Use of ChatGPT in Urology and its Relevance in Clinical Practice: Is it useful?

PURPOUSE: One of the many artificial intelligence based tools that has gained popularity is the Chat-Generative Pre-Trained Transformer (ChatGPT). Due to its popularity, incorrect information provided by ChatGPT will have an impact on patient misinformation. Furthermore, it may cause misconduct as ChatGPT can mislead physicians on the decision-making pathway. Therefore, the aim of this study is to evaluate the accuracy and reproducibility of ChatGPT answers regarding urological diagnoses. MATERIALS AND METHODS: ChatGPT 3.5 version was used. The questions asked for the program involved Primary Megaureter (pMU), Enuresis and Vesicoureteral Reflux (VUR). There were three queries for each topic. The queries were inserted twice, and both responses were recorded to examine the reproducibility of ChatGPT's answers. Afterwards, both answers were combined. Finally, those rwere evaluated qualitatively by a board of three specialists. A descriptive analysis was performed. RESULTS AND CONCLUSION: ChatGPT simulated general knowledge on the researched topics. Regarding Enuresis, the provided definition was partially correct, as the generic response allowed for misinterpretation. For VUR, the response was considered appropriate. For pMU it was partially correct, lacking essential aspects of its definition such as the diameter of the dilatation of the ureter. Unnecessary exams were suggested, for Enuresis and pMU. Regarding the treatment of the conditions mentioned, it specified treatments for Enuresis that are ineffective, such as bladder training. Therefore, ChatGPT responses present a combination of accurate information, but also incomplete, ambiguous and, occasionally, misleading details.

Are weight or age limits for pediatric laparoscopic pyeloplasty? Results of a multicentric study.

INTRODUCTION: Anderson-Hynes pyeloplasty is the technique of choice for the treatment of pyeloureteral junction obstruction (PUJO) with an excellent success rate. Minimally invasive surgery has become the standard of care for the management of PUJO in children. Although it has been comparable to the open approach at all levels, its diffusion or employment in younger children has not been widely adopted. Our aim is to evaluate laparoscopic pyeloplasty outcomes from international academic centers in children under 1 year of age, focusing on feasibility and outcomes including possible complications. MATERIALS AND METHODS: This is review of consecutive infants under 1 year of age who underwent laparoscopic pyeloplasty between 2009 and 2018 with more than 12 months of follow-up. Seven different training centers with different backgrounds participated in this study. Evaluation was carried out with ultrasound and renogram before and after surgery. Demographic data, perioperative characteristics, complications, and results are described and analyzed. RESULTS: Over 9 years, 124 transperitoneal laparoscopic Anderson-Hynes pyeloplasties were performed on 123 children under 1 year of age; 88 males and 35 females, with 1 case of bilateral PUJO. Of the 124 renal units, 86 were left-sided. Mean age at surgery was 6.6 months (1 week-12 months), with 56% (n = 70) done before 6 months of age. Mean weight at surgery was 6.8 kg (3-12 kg), with 59% (n = 73) weighing less than 8 kg. Mean operative time (skin-to-skin) was 150 min (75-330 min). After a mean follow-up of 46 months (12-84 months), 12 (9%) patients developed complications, with only 1 needing a redo pyeloplasty also done laparoscopically. One child, with deterioration in renal function, underwent nephrectomy. CONCLUSION: Laparoscopic pyeloplasty under 1 year of age and/or less than 12 kilos is feasible with lower complication rate. Furthermore, age younger than 6 months and weight less than 8 kg are no longer limiting factors for a successful pyeloplasty as shown by this multicentre study.

Randomized Controlled Trial of Scrotal versus Inguinal Orchidopexy on Postoperative Pain.

