62: Multicenter Collaboratives

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Kiersten M. Craig, MD, MSE 1  & Andrew C. Strine, MD, MPH 2
  1. Division of Pediatric Urology , Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
  2. Division of Pediatric Urology , Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

Introduction

The quality of research in pediatric urology is historically low due to a predominance of small retrospective studies at single centers. The rarity and complexity of many conditions create a challenge for high-quality research. While the feasibility of randomized controlled trials (RCTs) in the pediatric surgical literature is debated, the need for more prospective study design and multicenter collaboration is clear. A prospective study design decreases the potential for bias, while a multicenter collaboration allows for a larger sample size to increase the statistical power and more generalizability. A multicenter collaboration is also beneficial to share the workload for research, provide more educational and funding opportunities, and build a relationship with the participating centers through a shared experience. Furthermore, it can shift the referral patterns and build a practice, as referring providers as well as patients and families understand which centers have an expertise and are able to achieve an excellent outcome for a particular condition. However, a multicenter collaboration is not without its challenges, such as a significant commitment of time and resources as well as the need for leadership and coordination across multiple centers to complete the necessary tasks in a timely fashion. The purpose of this chapter is to review the recent multicenter collaboratives in pediatric urology in the United States (US), including those registered with the Societies for Pediatric Urology and others that have made a significant contribution. While there are numerous multicenter collaboratives in pediatric urology oncology, those are outside the scope for this chapter.

The Society for Fetal Urology

The SFU hydronephrosis registry is a prospective registry that was developed in 2006. Its objective is to study the natural history of prenatal hydronephrosis and to guide the management of these patients. The participating centers include Children’s Hospital of Richmond at Virginia Commonwealth University, Children’s Hospital of Orange County, Connecticut Children’s Medical Center, McMaster University, University of Iowa, University of Virginia, and University of Wisconsin.

Zee et al initially sought to assess the incidence and identify the risk factors for urinary tract infection (UTI) in a study of 213 patients with a prenatal diagnosis of hydronephrosis between September 2008 and October 2015. A total of 18 (8%) patients developed a UTI during the study period, most of which occurred during their first year of life (89%). Only a female sex (OR 8.4, 95% CI 2.8–24.7) was an independent predictor of UTI on multivariate analysis. When stratified by sex, both the grade of hydronephrosis (OR 8.3, 95% CI 1.1–61.9) and circumcision status (OR 23.2, 95% CI 2.2–238.9) were an independent predictor of UTI in male patients on multivariate analysis.1

In a subsequent study of 248 patients over the same period, Zee et al assessed the resolution of prenatal hydronephrosis after birth. The time to resolution favored a lower grade of hydronephrosis with a median follow-up of 15 months (IQR 7–24). A majority of hydronephrosis resolved or improved within 3 years, and surgical intervention was only required in 14 (8%) patients.2

Holzman et al also sought to determine the definition of clinically relevant hydroureter, its association with UTI, and the impact of continuous antibiotic prophylaxis (CAP) in a study of 237 patients with ureteral measurements on ultrasound between 2008–2020. Among patients who did not have vesicoureteral reflux (VUR) on voiding cystourethrogram, a ureteral diameter ≥7 mm was an independent predictor of UTI on multivariate analysis (HR 4.6, 95% CI 1.1–19.5). CAP was also significantly protective against UTI (HR 0.50, 95% CI 0.28–0.87).3

Chamberlin et al most recently assessed the incidence of UTI and impact of CAP in a study of 801 patients with a history of isolated prenatal hydronephrosis (no hydroureter) between 2008-2020. A total of 34 (4.2%) patients developed a UTI during the study period with a median follow-up of 1.6 years (IQR 0.85–2.7). A female sex (HR 13, 95% CI 3.8–44), circumcision status (HR 5.1, 95% CI 1.4–18), and SFU grade 3-4 hydronephrosis (HR 2.0, 95% CI 0.99–4.0) were each an independent predictor of UTI on multivariate analysis. The risk of UTI was not significantly different between those who received and did not receive CAP (4.0% vs. 4.3%) after adjusting for the sex, circumcision status, and grade of hydronephrosis on multivariate analysis (HR 0.72, 95% CI 0.34-1.5).4

National Spina Bifida Patient Registry

Due to differences in the staffing, delivery of services, and care in spina bifida clinics across the US, the Professional Advisory Council of the Spina Bifida Association developed the NSBPR at the Centers for Disease Control and Prevention in 2008. By providing the framework for a systematic approach to improve the quality of care, the NSBPR collects comparative data on demographics, treatments, and outcomes for children, adolescents, and adults ≥21 years of age who attend the 21 participating spina bifida clinics in the US.

