Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial.

OBJECTIVE: The long-term efficacy and safety of polyethylene glycol (PEG) in constipated children are unknown, and a head-to-head comparison of the different PEG formulations is lacking. We aimed to investigate noninferiority of PEG3350 with electrolytes (PEG3350 + E) compared to PEG4000 without electrolytes (PEG4000). METHODS: In this double-blind trial, children aged 0.5 to 16 years with constipation, defined as a defecation frequency of <3 times per week, were randomized to receive either PEG3350 + E or PEG4000. Primary outcomes were change in total sum score (TSS) at week 52 compared to baseline, and dose range determination. TSS was the sum of the severity of 5 constipation symptoms rated on a 4-point scale (0-3). Noninferiority margin was a difference in TSS of ≤1.5 based on a 95%-confidence interval [CI]. Treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence. RESULTS: Ninety-seven subjects were included, of whom 82 completed the study. Mean reduction in TSS was -3.81 (95% CI: -4.96 to -2.65) and -3.74 (95%CI: -5.08 to -2.40), for PEG3350 + E and PEG4000, respectively. Noninferiority criteria were not met (maximum difference between groups: -1.81 to 1.68). Daily sachet use was: 0 to 2 years: 0.4 to 2.3 and 0.9 to 2.1; 2 to 4 years: 0.1 to 3.5 and 1.2 to 3.2; 4 to 8 years: 1.1 to 2.8 and 0.7 to 3.8; 8 to 16 years 0.6 to 3.7 and 1.0 to 3.7, in PEG3350 + E and PEG4000, respectively. Treatment success after 52 weeks was achieved in 50% and 45% of children, respectively (P = 0.69). Rates of adverse events were similar between groups, and no drug-related serious adverse events occurred. CONCLUSIONS: Noninferiority regarding long-term constipation-related symptoms of PEG3350 + E compared to PEG4000 was not demonstrated. However, analysis of secondary outcomes suggests similar efficacy and safety of these agents.

Home screening for bacteriuria in children with spina bifida and clean intermittent catheterization.

BACKGROUND: Significant bacteriuria (SBU) and urinary tract infections (UTIs) are common in patients with spina bifida and neuropathic detrusor sphincter dysfunction. Laboratory agar plated culture is the gold standard to establish SBU. It has the disadvantage of diagnostic and subsequent therapeutic delay. Leukocyte esterase tests (LETs) and dip slides proved to be useful in the general populations to exclude SBU and UTI. The aim of this study was to evaluate the reliability of LET and dip slide in children with spina bifida without symptoms of UTI. The reliability in children with asymptomatic SBU was not studied before. METHODS: In one hundred and twelve children with spina bifida on clean intermittent catheterization LETs and dip slides were compared with laboratory cultures. Both tests and agar plated cultures were performed on catheterized urine samples. The hypothesis was that the home tests are as accurate as laboratory cultures. RESULTS: A SBU was found in 45 (40%) of the 112 laboratory cultures. A negative LET excluded SBU (negative predictive value 96%), while a positive LET had a positive predictive value of 72%. The false positive rate was 28%. Dip slide determination of bacterial growth had no added value, other than serving as transport medium. CONCLUSIONS: In spina bifida children, leukocyte esterase testing can be used to exclude significant bacteriuria at home, while dip slide tests have no added value to diagnose or exclude significant bacteriuria.

Antibiotic prophylaxis for urinary tract infections in children with spina bifida on intermittent catheterization.

