Current Status of Pediatric Robot-Assisted Surgery in Italy: Epidemiologic National Survey and Future Directions.

Background: Pediatric robot-assisted surgery (RAS) is gaining increasing acceptance. We aimed to assess the diffusion of pediatric RAS in Italy, the training period, indications, preliminary outcomes, and limitations. Materials and Methods: An online questionnaire-based survey was performed. The data about robotic activity of 9 Italian Pediatric Surgery units were collected and analyzed. Results: Most of the participating centers (7/9, 77.8%) started RAS less than 5 years ago with only 2 centers (22.2%) performing RAS since 2010. The training included dry-lab in 5/9 centers (55.5%), wet-lab in 5/9 centers (55.5%), and robot simulator in 7/9 centers (77.8%), followed by an exam to obtain a certificate. The average duration of training was 23.7 hours (range 5-50). A total of 209 robotic procedures was performed in all centers during the period 2010-2018 and included 119 urological (56.9%), 31 gynecological (14.8%), 41 gastrointestinal (19.6%), 12 oncological (5.7%), and 6 other (2.8%) procedures. The docking time significantly fell down after 18 robotic procedures (P = .001). Intraoperative complications were recorded in 4 cases (1.9%). Conversion to laparoscopy was needed in 4 cases (1.9%) whereas conversion to open was required in 6 cases (2.8%). Postoperative complications occurred in 17/209 cases (8.1%) and were graded Clavien I-II in 14 cases (6.7%) and Clavien IIIb in only 4 cases (1.9%). Conclusions: Our study confirmed that RAS has still a limited diffusion in Italy for pediatric patients. Before starting robotic activity, pediatric surgeons have to obtain a certificate after a virtual and experimental training period. A mentorship clinical period of 10 cases under supervision of a proctor is also needed. The main indications in children remain reconstructive urological procedures. RAS is safe in children but its applications are currently limited to patients older than 2 years and with a weight >15 kg, due to the size of robotic ports.

The Discipline of Pediatric Urology: Prerogatives and Necessities.

To the Editor, The aim of this "position paper" is to describe the discipline of Pediatric Urology with its clinical and cultural competencies, represent the reasons for legitimizing its existence, and reinforce its importance in the "scenario" of the National Italian Healthcare System. The requisites and the educational requirements were defined by both the Italian Ministry of Health with the State-Regions Conference, and the European Union [...].

International Consultation on Incontinence 2016; Executive summary: Urodynamic testing.

AIMS: The International Consultation on Incontinence has published an update of the recommendations for the diagnosis and management of urine incontinence (ICI2016). This manuscript summarizes the consultations committee-recommendations with regard to urodynamic assessment. METHODS: Expert consensus on the basis of structured evidence assessment has been the basis of the consultations publication and has been summarized by the committee for this manuscript. RESULTS: Patients that are not satisfied with their initial management on the basis of their reported signs and symptoms of urinary incontinence, as well as all patients with neurological abnormalities that are potentially relevant for the function of the lower urinary tract, may very likely profit from objective diagnosis and staging and grading of their dysfunction, with urodynamic testing, regardless their age, vulnerability and/or comorbidities. The principles and technical innovations as well as the principal recommendations for the utilization of (invasive) urodynamic assessment for women, men, children, and vulnerable elderly, with or without neurogenic lower urinary tract dysfunction with urinary incontinence are provided in this abbreviated ICI recommendations-document. CONCLUSIONS: The ICI2016 committee on urodynamics presents an executive summary of the most important reasons and recommendations for the use of urodynamic investigations for patients with urinary incontinence.

Adolescence transitional care in neurogenic detrusor overactivity and the use of OnabotulinumtoxinA: A clinical algorithm from an Italian consensus statement.