Two studies have assessed the variation in the surgical managements of patients in the NSBPR. Routh et al assessed the surgical management of neurogenic bowel in a study of 5,528 patients enrolled in the NSBPR between 2009-2015. A total of 1,088 (19.7%) patients underwent a surgery for neurogenic bowel, including a Malone anterograde continence enema or cecostomy tube in 957 (17.3%) patients and an ileostomy or colostomy in 155 (2.8%) patients. An older age (p<0.001), female sex (p=0.02), white race (p=0.002), myelomeningocele (MMC) diagnosis (p=0.01), higher level of lesion (p<0.001), mobility status (p=0.01), private insurance (p=0.002), and NSBPR clinic (p<0.001) were each independently associated with an increased odds of surgery on multivariate analysis.5 Routh et al further assessed the surgical management of neurogenic bladder during the same study period. A total of 1,129 (20.4%) patients underwent a lower urinary tract reconstruction, including an augmentation cystoplasty in 703 (12.7%) patients, continent catheterizable channel in 382 (6.9%) patients, and bladder outlet procedure in 189 (3.4%) patients. The rates of lower urinary tract reconstruction widely varied from 12.1% to 37.9% among the NSBPR clinics. An older age, female sex, MMC diagnosis, mobility status, and NSBPR clinic (all p<0.0001) were each independently associated with an increased odds of surgery on multivariate analysis.6 Both studies observed a wide variation in surgical management based on both clinical- and non-clinical factors.5,6

Several studies have also assessed the bladder and bowel continence of patients in the NSBPR. In a study of 3,252 patients ≥5 years of age enrolled in the NSBPR between March 2009 and September 2012, Freeman et al reported that 1,326 (40.8%) patients were continent of urine with or without intervention during the day and that 1,398 (43.0%) patients had no involuntary leakage of stool with or without intervention during the day upon enrollment. The rates of bladder continence widely varied from 18.8% to 56.4% among the NSBPR clinics. An older age, female sex, race/ethnicity, private insurance, and NSBPR clinic were each independently associated with bladder continence for the entire cohort and those meeting the criteria for bladder impairment on multivariate analysis. The rates of bowel continence also widely varied from 17.2% to 65.0% among the NSBPR clinics. An older age, female sex, race/ethnicity, private insurance, and NSBPR clinic were each independently associated with bowel continence for the entire cohort and those meeting the criteria for bowel impairment on multivariate analysis. Both a sacral level of lesion when compared to a thoracic level (OR 1.60, 95% CI 1.12–2.20) as well as a non-ambulator when compared to a community ambulator (OR 0.76, 95% CI 0.58–0.99) were independently associated with bowel continence in the entire cohort. A non-MMC diagnosis was independently associated with bladder (OR 1.69, 95% CI 1.36–2.10) and bowel (OR 1.76, 95% CI 1.39–2.23) continence in the entire cohort as well.7 In a subsequent study of 5,250 patients ≥5 years of age enrolled in the NSBPR between 2009-2015, Lie et al assessed the bladder continence in a longitudinal fashion. By last follow-up, 1,178 (22.4%) patients underwent a lower urinary tract reconstruction, 4,833 (92.6%) patients used some form of bladder management, and 2,402 (45.8%) patients had no or less than 1 episode of daytime incontinence per month. An older age, female sex, race/ethnicity, non-MMC diagnosis, lower level of lesion, mobility status, and private insurance (all p<0.001) were each independently associated with bladder continence on multivariate analysis. Both a history of lower urinary tract reconstruction (OR 1.9, 95% CI 1.7–2.1) and any form of bladder management (OR 3.8, 95% CI 3.2–4.6) were also independently associated with bladder continence. The association between bladder management and continence was stronger for patients with a MMC diagnosis than those with a non-MMC diagnosis as well.8 Smith et al most recently focused on the ethnic disparities of bladder and bowel continence In a study of 4,364 patients between 5–21 years of age enrolled in the NSBPR between 2009–2015. By last follow-up, the Hispanic/Latino population had a significantly lower rate of private insurance (18.2% vs. 58.0%), lower urinary tract reconstruction (18.1% vs. 22.1%), surgery for neurogenic bowel (11.7% vs. 25.1%), bladder continence (38.6% vs. 44.9%), and bowel continence (43.9% vs. 55.8%) as well as a significantly higher rate of cutaneous vesicostomies (7.5% vs. 5.8%). A Hispanic/Latino ethnicity (OR 0.82, 95% CI 0.72–0.94) remained independently associated with a decreased odds of bowel continence on multivariate analysis.9