PURPOSE: Antibiotic prophylaxis (low dose chemoprophylaxis) has been prescribed since the introduction of clean intermittent catheterization in children with spina bifida. We hypothesized that stopping low dose chemoprophylaxis does not increase the number of urinary tract infections in these patients. MATERIALS AND METHODS: A total of 176 patients with spina bifida participated in a randomized controlled trial (ISRCTN trial number 56278131) of either continuation or discontinuation of low dose chemoprophylaxis. During the 18-month study period biweekly urine samples were evaluated for leukocyturia and bacteriuria with dipsticks and cultures. Asymptomatic significant bacteriuria (positive culture results without clinical symptoms) and urinary tract infections (significant bacteriuria with clinical symptoms and leukocyturia) were analyzed. RESULTS: Discontinuation of low dose chemoprophylaxis resulted in higher rates of asymptomatic significant bacteriuria (incidence rate ratio 1.23, 95% CI 1.08-1.40, p = 0.002) and urinary tract infection (IRR 1.44, 95% CI 1.13-1.83, p = 0.003). For urinary tract infection the number needed to harm was 2.2, that is if 2 patients discontinued low dose chemoprophylaxis for a year, 1 extra urinary tract infection would result. Febrile urinary tract infection occurred once in every 30 patient-years and slightly more often in the discontinuation group (relative risk 2.0, 95% CI 0.38-10.6, p = 0.4). Of 88 patients allocated to discontinuation of low dose chemoprophylaxis 38 (43%) switched back to chemoprophylaxis. The urinary tract infection rate was nonsignificantly higher in the presence of vesicoureteral reflux. Male gender and a low pre-study rate of urinary tract infection predicted successful discontinuation. CONCLUSIONS: Patients with spina bifida on clean intermittent catheterization and antibiotic prophylaxis for urinary tract infections can safely discontinue this prophylaxis, in particular males, patients with low urinary tract infection rates and patients without vesicoureteral reflux.

Case Report: Uterine Anomalies in Girls With a Congenital Solitary Functioning Kidney.

Unilateral renal agenesis and multicystic dysplastic kidney, resulting in a contralateral solitary functioning kidney (SFK), are part of the broad spectrum of congenital anomalies of the kidney and urinary tract (CAKUT). In girls with SFK, screening for asymptomatic Müllerian anomalies of uterus and vagina is not yet routinely performed, and therefore often overlooked until clinical complications in the menstrual cycle or fertility process occur. In this case series, we report on four teenagers with congenital SFK presenting with menstrual problems due to a Müllerian anomaly. Routine peri-menarchal screening for Müllerian anomalies in girls with SFK may provide timely counseling, surgical treatment and prevention of associated complications such as endometriosis, infertility and miscarriages.

Bariatric Surgery in Youth: the Perspective of Dutch Pediatricians, Parents, and Adolescents.

BACKGROUND: Recent studies have indicated that bariatric surgery is effective for the treatment of youth with severe obesity. The attitudes of pediatricians, parents, and adolescents regarding this topic remain unclear. Therefore, the aim of this study was to assess the current thoughts and beliefs of Dutch pediatricians, parents, and adolescents regarding bariatric surgery in youth. METHODS: An online survey containing twenty questions on bariatric surgery in youth was distributed to pediatricians of the Dutch Society of Pediatrics. Parents and adolescents who participated in an interdisciplinary care program for overweight, obesity, and severe obesity filled out an online survey of twelve questions. RESULTS: One hundred and twenty-one pediatricians, 49 parents, and 19 adolescents completed the surveys. Seventy-two pediatricians (59.5%) considered bariatric surgery to be an effective treatment for youth with severe obesity when conventional treatment fails, and intend to refer patients for bariatric surgery. The most frequently suggested conditions for bariatric surgery were a minimum age of 16 years (n = 59, 48.7%), a BMI threshold of 40 kg/m2 (n = 51, 42.2%), and a minimum Tanner stage of IV (n = 59, 48.8%). Thirty parents (61.2%) and fourteen adolescents (73.7%) responded that bariatric surgery should become available for youth with severe obesity. CONCLUSION: Dutch pediatricians, parents, and adolescents increasingly accept bariatric surgery as a treatment modality in youth with severe obesity who do not respond successfully to lifestyle intervention. Whether pediatricians will actually refer youth for bariatric surgery remains to be seen when this treatment option will be implemented in the Netherlands.

Urinary tract infections in children with spina bifida: an inventory of 41 European centers.

The introduction of clean intermittent catheterization (CIC) in 1972 and low-dose chemoprophylaxis (LDCP, antibiotic prophylaxis), anticholinergic medication and urological surgery in the mid-1980s has improved the long-term outcome of renal function in children with neurogenic bladder sphincter dysfunction (NBSD) due to spina bifida (SB). We have conducted a European survey of the protocols for diagnosing and treating urinary tract infections (UTIs) in these children, using a web-based questionnaire. The responses from 41 centers in 14 European countries confirm that although most centers have standardized protocols for treating UTIs, there is no consensus among European centers in terms of protocols for preventing, diagnosing and treating UTIs in children with NBSD and for CIC.