AIMS: OnabotulinumtoxinA (onaBNTa) for treating neurogenic detrusor overactivity (NDO) is widely used after its regulatory approval in adults. Although the administration of onaBNTa is still considered off-label in children, data have already been reported on its efficacy and safety. Nowadays, there is a lack of standardized protocols for treatment of NDO with onaBNTa in adolescent patients in their transition from the childhood to the adult age. With the aim to address this issue a consensus panel was obtained. METHODS: A panel of leading urologists and urogynaecologists skilled in functional urology, neuro-urology, urogynaecology, and pediatric urology participated in a consensus-forming project using a Delphi method to reach national consensus on NDO-onaBNTa treatment in adolescence transitional care. RESULTS: In total, 11 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥70% of the experts agreed on recommendations. To facilitate a common understanding among all experts, a face-to-face consensus meeting was held in Rome in march 2015 and then with a follow-up teleconference in march 2017. By the end of the Delphi process, formal consensus was achieved for 100% of the items and an algorithm was then developed. CONCLUSIONS: This manuscript represents the first report on the onaBNTa in adolescents. Young adults should be treated as a distinct sub-population in policy, planning, programming, and research, as strongly sustained by national public health care. This consensus and the algorithm could support multidisciplinary communication, reduce the extent of variations in clinical practice and optimize clinical decision making.

Diagnosis and management of bladder bowel dysfunction in children with urinary tract infections: a position statement from the International Children's Continence Society.

BACKGROUND: We present a consensus view from the International Children's Continence Society (ICCS) on the evaluation and management of bladder bowel dysfunction (BBD) in children with urinary tract infection (UTI). The statement aims to highlight the importance of BBD in the development and recurrence of childhood UTI and its management to reduce its associated morbidity and sequelae. METHODS: A systematic literature search was done on PubMed, Embase, and Scopus databases until August 15, 2016. Relevant publications concerning BBD and its relationship with UTI among children were reviewed and aggregated for statements of recommendation. Discussion by the ICCS Board and a multi-disciplinary core group of authors resulted in a document available on its website for all ICCS members to review. Insights and feedback were considered with consensus and agreement reached to finalize this position statement. RESULTS: BBD in children with UTI is summarized. Details regarding epidemiology, pathophysiology, and recommendations for general and family practitioners and pediatricians relating to the evaluation and management of this condition are presented. CONCLUSIONS: This document serves as the position statement from ICCS, based on literature review and expert opinion providing our current understanding of BBD in children with UTI.

A Pediatric Case of Well-Functioning Supernumerary Kidney: Relative Renal Function Assessment Using Radionuclide Imaging.

We present an interesting image of a well-functioning supernumerary kidney evaluated with DMSA (dimercaptosuccinic acid) renal scintigraphy in a 14-year-old girl. At 2 years of age, the patient had a diagnosis of supernumerary kidney. She remained asymptomatic up to childhood age, and then a DMSA study was required to guide the following adequate surveillance strategy. DMSA study provided a clear imaging of supernumerary kidney in the left side of the abdomen showing a regular uptake and a normal function in relation to its own size.

Button Cystostomy: Is it Really a Safe and Effective Therapeutic Option in Pediatric Patients With Neurogenic Bladder?

OBJECTIVE: To define safety and effectiveness of cystostomy button in the management of bladder drainage in pediatric patients with neurogenic bladder, and report our personalized surgical technique. MATERIALS AND METHODS: This study is a retrospective analysis of patients undergoing cystostomy button placement for bladder drainage from October 2009 to December 2015. Endoscopic and open surgical techniques and medium-term complication were analyzed and indications were recorded. RESULTS: Thirty-five patients, 16 (45.7%) females and 19 (54.3%) males, underwent cystostomy button placement for bladder drainage with a mean age of 8.6 ± 4.8 years (standard deviation) and a mean follow-up time of 37 months. There were 91.4% of patients who had a neurogenic bladder; a nonobstructive urinary retention was diagnosed in the remainder of cases. A medium-term complication was mostly represented by urinary tract infection observed in 10 of 35 patients that was the most representative cause of button removal (4 of 35). Other observed complications were button leakage (n = 2), decubitus (n = 1), and bladder stone (n = 1). No postoperative complication was observed and no differences were found in terms of complications in the two surgical approaches performed. CONCLUSION: Cystostomy button is a safe and effective treatment for bladder drainage in neurogenic pediatric patients and it is also well accepted by patients and caregivers. Cystostomy button, which may avoid mechanical concerns and most of the social discomfort, should be considered an alternative method to other bladder drainage modalities.

A cost-of-illness study of spina bifida in Italy.