Two studies have specifically focused on adult patients in the NSBPR as well. Wiener et al assessed the bowel management and continence in a study of 5,209 patients ≥5 years of age enrolled in the NSBPR between September 2008 and December 2015. When compared to children between 5-11 years of age and adolescents between 12-19 yeas of age, the adult population was significantly less likely to use a Malone anterograde continence enema (17.1%) or cecostomy tube (5.5%) as well as more likely to use digital stimulation (4.4%) or disimpaction (3.0%) or have undergone a colostomy (3.9%). A total of 767 (58.3%) adults had no or less than 1 episode of bowel incontinence per month, including 630 (55.6%) adults with a MMC and 147 (74.9%) adults with a non-MMC diagnosis (p<0.0001). Only a lack of full or part-time employment (OR 0.59, 95% CI 0.42-0.83) was independently associated with bowel continence on multivariate analysis.10 Wiener et al further assessed the bladder management and continence during the same study period. When compared to children between 5-11 years of age and adolescents between 12-19 yeas of age, the adult cohort was significantly more likely to use CAP (17.4%) and perform CIC (76.8%) as well as less likely to use an anticholinergic medication (47.7%) and void spontaneously (10.5%). The types of lower urinary tract reconstruction also widely varied among the cohorts, including a significantly higher rate of augmentation cystoplasty in adults (23.0%). A total of 661 (48.2%) adults had no or less than 1 episode of daytime incontinence per month, including 543 (45.8%) adults with a MMC and 118 (63.1%) adults with a non-MMC diagnosis (p<0.0001). Bladder continence significantly improved with age in patients with a MMC (p<0.0001) but not in those with a non-MMC diagnosis (p=0.12). Again only a lack of full or part-time employment (OR 0.69, 95% CI 0.49-0.95) was independently associated with bladder continence on multivariate analysis.

Chu et al most recently assessed the surveillance of kidney function in a study of 5,445 patients registered in the NSBPR between 2013–2018. A total of 3,384 (62.1%) patients underwent at least 1 renal ultrasound and serum creatinine within 2 years of follow-up. The rates for surveillance of kidney function widely varied from 5.5% to 100% among the NSBPR clinics. A younger age (p<0.0001), level of lesion (p=0.001), less mobility status (p<0.0001), augmentation cystoplasty (p<0.0001), and NSBPR clinic (p<0.0001) were each independently associated with surveillance of kidney function on multivariate analysis. The NSBPR clinic remained an independent predictor for surveillance of kidney function in all sensitivity analyses, supporting a wide variation in practice.11

Multi-Institutional Bladder Exstrophy Consortium

MIBEC is a multicenter collaborative that was developed to increase the experience and proficiency in the care of bladder exstrophy among Boston Children’s Hospital, Children’s Hospital of Philadelphia, and Children’s Hospital of Wisconsin in 2013. Its objective is to refine the technical aspects and postoperative care for the complete primary repair of bladder exstrophy (CPRE) with the ultimate goal to decrease the complications and improve the long-term outcomes. Each center alternates as the host with observation, commentary, and critique by the visiting surgeons. High-definition video is used to record all surgeries and to facilitate a live local and distant broadcasting for real-time observation.12,13

Borer et al initially assessed the short-term outcomes in a series of 27 consecutive patients during the first 2 years of MIBEC. A total of 13 female and 14 males patients underwent a CPRE at a median age of 2.3 months (range 0.1–51.5). No dehiscences occurred, while the complications varied between male and female patients. A total of 6 female patients developed a complication (pyelonephritis in 5, urinary retention in 4, temporary CIC in 2, cutaneous vesicostomy in 1, and bladder rupture in 1), while 3 male patients developed a complication (urethrocutaneous fistula in 2, pyelonephritis in 1). They observed a higher rate of bladder outlet obstruction in female patients than previously reported in the literature but a comparably low rate of complications in male patients as well as early signs of continence and spontaneous voiding in both.12

Weiss et al also assessed the continence and dry intervals in a retrospective cohort study of 54 patients who underwent a CPRE prior to MIBEC between May 1993 and January 2013. A total of 35 (64.8%) patients were voiding per urethra, while 18 (33.3%) performed clean intermittent catheterization (CIC) and 1 underwent a cutaneous vesicostomy. Of those voiding per urethra, 25 (71.4%) patients did not require any secondary procedures for continence. A total of 26 (48.1%) patients were continent or had a dry interval of at 3 hours, including 11 (20.4%) that were truly continent with voiding per urethra. Only 9 (16.7%) patients were continent with voiding per urethra after a single surgery.13

Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida

UMPIRE is an iterative quality improvement protocol that was developed in 2014 to optimize the urologic management of patients with MMC from the newborn period to 5 years of age. Its objectives are to implement a standardized protocol for newborns with MMC across multiple centers, to determine the adherence to the protocol, to determine if the proposed protocol is optimal to maximize the urologic function while minimizing morbidity, to characterize the deviations from the protocol, and to determine its longitudinal impact on bladder and renal function. The participating centers include Duke Children’s Hospital & Health Center, Ann and Robert H. Lurie Children’s Hospital of Chicago, Children’s Hospital of Alabama, Children’s Hospital Los Angeles, Monroe Carrell Jr. Children’s Hospital at Vanderbilt University, Oregon Health Sciences University, Primary Children’s Hospital, Seattle Children’s Hospital, and Texas Children’s Hospital. The study design and protocol have been described previously.14

Tanaka et al initially assessed the baseline urinary tract imaging in a study of 193 infants with MMC between 2015–2018. A majority had normal or near normal imaging characteristics, including 2 normal kidneys in 105 (55.9%) patients and SFU grade 1-2 hydronephrosis in at least 1 kidney in 76 (40.4%) patients on renal and bladder ultrasound, no VUR in 154 (84.6%) patients on cystogram, and no renal defects in 61 (92.4%) patients and a difference in the differential renal function <15% in 62 (93.9%) patients on DMSA renal scan.15

Wallis et al also sought to assess the incidence and identify the risk factors for UTI in a study of 299 infants with MMC between February 2015 and August 2019. A total of 48 (16.1%) patients were treated for a UTI during the first 4 months of life. However, only 12 (4.0%) met the strict definition for UTI with an abnormal urinalysis (>10 WBC/HPF on urine microscopy and/or leukocyte esterase ≥2+ on dipstick), positive urine culture (≥100,000 CFU/mL of 1 or 2 speciated organisms), and at least 2 symptoms. Patients with SFU grade 3-4 hydronephrosis had a significantly higher risk of UTI compared to those with no hydronephrosis (RR 10.1, 95% CI 2.8–36.3), and patients on CIC had a significantly higher risk of UTI (RR 3.3, 95% CI 1.0–10.5). Patients who received no CAP beyond the perioperative period also had a non-statistically significantly lower risk of UTI (RR 0.5, 95% CI 0.1–2.1) and treatment for UTI (RR 0.6, 95% CI 0.3–1.1) than those who remained on CAP. They concluded that the incidence of UTI was low and questioned the necessity of routine CAP in newborns with MMC.16

Tanaka et al most recently assessed the baseline urodynamic findings at or before 3 months of age in a study of 157 patients with MMC between May 2015 to September 2017. There was a concurrence of only 50% for categorization of bladder hostility on primary review, which ultimately reached 100% with further standardization of interpretation. The categorization system was revised to group the “normal” and “safe” categories together as “low risk” as well as to exclude the diagnosis of detrusor-sphincter dyssynergia from the high-risk category due to unreliable measurement with surface patch electrodes. The final categorizations were low risk in 38 (24%) patients, intermediate risk in 96 (61%) patients, and high risk in 23 (15%) patients.17

Pediatric Urology Robotic Surgery

The PURS consortium is a multicenter collaborative that was developed at University of Chicago in 2015. Its objective is to assess the safety, feasibility, and efficacy of robot-assisted laparoscopic surgery as a comparable option to traditional open surgery in the pediatric population. The participating centers have varied over time and currently include University of Chicago, Children’s Healthcare of Atlanta, Children’s Hospital of Philadelphia, Cincinnati Children’s Hospital Medical Center, Riley Hospital of Children at Indiana University Health, Seattle Children’s Hospital, Texas Children’s Hospital, and Weill Cornell Medical College.

Avery et al initially assessed the outcomes and complications of robot-assisted laparoscopic pyeloplasty in a retrospective cohort study of 60 infants between April 2006 and July 2012. A total of 54 (92%) patients had an improved or resolved hydronephrosis, while 2 patients required additional surgery due to a recurrent obstruction. A total of 7 (11%) patients developed a complication. The mean operative time was 3 hours and 52 minutes (SD ±43 minutes). They concluded that the success and complication rates favorably compared with contemporary series of open and laparoscopic pyeloplasty in infants.18