INTRODUCTION: To compare the impact of orchidopexy approach (scrotal vs inguinal) on analgesic requirements, postoperative pain scores and complication rates. MATERIALS AND METHODS: A superiority randomized controlled trial including boys 10 to 95 months of age at surgery, diagnosed with palpable undescended testis, was conducted. Patients with nonpalpable or bilateral undescended testis, previous inguinal surgery on the ipsilateral side and concurrent procedures were excluded. Block randomization with 1:1 allocation ratio and a standardized anesthesia protocol were employed. The primary outcome was postoperative pain and analgesic use in-hospital and at home using the validated pain scales FLACC (Face, Legs, Activity, Cry, and Consolability Behavioural Scale), CHEOPS (Children's Hospital of Eastern Ontario Pain Scale), PPPM (Parents Postoperative Pain Measure) and TPPPS (Toddler-Preschooler Postoperative Pain Scale). Secondary outcomes included operative time, conversion and success rates, and complications. An intention to treat protocol was followed. RESULTS: We enrolled 173 patients, and 12 withdrew. Of the 161 patients who completed followup, 80 had scrotal orchidopexy and 81 inguinal orchidopexy. In-hospital use of ibuprofen (p=0.02) and acetaminophen (p <0.01), as well as FLACC (p <0.01) and CHEOPS (p=0.04) pain scores were slightly higher in patients who underwent orchidopexy. No difference in mean operative time and median at-home administration of analgesic was noted. The conversion rate was 24% (19/80). Of these, 13 (68%) were canalicular testes. The overall complication rate was 4% (6/161): 1 testicular atrophy, 3 re-ascents and 2 wound infections. Of these, 5 underwent scrotal orchidopexy and 1 had inguinal orchidopexy (wound infection). CONCLUSIONS: Even though in-hospital mean postoperative pain scores and analgesic consumption were slightly lower for scrotal orchidopexy cases, the pain levels were mild across all scales. Median at-home analgesic use and pain scores were similar for both groups, as well as operative time and complication rates. Scrotal orchidopexy is an effective alternative to inguinal orchidopexy for low-lying undescended testis, as 68% of cases that needed conversion were canalicular testes.

What Do Patients and Parents Say About Parents' Ability to Choose Early Genital Surgery for Girls with Congenital Adrenal Hyperplasia?

PURPOSE: We assessed opinions of females with congenital adrenal hyperplasia and their parents about the parent's ability to choose early genital surgery for these patients. MATERIALS AND METHODS: We conducted an online survey of females with congenital adrenal hyperplasia (46XX,16+ years old) and independently recruited parents (2019-2020) diagnosed in first year of life in the United States. A multidisciplinary medical team, women with congenital adrenal hyperplasia and parents drafted the survey. Fisher exact test was used. RESULTS: Of 57 females with congenital adrenal hyperplasia (median age 39 years), 93.0% underwent genital surgery (median 1-2 years old). Most females (79.0%) believed legislation prohibiting surgery in childhood would cause harm. Most (64.9%) believed a ban "would have been harmful to me" (24.6% not harmful, 10.5% neutral). Most females (70.2%) believed a ban undermined parental rights to make medical decisions in their child's best interest. While 75.4% did not believe a ban was in the best interest of females with congenital adrenal hyperplasia, 14.0% did (10.5% neutral). For 132 parents of females with congenital adrenal hyperplasia (parent/child median age 40/11 years), 78.8% of children underwent surgery (median <1 year old). Most parents (93.9%) believed legislation prohibiting surgery in childhood would cause harm. Most (77.3%) believed a ban "would have harmed my daughter" (12.1% no harm, 5.3% neutral, 5.3% no answer). Parents were more likely than females with congenital adrenal hyperplasia to oppose a ban (p ≤0.02). Most parents (90.9%) believed a ban undermined parental rights. While 93.9% did not believe a ban was in the best interest of females with congenital adrenal hyperplasia, 3.8% did (2.3% neutral). CONCLUSIONS: The majority of females with congenital adrenal hyperplasia and their parents support the parents' ability to decide about potential genital surgery, opposing moratoria on surgery in childhood.

How I do it open distal ureteroureterostomy for ectopic ureters in infants with duplex systems and no vesicoureteral reflux under 6 months of age.

We describe a step by step technique for open distal ureteroureterostomy (UU) in infants less than 6 months presenting with duplex collecting system and upper pole ectopic ureter in the absence of vesicoureteral reflux (VUR).

Pulse front tilt control using non-collimated beams in a single pass grating compressor.

