Hydronephrosis

Hydronephrosis is a common congenital kidney anomaly. While most cases resolve on their own, some require surgery. Clinicians rely on repeated ultrasounds and sometimes invasive tests to decide if surgery is needed, but predicting outcomes is difficult. Researchers at SickKids developed an AI model that analyzes ultrasound images to assist in diagnosing and managing hydronephrosis. This study tests how well the AI integrates into real-world care. Clinicians will first make care decisions without AI and then review the AI's prediction before deciding whether to change their plan. A separate expert, unaware of whether AI influenced the first clinician's plan, will make the final decision to ensure care remains unchanged. The study will assess whether AI improves decision-making, reduces unnecessary tests, and fits into clinical workflows. If successful, the AI model could serve as a complementary tool to make diagnoses more efficient and precise while minimizing invasive procedures.

Hydronephrosis is common during pregnancy and is often physiological; however, it may also result from true obstruction requiring intervention. Differentiating between physiological and obstructive hydronephrosis remains a clinical challenge using conventional ultrasound. This prospective observational study aims to evaluate the diagnostic accuracy of renal cortical stiffness measured by shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis in pregnant women. Participants presenting with hydronephrosis will undergo clinical assessment, laboratory investigations, and ultrasound evaluation including SWE measurements. The diagnostic performance of SWE will be assessed using receiver operating characteristic (ROC) analysis, and optimal cut-off values will be determined. The study aims to provide a safe, non-invasive, and quantitative tool to improve diagnosis and guide management in pregnant patients with hydronephrosis.

The purpose of this clinical study is to evaluate the safety and efficacy of the Sten® Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This is a single-arm, open-label, prospective, non-randomized cohort study. Eligibility criteria for recruitment to this study included how to include labeling: (1) patients aged ≥18 years and ≤80 years, male and female; (2) patients who need to undergo upper urinary tract repair surgery; (3) patients who are suitable for ureteral reconstruction surgery as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or their guardian agreeing to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations. The research subjects of this project were recruited openly, and the patients were enrolled after being informed of the study-related information, risks and benefits by the project participants and then screened to meet the enrollment criteria. A total of 50 patients will be enrolled. The study objectives and endpoints include the following: primary endpoints: (1) the rate of surgical non-referral (2) the success rate of surgical treatment; secondary endpoints: (1) the loading time (2) the operating time of the surgeon (3) the estimated intraoperative blood loss (4) the postoperative patient's pain scores (5) the evaluation of the physiological load of the surgeon (6) the evaluation of the mental load of the surgeon (7) the rate of intraoperative transfusion (8) the duration of the hospital stay after the operation (9) the evaluation of physician satisfaction (9) the evaluation of physician's satisfaction). (9) Physician satisfaction rating (10) Overall postoperative complication rate (11) Adverse events and serious adverse events (12) Device defects (13) Postoperative readmission rate (14) Reoperation rate (15) Mortality rate. The expected overall duration is 9 months, with an expected enrollment time of 6 months and a subject follow-up time of approximately 3 months.

Renal pelvis dilatation can be a relatively common finding on obstetric antenatal ultrasounds occurring in 1% to 5% of all pregnancies, with a known predilection for the male sex. Fetal hydronephrosis can be ascribed to structural obstructive conditions or functional origin causes. The latter are characterized by the transience of the clinical picture, which appears milder in degree, onset at later gestational ages, a course of substantial stability and spontaneous regression, sometimes as early as during pregnancy or early postnatal life. Fetal hydronephrosis related to structural obstructive causes, on the other hand, classically presents an earlier onset, a worsening course during pregnancy and often requires postnatal surgical correction. Additional ultrasound findings that contribute to prognosis include those indicative of an associated congenital anomaly of the kidneys and urinary tract (CAKUT). The risk of postnatal pathology in mild prenatal hydronephrosis is reported to be between 11% and 15%. It increases up to 27-45% in fetuses with moderate prenatal hydronephrosis and up to 53- 88% in cases of severe hydronephrosis. In the outpatient clinical practice of prenatal ultrasonography, is hypothesized an association between mild, mono- bilateral fetal hydronephrosis as an isolated ultrasound finding and gestational diabetes. In this population, this study aims to highlight the stability of the sonographic picture, relative improvement with effective glycemic control with diet or medical therapy, and subsequent spontaneous resolution in early postnatal life. A possible causal link between the two conditions could lie in the association of poorly controlled gestational diabetes with fetal hyperglycemia, which would cause increased osmotic diuresis resulting in polyuria and subsequent hydronephrosis. In contrast, is hypothesized an association between earlier-onset moderate-to-severe fetal hydronephrosis, its worsening progression throughout pregnancy and the anatomic abnormalities finding in the fetal urinary tract, in no correlation with maternal gestational diabetes. This condition correlates with increased postnatal complications (e.g., recurrent urinary infections, need for antibiotic prophylaxis, etc.) and a more severe postnatal outcome that may require surgical correction. To date, there is limited scientific literature concerning the functional causes of fetal hydronephrosis, as opposed to obstructive causes, which have been more analyzed and classified. This ambispective observational case-control study aims to evaluate pregnant women accessing the obstetric ultrasound and obstetric day hospital outpatient clinics of the Fondazione Policlinico A. Gemelli- IRCCS with ultrasound finding of mono-bilateral fetal hydronephrosis during the second and third trimester of pregnancy. In this population we will define the fetal hydronephrosis degree, its evolution, the association with maternal metabolic disorders, in order to estimate postnatal morbidity. All prenatal ultrasound images will be interpreted by the same group of specialists. To assess the degree of fetal hydronephrosis, the classification system developed by SFU in 1993 will be used. The latter is the most commonly used among pediatric urologists for grading neonatal and infant pelvic disorders: * grade 0: no dilatation, calico walls paired with each other * grade 1 (mild): dilation of the renal pelvis without dilation of the calyces * grade 2 (mild): dilatation of the renal pelvis (mild) and calyces * grade 3 (moderate): moderate dilatation of the renal pelvis and calyces; dulling of the fornixes and flattening of the papillae; possible mild cortical thinning * grade 4 (severe): gross dilatation of renal pelvis and calyces; cortical thinning. The diagnosis of gestational diabetes will be defined by an altered oral glucose tolerance test (OGTT) result or elevated glycosylated hemoglobin (HBA1c) values. In addition, the presence of a flat OGTT trend suggestive of an insulin resistance condition will also be considered pathological. The OGTT will be performed between weeks 24 and 28 of pregnancy, as per the guidelines. In patients at high risk of developing gestational diabetes, early screening will be performed between sixteen and eighteen weeks of pregnancy. Amniotic fluid will be assessed according to one of the following ultrasound criteria: * calculation of amniotic fluid index (AFI) by summing the vertical depth of amniotic fluid measured in each quadrant of the uterus * With the single deepest pocket (SDP). Polydramnios is diagnosed when the amniotic fluid index (AFI) is ≥ 250 mm, the single deepest pocket (SDP) is ≥ 80 mm, or when the examiner subjectively assesses an increase in amniotic fluid. Oligohydramnios is diagnosed when the AFI is ≤ 50 mm or when the SDP is ≤ 20 mm.

To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.