The PURS consortium has assessed the outcomes and complications of robot-assisted laparoscopic extravesical ureteral reimplantation as well. Boysen et al conducted a retrospective cohort study of 260 patients (363 ureters) between 2005-2014. The cohort included 90 patients with complex anatomy, including 42 patients with a duplicated collecting system, 40 patients with a failed endoscopic Deflux injection, and 8 patients with a periureteral diverticulum. Of 280 ureters with a postoperative cystogram, 246 (87.9%) had a radiographic success. A total of 25 (9.6%) patients developed a complication, including 7 Clavien-Dindo grade 3 and no grade 4-5 complications. Four (3.9%) patients developed a transient urinary retention after a bilateral surgery.19 Boysen et al subsequently conducted a prospective cohort study of 143 patients (199 ureters) between 2015-2017. The cohort included a grade III-V VUR in 146 (73.4%) and complex anatomy in 59 (29.7%) ureters. Of 145 ureters with a postoperative cystogram, 136 (93.8%) had a radiographic success, including 97 (94.1%) with grade III-V VUR. A total of 16 (11.2%) patients developed a complication, including 8 Clavien-Dindo grade 3 and no grade 4-5 complications. Four (7.1%) patients developed a transient urinary retention after a bilateral surgery. The mean operative time was 194 minutes (SD ±62 minutes). They concluded that the success and complication rates favorably compared with contemporary series of open ureteral reimplantation.20

The PURS consortium has also published on 90-day complications of robot-assisted laparoscopic surgery, outcomes and complications of robot-assisted laparoscopic Mitrofanoff appendicovesicstomy, and outcomes and complications of robot-assisted laparoscopic ureterocalicostomy.21,22,23

Pediatric Urologists Researching Surgical Outcomes Using Health Information Technology

The PURSUIT network is a multicenter collaborative that was developed at Children’s Hospital Colorado in 2016. Its objective is to study the clinical outcomes and to define the best practices for management of patients with congenital anomalies of the kidney and urinary tract (CAKUT) through a prospective data collection using tools in the electronic health record (EHR). The participating centers include Children’s Hospital Colorado, Rady Children’s Hospital, Texas Children’s Hospital, University of Virginia Children’s Hospital, and Yale New Haven Children’s Hospital.

Vemulakonda et al initially sought to identify the clinical and demographic factors associated with infant pyeloplasty in a prospective cohort study of 197 infants <6 months of age with SFU grade 3-4 hydronephrosis between 2/1/2018 to 9/30/2019. They noted a significant variability in the rate of infant pyeloplasty among the participating centers as well as a similar rate of improved hydronephrosis over time for patients who were observed and underwent pyeloplasty. These findings suggested the need to standardize the evaluation and indications for pyeloplasty in infants with suspected ureteropelvic junction obstruction.24

Vemulakonda et al also assessed the feasibility of a standardized template for clinic visits in patients with congenital hydronephrosis and/or VUR. In a random sample of 230 infants between 1/1/2020 and 4/30/2021, they noted a high amount of agreement (>85%) between manual chart review and data extracted from the EHR.25

Pediatric Urology Midwest Alliance

PUMA is a regional multicenter collaborative that was developed among Ann & Robert H. Lurie Children’s Hospital of Chicago, Cincinnati Children’s Hospital Medical Center, Mayo Clinic, Nationwide Children’s Hospital, and Riley Hospital for Children at Indiana University Health in 2017.

To determine the feasibility of this collaborative, Szymanski et al initially assessed the probability of augmentation cystoplatsy or urinary diversion and CIC in a retrospective cohort study of 216 patients with classic bladder exstrophy between 1980 and 2016. They specifically focused on these outcomes due to their clinical relevance and reliable documentation in the medical records and performed a survival analysis to account for the lost to follow-up and varying ages of patients. Of 212 patients who underwent a primary closure, 108 (50.9%) patients underwent an augmentation cystoplasty and 10 (4.7%) patients underwent a urinary diversion. CIC was performed in 143 patients (67.4%) at the last follow-up, including 65 (85.5%) adults without a urinary diversion. The probability of augmentation cystoplasty or urinary diversion was 14.9% by 5 years of age, 50.7% by 10 years of age, and 70.1% by 18 years of age on survival analysis. Furthermore, the probability of augmentation cystoplasty or urinary diversion was 60.7% at 10 years after a bladder neck procedure on survival analysis. They concluded that these outcomes were much more common than previously reported in the literature.26