High power laser systems based on the chirped pulse amplification (CPA) technique make use of grating pairs to compress the pulse to a short duration. When designing the pulse compressor, it is normally assumed that good beam collimation is a strong requirement in order to avoid spatio-temporal couplings. We analyze the propagation through a single pass compressor without the good collimation approximation and show that this results in a compressed pulse exhibiting pulse front tilt, whose magnitude is proportional to the normalized distance to the beam waist, providing a simple mechanism for controlling the tilt angle. We perform experimental measurements in a large-scale CPA laser for a range of beam curvatures that confirm these results.

Antibiotic prophylaxis for prevention of urinary tract infections in the first year of life in children with vesicoureteral reflux diagnosed in the workup of antenatal hydronephrosis: a systematic review.

BACKGROUND: Children with antenatal hydronephrosis (ANH) diagnosed with postnatal asymptomatic vesicoureteral reflux (VUR) are thought to be at higher risk of urinary tract infection (UTI). As such, continuous antibiotic prophylaxis (CAP) is empirically recommended until age of toilet training; however, there are limited data to support this. The objective of this systematic review was to summarize the existing data and compare UTI rates in infants with asymptomatic VUR on CAP during the first year of life, to those not on CAP. Secondary objectives were to determine associated risk factors with UTI development. METHODS: A systematic search of all relevant studies and abstracts was conducted using 4 electronic databases by utilizing appropriate key words by an expert hospital librarian. Eligible studies included children with prenatal hydronephrosis, asymptomatic VUR with or without CAP, and reported on development of UTI in the first year. RESULTS: Of 6903 citations screened, 18 were selected, giving a total population of 829 (69.4% male, median age 57 days) who met the inclusion criteria. Most studies were retrospective and of low-quality evidence. Overall, 15.4% of patients developed at least one breakthrough UTI and females had a higher risk of UTI (odds ratio (OR) 2.3, 95% CI 1.1-4.7). Comparison with children not taking CAP was not readily reported, and meta-analysis could not be completed. CONCLUSIONS: Randomized controlled trials and standardized reporting of clinical variables are required to understand the protective effect of antibiotic prophylaxis in this cohort.

IGF-1 and IGF-1R modulate the effects of IL-4 on retinal ganglion cells survival: The involvement of M1 muscarinic receptor.

Trophic factors are involved in different cellular responses. Previously we demonstrated that IL-4 treatment induces an increase in retinal ganglion cell survival (RGCS) and regulates cholinergic differentiation of retinal cells in vitro. Data from literature show that IGF-1 also promotes RGCS, an effect mediated by PI-3K/AKT pathway. The aim of this study was to investigate the role of IGF-1 and IGF-1R on RGCS mediated by IL-4 treatment and the role of M1 acetylcholine receptors in this effect. Here we show that the effect of IL-4 on RGCS depends on IGF-1 and IGF-1R activation, the PI-3K/AKT and NFkB intracellular pathways and depends on M1 mAChRs activation. IGF-1 increases the levels of M1 mAChRs in 15min, 45min, 24 h and 48 h in mixed retinal cells culture, modulates the levels of IL-4, pIGF-1R, IGF-1R. IL-4 modulates IGF-1, pIGF-1R and IGF-1R levels in different time intervals. These results put in evidence a crosstalk between IL-4 and IGF-1 and a role of M1 mAChRs, IGF-1 and IGF-1R in RGCS mediated by IL-4.

Gubernaculum Testis and Cremasteric Vessel Preservation during Laparoscopic Orchiopexy for Intra-Abdominal Testes: Effect on Testicular Atrophy Rates.