INTRODUCTION: Spina bifida (SB) is a congenital malformation of the spinal cord, nerves, and adjacent covering structures, with different levels of severity and functional disability. The economic cost of spina bifida and its prevention using folic acid have never been estimated in Italy. This study was conducted to define the cost of illness of SB in Italy. METHODS: A retrospective multicenter observational study on the social cost of patients with SB was carried out in three SB centers in Italy. Cost data were collected relating to the 12 months preceding the enrollment time (T0), and subsequently 3 months after the T0 time (±20 days) through a case report form designed to collect the relevant information on the costs incurred during the period considered. The data for all patients were analyzed through multivariate analysis on the main parameters. RESULTS: We enrolled 128 patients equally divided between males and females, with a mean age of 13 years (minimum, 0; maximum, 29). Diagnosis was mostly postnatal, with 64 cases diagnosed at birth and 33 cases diagnosed subsequently. The lesion severity levels, as defined in the inclusion criteria, were walking (52 patients); walking with simple orthoses (33 patients); walking with complex orthoses (16 patients); and nonwalking, (25 patients). The anatomic type identified is open SB in most cases (84 patients), followed by closed SB (37 patients) and SB occulta (3 patients). The most significant cost per year was for assistive devices, for a total of 4307.00 €, followed by hospitalization (907.00 €), examinations (592.00 €), and drug therapy (328.00 €). Cost breakdown by age range shows that the highest costs are incurred in the 0-4 age range. The highest cost was for cases of open SB (12,103.00 €). The cost/degree of severity ratio showed that the highest cost was for nonwalking patients (14,323.00 €), followed by patients walking with complex orthoses (13,799.00 €). CONCLUSION: The data from this study show that the mean total cost for a patient with SB was 11,351.00 € per year. Based on data provided by the Italian Institute of Health, we can estimate a total annual social cost of about 60 million Euros per year for SB in Italy. Cost of illness was correlated with age and degree of severity of SB.

Evaluation and treatment of nonmonosymptomatic nocturnal enuresis: a standardization document from the International Children's Continence Society.

PURPOSE: This document represents the consensus guidelines recommended by the ICCS on how to evaluate and treat children with nonmonosymptomatic nocturnal enuresis (NMNE). The document is intended to be clinically useful in primary, secondary and tertiary care. MATERIALS AND METHODS: Discussions were held by the board of the ICCS and a committee was appointed to draft this document. The document was then made available to the members of the society on the web site. The comments were vetted and amendments were made as necessary to the document. RESULTS: The main scope of the document is the treatment of NMNE with drugs other than desmopressin-based therapy. Guidelines on the assessment, and nonpharmacologic and pharmacologic management of children with NMNE are presented. CONCLUSIONS: The text should be regarded as an expert statement, not a formal systematic review of evidence-based medicine. It so happens that the evidence behind much of what we do in the care of enuretic children is quite weak. We do, however, intend to present what evidence there is, and to give preference to this rather than to experience-based medicine, whenever possible.

Long-term bladder function followup in boys with posterior urethral valves: comparison of noninvasive vs invasive urodynamic studies.

PURPOSE: We studied whether noninvasive urodynamic evaluation can be as effective and safe as invasive urodynamics in detecting lower urinary tract dysfunction and in preventing late onset renal failure during long-term management of boys with posterior urethral valves. MATERIALS AND METHODS: We evaluated 47 boys with posterior urethral valves using repeat urodynamics. A total of 28 patients with followup of at least 3 years and repeat evaluation of serum creatinine were included in the study. The first 14 boys in the series underwent cystometry and pressure-flow study at least every 3 years (group A), and the remaining 14 patients were monitored annually from age 5 with bladder diary, uroflowmetry, post-void residual urine on ultrasound and serum creatinine (group B). Lower urinary tract dysfunction and serum creatinine were compared (Fisher exact test and Mann-Whitney test) between groups A and B, and by stratifying patients into subgroups by age (5 to 6, 7 to 13 and older than 13 years). In all patients urodynamic diagnosis of lower urinary tract dysfunction was matched and confirmed with lower urinary tract symptoms. RESULTS: During followup the prevalence of lower urinary tract dysfunction did not differ significantly between group A (71% in boys 5 to 6, 43% in boys 7 to 13 and 85% in boys older than 13 years) and group B (36%, 43% and 60%, respectively). Late onset renal failure was observed in 2 boys in group A and 2 in group B. CONCLUSIONS: Noninvasive urodynamic evaluation seems to be as safe and effective as invasive urodynamic study in the long-term management of boys with posterior urethral valves. Based on these findings, invasive urodynamics may be reserved for cases of progressive deterioration of lower urinary tract dysfunction or renal function.