Using a similar approach, McLeod et al then assessed the risk of renal replacement therapy (RRT) and CIC in a retrospective cohort study of 274 patients with posterior urethral valves (PUV) who were treated within 90 days of life between 1995 and 2005. A total of 42 (15.3%) patients progressed to dialysis or renal transplantation. The nadir serum creatinine in the first year of life was the only independent predictor of RRT on multivariate analysis. After stratification by the nadir serum creatinine, the risk of RRT by 10 years was 0% for <0.4 mg/dL, 2% for 0.4-0.69 mg/dL, 27% for 0.7-0.99 mg/dL, and 100% for ≥1.0 mg/dL on survival analysis. CIC was also recommended in 60 (21.9%) patients in follow-up. The risk of CIC was 10% by 10 years of age and 50% by 14 years of age on survival analysis. A younger birth cohort from 2005-2015 (HR 15.3, 95% CI 4.6-51.1), nadir serum creatinine ≥1.0 mg/dL (HR 8.3, 95% CI 3.6-19.2), and anticholinergic use (HR 6.8, 95% CI 2.7-17.2) were each independently associated with risk of CIC on multivariate analysis. They concluded that the risk of RRT and CIC increased with age and that the nadir serum creatinine strongly predicted the need for RRT in the first year of life.27

Fuchs et al most recently assessed the long-term urinary and bowel management in a cross-sectional study of 160 patients with cloacal exstrophy or covered variants. A majority of patients were managed with CIC or incontinent urinary diversion. CIC was performed in 29 (83%) patients between 10-18 years of age and 46 (68%) adults, while an incontinent diversion was performed in 3 (9%) patients between 10-18 years of age and 19 (28%) adults. Only 14 (14%) patient were either catheterized or leaking per urethra, while no patients were voiding per urethra with a normal detrusor contraction and intact urinary sphincter. There was no significant difference in the age-adjusted odds of an incontinent urinary diversion among the participating centers or over time. A majority of patients were also managed with an intestinal diversion. An intestinal diversion was performed in 126 (79%) patients, while a pull-through was performed in the remaining 34 (21%) patients in addition to a Malone anterograde continence enema in 16 of these patients. The probability of an intestinal diversion varied significantly among the participating centers with a range of 55-91% but did not significantly change over time. Based on these unpromising results, they questioned the functional goals of patients with cloacal exstrophy and suggested that the reconstrucive surgeries by individualized accordingly.28

In concert with these efforts, PUMA has begun to study their patients with bladder exstrophy and PUV in a prospective fashion. They noted a significant variation in the management and outcomes of patients with PUV among the participating centers.29,30 They therefore developed a standardized clinical assessment and management plan by conducting a survey of pediatric urologists at the participating centers on their general practices and reviewing the available evidence.30 Selected surgeons also began to travel and observe the bladder exstrophy closures among the participating centers with the goal to refine the technical aspects of surgery and to promote an ongoing teaching, surgical coaching, and expertise. Kaefer et al described the use of intraoperative laser angiography to assess the real-time penile perfusion during various stages of closure.31

Prevention of Urinary Stones with Hydration (PUSH) Trial

The PUSH trial is a multicenter RCT (NCT03244189) on the use of behavioral interventions to increase and maintain a higher fluid intake for prevention of stones. The participating centers are in the Urinary Stone Disease Research Network, including Duke University (sponsor), Children’s Health Texas, Children’s Hospital of Philadelphia, Cleveland Clinic, Mayo Clinic, University of Pennsylvania, University of Texas Southwestern Medical Center, University of Washington, and Washington University in St. Louis. The study design and rationale as well as the challenges encountered during the COVID-19 pandemic have been described previously.32,33

The study has completed its enrollment of 1,658 patients and is scheduled to conclude in May 2024. Pediatric and adult patients ≥12 years of age were included with at least 1 symptomatic stone event within 3 years prior to enrollment or within 5 years if a new stone was detected on imaging. They also had a low 24-hour urine volume (defined as less than 2 L per day for patients ≥18 years of age and <25 mL/kg/day for patients <18 years of age). Patients were randomized in a parallel fashion to either an intervention or control arm. All patients received a smart water bottle to self monitor their fluid intake. Those in the intervention arm also underwent 3 behavioral interventions, including a fluid prescription for the additional water they must consume each day, randomly dispersed financial incentive when they reach their daily intake goal, and coaches to assist with overcoming their personal barriers to follow the fluid prescription. The primary outcomes include a stone passage and procedural intervention for a symptomatic or asymptomatic stone; while the secondary outcomes include the formation of new asymptomatic stone, growth of existing stone by >2 mm, 24-hour urine volumes, and cost of procedural interventions.32

Pediatric Urology Recovery after SUrgery Endeavor

PURSUE is a prospective, multicenter study (NCT03245242) on Enhanced Recovery After Surgery (ERAS) for lower urinary tract reconstruction with a possible bowel anastomosis in patients between 4–25 years of age. The participating centers include Ann & Robert H. Lurie Children’s Hospital of Chicago, Children’s Hospital Colorado, Children’s Hospital of Pittsburgh, Children’s Hospital of Richmond at Virginia Commonwealth University, Cincinnati Children’s Hospital Medical Center, Oklahoma Children’s Hospital, Seattle Children’s Hospital, and St. Louis Children’s Hospital. The study design and ERAS protocol have been described previously.34