PURPOSE: Gubernaculum sparing laparoscopic orchiopexy, which involves anatomical delivery of the testis through the internal inguinal ring, has been proposed as an alternative to conventional laparoscopic Fowler-Stephens orchiopexy, maximizing collateral blood supply and potentially decreasing atrophy rates. We compared the 2 techniques to test this hypothesis. MATERIALS AND METHODS: The primary (dependent) outcome of the study was rate of testicular atrophy, which was defined as palpation of a nubbin or inability to palpate a testis (complete atrophy) on postoperative physical examination at 3 and 12 months. Doppler ultrasound was obtained routinely to further confirm the diagnosis of testicular atrophy. Independent variables that were captured were age at surgery, type of procedure (conventional laparoscopic Fowler-Stephens orchiopexy vs gubernaculum sparing laparoscopic orchiopexy), surgical approach (single vs 2-stage), location of intra-abdominal testis (high vs low) and patency of the internal inguinal ring. RESULTS: Mean ± SD age at surgery was 25.7 ± 13.3 months (median 22). Laparoscopy was carried out for nonpalpable testes and revealed vanishing intra-abdominal testes in 120 cases (29%), peeping testes in 80 (19%) and intra-abdominal testes in 212 (51%), with 104 being low and 108 being high in the abdomen. A single stage procedure was performed in 44 cases (21%) and a 2-stage procedure in 168 (79%). Based on surgeon preference, conventional laparoscopic Fowler-Stephens orchiopexy was undertaken in 46 patients (22%) and gubernaculum sparing laparoscopic orchiopexy in 166 (78%). Overall testicular atrophy rate was 6.6% (14 of 212 cases). Atrophy was observed in 13 of 46 testes after conventional laparoscopic Fowler-Stephens orchiopexy and 1 of 166 following gubernaculum sparing laparoscopic orchiopexy (28.3% vs 0.6%, p <0.01). CONCLUSIONS: Gubernaculum sparing laparoscopic orchiopexy is a feasible alternative to conventional laparoscopic Fowler-Stephens orchiopexy. Our findings suggest that preservation of additional vascular supply to the testis (cremasteric vessels and deferential artery) may translate into improved testicular survival rates following laparoscopic orchiopexy.

PKC delta activation increases neonatal rat retinal cells survival in vitro: Involvement of neurotrophins and M1 muscarinic receptors.

Protein kinase C (PKC) is a family of serine/threonine kinases related to several phenomena as cell proliferation, differentiation and survival. Our previous data demonstrated that treatment of axotomized neonatal rat retinal cell cultures for 48 h with phorbol 12-myristate 13-acetate (PMA), a PKC activator, increases retinal ganglion cells (RGCs) survival. Moreover, this treatment decreases M1 receptors (M1R) and modulates BDNF levels. The aim of this work was to assess the possible involvement of neurotrophins BDNF and NGF in the modulation of M1R levels induced by PKC activation, and its involvement on RGCs survival. Our results show that PMA (50 ng/mL) treatment, via PKC delta activation, modulates NGF, BDNF and M1R levels. BDNF and NGF mediate the decrease of M1R levels induced by PMA treatment. M1R activation is essential to PMA neuroprotective effect on RGCs as telenzepine (M1R selective antagonist) abolished it. Based on our results we suggest that PKC delta activation modulates neurotrophins levels by a signaling pathway that involves M1R activation and ultimately leading to an increase in RGCs survival in vitro.

Society for Fetal Urology Classification vs Urinary Tract Dilation Grading System for Prognostication in Prenatal Hydronephrosis: A Time to Resolution Analysis.

PURPOSE: The Urinary Tract Dilation grading system for prenatal hydronephrosis was introduced to address potential shortcomings of the Society for Fetal Urology classification. Hydronephrosis resolution is an important patient outcome and is frequently discussed during family counseling. We compared these 2 grading systems and their ability to predict time to hydronephrosis resolution. MATERIALS AND METHODS: We prospectively screened 855 patients with prenatal hydronephrosis due to ureteropelvic junction obstruction-like hydronephrosis, nonrefluxing primary megaureter or vesicoureteral reflux between 2009 and 2015. Of the patients 454 were excluded due to surgery, late referral, absence of postnatal dilatation or presence of other anomalies, resulting in 401 eligible patients (of whom 81% were male) to be included for analyses. Hydronephrosis grades collected at baseline and last followup were compared to identify resolution trends through time. Hydronephrosis resolution was defined as renal pelvis anteroposterior diameter 10 mm or less at last followup. Time to resolution was analyzed using Cox proportion regression. RESULTS: Of 401 patients 328 (82%) had resolution during a mean ± SD followup of 24 ± 18 months (maximum 107). Cumulative resolution rate at 3 years was 98% for Society for Fetal Urology grade I hydronephrosis, 87% for grade II, 76% for grade III and 57% for grade IV. The 3-year hydronephrosis resolution rate was 90% for Urinary Tract Dilation postnatal grade 1 (low risk), 81% for grade 2 (intermediate risk) and 71% for grade 3 (high risk). CONCLUSIONS: Patients with distinctive baseline hydronephrosis grades (classified by Society for Fetal Urology or Urinary Tract Dilation system) had significantly different resolution times for hydronephrosis (p <0.001). Counseling families regarding time to resolution of prenatal hydronephrosis should remain the same whether using Society for Fetal Urology or Urinary Tract Dilation grading system.