Female pelvic congenital malformations. Part II: sexuality, reproductive outcomes and psychological impact.

The second part of this review deals with the quality of life of patients with congenital pelvic malformations, focusing on the sexuality, reproductive outcomes and overall psychological impact of the women affected. The presence of deformed pelvic anatomy, congenital or iatrogenic, and therefore of altered urinary, anal or sexual functions, are not only a physical limitation but seriously compromise psychological health from childhood. These difficulties jeopardise the thorny path from childhood to adult life through adolescence, and if neglected, could be responsible for seriously impairing quality of life in adulthood, in terms of mental health and psychosocial functions. If, in the 1970s, the main objective was to save the lives of newborns/infants, nowadays the therapy concept looks beyond that, focusing on quality of life and aiming to establish a satisfactory sexual life, allow the possibility of becoming a parent and enable the successful psychosocial integration of the patient. Ensuring urinary and fecal continence as well as the possibility of normal sexual activity, are the basis for allowing a normal psychological growth during adolescence, which leads to a satisfactory life later on.

Female pelvic congenital malformations. Part I: embryology, anatomy and surgical treatment.

This review covers the most important female congenital pelvic malformations. The first part focuses on the embryological development of the urogenital and anorectal apparatus, morphological features, and the diagnostic and surgical approach to abnormalities. Comprehension of the embryological development of the urogenital and anorectal apparatus is essential to understand the morphology of congenital pelvic abnormalities and their surgical treatment. Congenital pelvic malformations are characterized by specific common features; the severity of which often subverts the pelvic morphology completely and makes it difficult to comprehend before surgery. The development of imaging, mainly magnetic resonance imaging and ultrasound, in the investigation of pelvic floor disorders has recently become a fundamental tool for surgeons to achieve better understanding of the anatomy. Forty years ago, the primary aim of clinicians was to save the lives of such patients and to achieve anatomical normality. However, nowadays, functional reconstruction and recovery are essential parts of surgical management. Introduction of minimally invasive surgery has allowed the improvement of cosmetic results that is so important in paediatric or adolescent patients after reconstructive surgery. The option of sharing the complexity of pelvic congenital diseases by entrusting specific competencies to subspecialists (paediatric urologists, urogynaecologists, neurourologists, paediatric endocrinologists and neonatologists) has improved the quality of care for patients. However, at the same time, active interaction between various specialists remains fundamental. The exchange of knowledge and expertise, not only during the diagnostic-therapeutic process but also during follow-up, is crucial to obtain the best anatomical and functional results throughout the life of the patient.

Effects of botulinum toxin type a in the bladder wall of children with neurogenic bladder dysfunction: a comparison of histological features before and after injections.

PURPOSE: Botulinum toxin type A has gained popularity in urology. Most reported studies have been in adults at urology centers and most have addressed long-term safety. Since botulinum toxin type A treatment for neurogenic bladder dysfunction requires repeat injections, verifying that such treatment does not induce fibrosis in children seems essential. MATERIALS AND METHODS: The study was approved by the institutional review board and patients were enrolled after we obtained written consent. Patients with neurogenic bladder dysfunction not responding to conventional treatment (anticholinergics and clean intermittent catheterization) were treated with 10 IU/kg botulinum toxin type A up to a maximum of 300 IU. Endoscopic cold cup biopsies were obtained from the posterolateral bladder wall 1.5 to 2 cm above the ureteral orifice. Bladder wall findings were categorized into 3 groups, including inflammatory infiltration, edema and fibrosis. Each criterion was then graded as mild or severe and analyzed by Fisher's exact test (p <0.05). RESULTS: A total of 46 bladder wall biopsies were obtained from 40 patients 2 to 18 years old. Biopsies were evaluated in groups 1 and 2, including group 1-20 from patients with no botulinum toxin type A injection and group 2-20 after botulinum toxin type A injection. Group 2 was subdivided into group 3-10 biopsies after 1 injection and group 4-10 after multiple injections. Six patients underwent biopsy twice, that is before the first and second treatments. Histological changes were present in all biopsies. When comparing groups 1 and 2, there was no statistically significant difference in inflammation and edema. However, there was a significant difference in fibrosis between groups 1 and 4 (p <0.05) with apparently decreased fibrosis after multiple injections. CONCLUSIONS: In our experience repeat botulinum toxin type A injections into the detrusor in children do not lead to increased fibrosis in the bladder wall. This study confirms the long-term safety of botulinum toxin type A in the pediatric population.

