄4 0.022). CONCLUSIONS: UDR has good inter-rater reliability among pediatric urologists. There was significantly more clinically relevant variability with grade than with UDR. Our study demonstrates that UDR is a more objective and reliable measure than grade, and may be a useful adjunct in clinical decision making and categorizing VUR.