Apparent digestibility of conventional and alternative feedstuffs by hybrid tambacu juveniles.

The apparent digestibility coefficients (ADC's) of dry matter (DM), crude protein (CP), and gross energy (GE) of conventional feedstuffs (cottonseed meal-CSM, soybean meal-SBM, wheat bran-WHB, corn-COR) and regional alternative feedstuffs (common bean residue meal-CBR, mesquite meal-MES, pasta by-product meal-PBM) were determined for hybrid juvenile tambacu Colossoma macropomum × Piaractus mesopotamicus. The apparent DM and GE digestibility of feedstuffs decreased (p<0.05) as fiber content of the ingredients increased. No differences (p>0.05) were found among ADC's of PBM and COR. The lowest CP ADC among energy sources was observed in MES; the lowest CP ADC among plant protein sources was observed in CBR. Information about the ADC's of conventional and alternative feedstuffs for tambacu is essential to formulate low-cost diets and can contribute to regional development.

Users' guide to the surgical literature: how to assess a qualitative study.

SUMMARY: Qualitative research contributes to the medical literature through the observation, description and interpretation of theories about social interactions and individual experiences as they occur in their natural setting. This type of research has the potential to enhance the understanding of surgeons' and patients' preferences, attitudes and beliefs, as well as assess how these may change with time. To date, there is no widely accepted standard for the methodological assessment of qualitative research. Despite ongoing debate, this article seeks to familiarize surgeons with the basic techniques for the critical appraisal of qualitative studies in the surgical literature.

Associations of Initial Society for Fetal Urology Grades and Urinary Tract Dilatation Risk Groups with Clinical Outcomes in Patients with Isolated Prenatal Hydronephrosis.

PURPOSE: There are limited comparative data on the predictive value of the 2 most commonly used classification systems, that is SFU (Society for Fetal Urology) hydronephrosis grades and urinary tract dilatation risk groups, in regard to the future risk of surgical intervention and the development of febrile urinary tract infection. We explored this topic in infants with isolated hydronephrosis. MATERIALS AND METHODS: After screening 938 patients with prenatal hydronephrosis from 2009 to 2016 we selected 322 patients with ureteropelvic junction obstruction-like hydronephrosis for study. Hydronephrosis grades were prospectively collected at baseline, surgery and last followup. Gender, circumcision status, antibiotic prophylaxis and renal pelvis anteroposterior diameter were captured. The primary outcome was pyeloplasty and the development of febrile urinary tract infection. Comparative analyses between SFU grades/urinary tract dilatation groups and the primary outcome were performed with the Fisher exact and log rank tests. RESULTS: Mean ± SD age at presentation was 3.3 ± 2.6 months and mean followup was 22 ± 19 months. Pyeloplasty was performed in 32% of patients with SFU III/IV vs 31% with urinary tract dilatation 2/3. The rate of febrile urinary tract infection in patients with SFU III/IV was similar to that in those with urinary tract dilatation group 2/3 (8% vs 10%). Children with SFU III/IV showed a significantly higher rate of surgery than those with SFU I/II (32% vs 2%, p <0.01). Similar findings were seen when using urinary tract dilatation groups to compare patients at low risk (1) vs moderate/high risk (2/3). CONCLUSIONS: Both grading systems equally allowed for proper risk stratification and prediction of clinical outcomes based on baseline ultrasound. They correctly separated most infants who underwent surgery or in whom febrile urinary tract infection developed from those who could be treated nonsurgically. Use of the new urinary tract dilatation classification should not affect how families of children with isolated hydronephrosis are counseled regarding surgical intervention and the risk of febrile urinary tract infection.

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.

Side-to-Side Refluxing Nondismembered Ureterocystotomy: A Novel Strategy to Address Obstructed Megaureters in Children.