The study has both a pilot and exploratory phase. The pilot phase is designed to assess the success with and barriers to implementation of ERAS in the first 5 patients at each center. The primary outcome is the protocol adherence with the goal of achieving a median of ≥70% protocol adherence per patient at ≥75% centers, while the secondary outcomes include the enrollment of ≥2 patients in the first 6 months of enrollment (to ensure a minimum level of experience with the ERAS protocol) and completion of 90 days of follow-up for the first 5 patients. For the exploratory phase, the enrolled patients will be propensity matched to historical controls in the 5 years prior to implementation of ERAS for comparison of outcomes. The primary outcome is the protocol adherence; while the secondary outcomes include the length of stay, emergency room visits, readmissions, reoperations, complications, pain scores, opioid usage, and differences in Quality of Recovery 9 scores.34

Moore et al most recently assessed the use of regional anesthesia in a subset of 158 patients with MMC who underwent a lower urinary tract reconstruction using an ERAS protocol between 2009 to 2021. Anesthesia setup significantly increased from a median 40 minutes (IQR 34-51) for patients who did not receive any regional anesthesia to 64 minutes (IQR 40-97) for patients who underwent the placement of regional catheters (p<0.01). However, the patients who underwent the placement of regional catheters had a significantly lower median intraoperative opioid use (0.24 vs 0.80 mg/kg morphine equivalents, p<0.01) and lower in-hospital postoperative opioid use (0.05 vs 0.23 mg/kg/day morphine equivalents, p<0.01) with no difference in pain scores. They concluded that patients with MMC benefited from regional anesthesia, despite the false perception of less postoperative pain due to their sensory deficits.35

Gonadoblastoma and Invasive Germ Cell Tumors

The registry is one of 2 open studies that are a part of the Pediatric Urology Oncology Working Group. Its objective is to assess the incidence of gonadoblastoma and GCTs in patients with DSD who underwent gonadectomy and to understand the oncologic outcomes for patients who developed a pre-malignant or malignant tumor. The study is actively recruiting participating centers and currently includes University of Kentucky, Children’s Hospital Colorado, and Children’s Hospital & Medical Center Nebraska.

Pediatric KIDney Stone Care Improvement Network

PKIDS is a care improvement network comprised of 26 pediatric healthcare systems. The network is conducting a prospective cohort study (NCT04285658) on the effectiveness of ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy for kidney and/or ureteral stones in patients between 8–21 years of age. Its objective is to improve the selection of surgical treatment options by incorporating patient-specific factors and outcomes. The executive committee includes Children’s Hospital of Philadelphia (sponsor), Children’s Hospital of Wisconsin, Cincinnati Children’s Hospital Medical Center, Boston Children’s Hospital, Ann & Robert H. Lurie Children’s Hospital of Chicago, and University of Pennsylvania. The conceptual framework and protocol have been described previously.36,37

Its enrollment began in February 2020 and is estimated to be completed in January 2024 with the goal of enrolling 1,290 patients. The primary outcome is the stone clearance (defined as absence of residual calculus >4 mm on postoperative ultrasound); while the secondary outcomes include several patient-experience outcomes (patient-reported physical, emotional, and social health outcomes), analgesic use, and use of healthcare resources.37

Western Pediatric Urology Consortium

WPUC is a regional multicenter collaborative that was developed at Children’s Hospital of Orange County in 2020. There are a total of 19 participating centers, including 3 in Canada, 2 in the eastern US, and the remaining in the western US.

Holzman et al initially assessed the impact of the COVID-19 pandemic on the presentation and management of acute testicular torsion in a study of 221 patients between 2 months and 18 years of age. The median time from the onset of symptoms to presentation significantly increased from 7.5 hours (IQR 4.0–28.0) in the 14 months prior to the COVID-19 pandemic to 17.9 hours (IQR 5.5–48.0) during the COVID-19 pandemic (p=0.04). The rate of orchiectomy had a corresponding increase from 40 (29%) patients to 34 (43%) patients, respectively (p=0.06).38

Yamashiro et al also sought to develop a surgical atlas of techniques for hypospadias repair by assessing the surgical volume and methods for recording operatve notes as well as the technical details for tubularized incised plate distal and proximal hypospadias repairs. A total of 24 (96.0%) surgeons at 12 centers recorded their operative notes in an EHR, of which 16 (66.7%) edited an existing template. They noted a significant variability with the use of surgeon-specific modifications for these 2 types of repairs.39

Traumatic Renal Injury Collaboration for Kids

TRICK is a multicenter collaborative that was developed for pediatric renal trauma in 2021. TRICK has presented at several national meetings but not published to date.