A simplified technique for botulinum toxin injections in children with neurogenic bladder.

PURPOSE: Botulinum toxin type A has revolutionized the treatment of neurogenic bladder dysfunction. The original injection technique used a rigid cystoscope and a flexible collagen needle. To date botulinum toxin type A injection techniques have not been standardized. We present our experience in pediatric patients using a new flexible injection system. MATERIALS AND METHODS: We treated 24 patients 3.8 to 17.5 years old who had neurogenic bladder dysfunction with botulinum toxin type A bladder and/or sphincter injection using a rigid cystoscope and the new N-DO™ endo-injector needle system. Another 24 patients 3.6 to 17.8 years old were treated with a 3.7Fr standard flexible needle and served as controls. Operative time, hospital stay, complications and efficacy were considered. Selection criteria and treatment were the same in the 2 groups. The 10 IU/kg dose was determined according to European Association of Urology guidelines. RESULTS: All patients received botulinum toxin type A bladder injection while 11 patients in the endo-injector group and 5 controls also received urethral injection. In the endo-injector needle and control groups average operative time was 12.4 and 17.3 minutes for the bladder, and 5.1 and 10.1 minutes for the urethra, respectively (each p <0.05). All patients were discharged home the day after the procedure. No complications were observed. Urodynamics revealed an average maximum detrusor pressure decrease of 25 and 21 cm H(2)O, and an average bladder capacity increase of 75 and 80 ml in the endo-injector and control groups, respectively (p not significant). CONCLUSIONS: While retaining efficacy, the endo-injector needle technique appears to be more rapid than the standard procedure for botulinum toxin type A injection for neurogenic bladder dysfunction. Whether patients may be treated with sedation only remains to be clarified.

Current state of nerve stimulation technique for lower urinary tract dysfunction in children.

PURPOSE: A variety of electrical nerve stimulation methods has been used through the years to treat lower urinary tract dysfunction. Relevant literature was reviewed to analyze techniques and available biomedical devices, technique applicability, indications and usefulness in pediatrics. MATERIALS AND METHODS: An extensive search was performed on PubMed® and MEDLINE® for scientific publications on intravesical, transcutaneous, sacral spine and root, and tibial nerve stimulation in children with lower urinary tract dysfunction of nonneurogenic and neurogenic origin. Relevant articles and controlled studies in adult patients were also considered. The search covered the period 1990 to 2009 and we found approximately 400 articles, of which 29 related to pediatrics. RESULTS: Due to feasibility problems with placebo studies the majority of the studies were noncontrolled, some of them clinical trials on acute urodynamic changes during electrical stimulation or experimental research in animals. Overall only a few randomized trials were found. Regarding types of electrostimulation and indications in children the recent literature emphasizes stimulation far from the anal-genital region, such as sacral transcutaneous electrical nerve stimulation, mainly for refractory overactive bladder. Intravesical stimulation is the procedure of choice to enhance sensation in patients with incomplete neurogenic lesions. Percutaneous tibial nerve stimulation is tolerated by children but has been poorly studied. Sacral neuromodulation using implanted devices remains questionable and needs further clarification of its indications. Magnetic stimulation has rarely been used in children to date. More experimental studies are needed to assess the method of action and refine the parameters of stimulation. CONCLUSIONS: Clinical controlled trials vs sham devices and predictable variables for successful response are urgently needed to address an apparently renewed focus on the use of nerve stimulation in the treatment of pediatric lower urinary tract symptoms.