PURPOSE: A nonrefluxing megaureter is a relatively common cause of antenatal hydronephrosis. Although nonoperative management is favored, surgical intervention is sometimes warranted. However, there is controversy regarding the best approach, particularly in young children. We describe our experience with nondismembered side-to-side refluxing ureterocystotomy as a simple option to address obstruction. MATERIALS AND METHODS: Between January 2012 and January 2017, 32 patients underwent ureterocystotomy at 4 referral centers in North America. Demographics, surgical indications, complications, need for further interventions and change in hydronephrosis were captured. Patients were monitored clinically and with serial ultrasounds. RESULTS: Mean age at surgery was 3.7 months (range 0 to 33) and 25 (78%) patients were male. Unilateral procedures were performed in 29 patients. All patients were initially identified based on the presence of antenatal hydronephrosis and symptoms developed in 10. The procedure was conducted for primary nonrefluxing megaureter in 27 patients and to address secondary obstruction in the remainder. Mean followup was 34.3 months (range 6 to 58). At the most recent evaluation most children demonstrated significant improvement in dilation (86%). To date, 6 patients have undergone further procedures, including a circumcision and 2 ureteral reimplantations for recurrent infections. CONCLUSIONS: Our results suggest that side-to-side refluxing ureterocystotomy is a straightforward, minimally invasive alternative for the surgical management of nonrefluxing megaureter. Despite the trade-off of relieving obstruction and creating reflux, it can be considered a potentially definitive procedure in patients who remain infection-free, particularly circumcised boys. Extended followup with close monitoring is critical to document long-term results with this intervention.

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.

Lidocaine Gel for Urethral Catheterization in Children: A Meta-Analysis.

OBJECTIVE: To compare the efficacy and safety of lidocaine gel vs nonanesthetic gel (NAG) in reducing transurethral bladder catheterization (TUBC) procedural pain in children. STUDY DESIGN: A systematic literature search was done using electronic medical databases and trial registries up to September 2016 with no language restrictions. Randomized controlled trials (RCTs) that assessed the efficacy and safety of lidocaine gel vs NAG in reducing TUBC-associated pain in children were screened, identified, and appraised. Risks of bias and study quality of the eligible trials were assessed according to the Cochrane Collaboration recommendations. Various pain assessment scales from the included studies were extracted as mean differences and standard deviations for each treatment group. Standardized mean differences (SMDs) were generated with 95% CIs for between-group difference estimation. Effect estimates were pooled using the inverse variance method with a random-effects model. Subgroup analysis was performed for different age groups. RESULTS: Five RCTs (with a total of 369 children) were included. Overall pooled effect estimates showed that compared with NAG, lidocaine gel has no significant benefit in decreasing TUBC-associated pain in children (SMD, -0.22; 95% CI, -0.65 to 0.21). Effect estimates from 4 studies revealed no difference in pain reduction between the lidocaine gel and NAG in children aged <4 years (SMD, 0.01; 95% CI, -0.22 to 0.24). No serious adverse events from the lidocaine gel use were reported in any of the studies. CONCLUSIONS: Lidocaine gel does not appear to reduce TUBC pain compared with NAG, specifically in children aged <4 years. PROSPERO REGISTRATION NUMBER: CRD42016050018.

Users' guide to the surgical literature: how to assess an article using surrogate end points.

SUMMARY: Phase 3 randomized controlled trials are the widely accepted gold standard through which treatment decisions are made, as they assess the efficacy of a novel treatment against the control on the relevant patient population. The effectiveness of the novel treatment should be derived by measuring patient-important outcomes; however, to accurately assess these outcomes, clinical trials often require extensive patient follow-up and large sample sizes that can incur substantial expense. For this reason, investigators substitute surrogate end points to reduce the sample size and duration of a trial, ultimately reducing cost. The purpose of this article is to help surgeons appraise the surgical literature that use surrogate end points for patient-important outcomes.

Users' guide to the surgical literature: how to assess a noninferiority trial.

SUMMARY: A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin." In the last decade, we have observed an increase in the publication of noninferiority RCTs. This article explores this type of study design and discusses the tools that can be used to appraise such a study.