Lucas et al initially assessed the follow-up and recommendations for restriction of physical activity in a retrospective cohort study of 328 patients <18 years of age with grades III-V renal trauma at 5 level-1 pediatric trauma centers between 2007–2020. Follow-up occurred at a median of 30.0 days (IQR 11.0–56.0) after discharge with trauma surgery in 110 (33.5%) patients, with urology in 103 (31.4%) patients, and with nephrology in 15 (4.6%) patients. Only 184 (56.1%) patients received any recommendations for return to physical activity, which widely varied in the type of restriction and duration with a median of 5.0 weeks (IQR 2.0–6.0). These findings suggested the need to standardize the follow-up and recommendations for restriction of physical activity after high-grade renal trauma.40

In a subsequent retrospective cohort study of 345 patients <18 years of age with high-grade renal trauma over the same period, Lee et al assessed the impact of race and insurance status on their presentation, management, and outcomes. Caucasian patients presented at a significantly older age than African American patients and those with other races (p=0.001) and with a significantly lower rate of penetrating trauma than African American patients (p=0.002), but there was no differences in the rates of surgery, admission to the intensive care unit, complications, or mortality. Patients with public insurance also had a significantly higher injury severity score (p=0.02) and rate of blood transfusion (p=0.03) than those with private insurance, but there was again no differences in the rates of surgery, admission to the intensive care unit, complications, and mortality.41

Tong et al also assessed the utility of excretory-phase computerized tomography (EPCT) in a retrospective cohort study of 343 patients <18 years of age with high-grade renal trauma during the same period. Patients who underwent an EPCT were significantly more likely to undergo the placement of ureteral stent than those who underwent a non-EPCT (p=0.009), but there was no difference in the length of hospitalization or the rates of delayed imaging, delayed surgical or radiologic intervention, complications, readmissions, or mortality. These findings questioned the utility of EPCT for high-grade renal trauma and suggested the need for additional research to identify those who may benefit from multi-phase CT.42

Flores et al most recently assessed the utility of repeat CT in a retrospective cohort study of 84 patients <18 years of age with isolated grade IV-V renal trauma between 2007–2022. There was no difference in the rates of delayed surgical or radiologic intervention, complications, readmissions, or mortality in patients who underwent a repeat CT and those who underwent no imaging or only a renal ultrasound. These findings questioned the utility of repeat CT for high-grade renal trauma and suggested the need for pediatric-specific guidelines.43

Table 1 Summary of Multicenter Collaboratives in Pediatric Urology

Name Topic Date of Origin Principal Investigator(s) Website
Gonadoblastoma and invasive GCT in DSD GCT in DSD 2017 Amanda F. Saltzman and Nicholas G. Cost PUOWG Studies
MIBEC CPRE for bladder exstrophy 2013 Center specific  
NSBPR Spina bifida 2008 Center specific PURSUE
PKIDS Network Surgical management of urolithiasis 2020 Gregory E. Tasian PKIDS Network
PUMA Varied 2017 Study specific PUMA
PURS Consortium Robot-assisted laparoscopic surgery 2015 Mohan S. Gundeti  
PURSUE ERAS for lower urinary tract reconstruction 2017 Kyle O. Rove PURSUE
PURSUIT Network CAKUT 2016 Vijaya M. Vemulakonda  
PUSH Trial Fluid intake for urolithiasis 2017 Charles D. Scales PUSH Trial
SFU Hydronephrosis Registry Prenatal hydronephrosis 2006 C.D. Anthony Herndon  
TRICK Renal trauma 2021 Center specific  
UMPIRE Protocol for urologic management of spina bifida 2014 Center specific UMPIRE
WPUC Varied 2020 Anthony E. Khoury  

Conclusion

Many multicenter collaboratives have recently developed in the US on a wide variety of topics in pediatric urology. They have generally been of higher quality with a majority having a large sample size and prospective study design. These types of multicenter collaboratives are critical to advancing the field of pediatric urology.

Key Points

  • The quality of research in pediatric urology is historically low due to a predominance of small retrospective studies at single centers.
  • A multicenter collaboration has a multitude of advantages, including a larger sample size to increase the statistical power (which is particularly important for rare and complex conditions), more generalizability, more evenly distributed workload for research, educational and funding opportunities, building a relationship with the participating centers, and building an area of expertise.
  • Many multicenter collaboratives have recently developed in the US with a higher-quality study design on a wide variety of topics in pediatric urology.

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