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BackgroundIntraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients.MethodsIn this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed.ResultsParticipants received pudexacianinium 0.3 mg (n = 3), 1.0 mg (n = 6), or 3.0 mg (n = 3). Most participants were female (n = 10; 83.3%); median age was 54 years (range 24–69) and median BMI was 29.3 kg/m2 (range 18.7–38.1). Successful intraoperative ureter visualization occurred in 2/3, 5/6, and 3/3 participants who received pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg, respectively. Median intensity values per surgeon assessment were 1 (mild) with the 0.3-mg dose, 2 (moderate) with the 1.0-mg dose, and 3 (strong) with the 3.0-mg dose. A correlation was observed between qualitative (surgeon’s recognition/identification of the ureter during surgery) and quantitative (video recordings of the surgeries after study completion) assessment of fluorescence intensity. Two participants experienced serious adverse events, none of which were drug-related toxicities. One adverse event (grade 1 proteinuria) was related to pudexacianinium. Plasma pudexacianinium concentrations were dose-dependent and the mean (± SD) percent excreted into urine during surgery was 22.3% ± 8.0% (0.3-mg dose), 15.6% ± 10.0% (1.0-mg dose), and 39.5% ± 12.4% (3.0-mg dose).ConclusionsIn this study, 1.0 and 3.0 mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.

To observe the efficacy and safety of retrograde intrarenal surgery (RIRS) combined with a flexible vacuum-assisted ureteral access sheath (FV–UAS) in patients with large renal stones (LRS). A total of 149 patients with LRS were prospectively randomized into two groups: 75 in the FV–UAS group and 74 in the minimally invasive percutaneous nephrolithotomy (MPCNL) group. The primary outcome was the stone-free rates (SFRs) on the first postoperative day. Secondary endpoints included the total SFRs 1 month postoperatively, lithotripsy time, hemoglobin reduction, length of postoperative hospital stay, quality of life (QoL) score improvement, incidence of ureteral stricture at 3 months postoperatively, and any surgery-related complications. Patient demographics and preoperative clinical characteristics showed no apparent difference between the two groups (all P  > 0.05). Postoperative data revealed a significantly longer lithotripsy time in the FV–UAS group than the MPCNL group (113.1 vs. 82.5 min, P  < 0.001). The mean decrease in hemoglobin was significantly lower in the FV–UAS group than in the MPCNL group (8.2 vs. 17.7 g/L, P  < 0.001). Similarly, the average hospital stay was shorter in the FV–UAS group than the MPCNL group (1.7 vs. 5.1 d, P  < 0.001). Meanwhile, SFRs on the first postoperative day and 1 month postoperatively were statistically similar between the two groups ( P  > 0.05). QoL improvement was significantly higher in the FV–UAS group than in the MPCNL group (33.4 vs. 26.9, P  < 0.001). The difference in ureteral stricture at 3 months postoperatively was not statistically significant ( P  > 0.05). Notably, the overall rate of postoperative complications was markedly lower in the FV–UAS group than in the MPCNL group ( P  < 0.05). Our study showed the safety and feasibility of applying RIRS combined with FV–UAS for LRS treatment, providing advantages such as high SFRs, minimal trauma, fast recovery, and low incidence of postoperative complications. It can be used as a clinical treatment alternative for LRS. The protocol for this study has been accepted by the Chinese Clinical Trial Registry (Ethics approval number: ChiCTR2200056402; Date of registration: 02-05-2022).

Urological complications after kidney transplantation, due to the ureteroneocystostomy, are associated with significant morbidity, prolonged hospital stay and even mortality. Ureteral stents can minimize the number of complications but are not consistently used, as previous studies were retrospective in nature. We aim to prospectively determine the most effective stenting approach. We performed a non-blinded single-centre randomised controlled trial in an academic hospital. Kidney transplant recipients were randomised to either a Single-J stent or a Double-J stent, removed according to respective protocols. Primary outcome was PCN placement within six months. Secondary outcomes encompassed urinary tract infections, cost-effectiveness, and hospital admission time. The study was conducted from November 2018 to August 2023, during which 300 recipients were included with complete follow-up. PCN was performed in 14.5% in the Single-J group (21/145) and 4.5% in the Double-J group (7/155), p = 0.003. Multivariable logistic regression, corrected for recipient age, BMI, sex, and donor type, showed an OR of 0.26 [0.10, 0.61] (OR [95%CI]). To prevent PCN in one recipient, 10 would have to receive the Double-J. All secondary outcomes were comparable, whereas hospital admission time and cost-effectiveness analysis heavily favoured Double-J stenting. An important limitation was that Single-J participants were unable to leave, even if their recovery allowed earlier discharge. This trial showed that Double-J stenting consistently reduced urological complications from 14.5% to 4.5%, while being highly cost-effective. Transplant surgeons should favour Double-J stenting to minimise the risk of complications.

Ureteral stents, such as double-J stents, have become indispensable in urologic procedures but are associated with complications like hematuria and pain. While the advancement of artificial intelligence (AI) technology has led to its increasing application in the health sector, AI has not been used to provide information on potential complications and to facilitate subsequent measures in the event of such complications. This study aimed to assess the effectiveness of an AI-based prediction tool in providing patients with information about potential complications from ureteroscopy and ureteric stent placement and indicating the need for early additional therapy. Overall, 28 patients (aged 20-70 years) who underwent ureteral stent insertion for the first time without a history of psychological illness were consecutively included. A \"reassurance-call\" service was set up to equip patients with details about the procedure and postprocedure care, to monitor for complications and their severity. Patients were randomly allocated into 2 groups, reassurance-call by AI (group 1) and reassurance-call by humans (group 2). The primary outcome was the level of satisfaction with the reassurance-call service itself, measured using a Likert scale. Secondary outcomes included satisfaction with the AI-assisted reassurance-call service, also measured using a Likert scale, and the level of satisfaction (Likert scale and Visual Analogue Scale [VAS]) and anxiety (State-Trait Anxiety Inventory and VAS) related to managing complications for both groups. Of the 28 recruited patients (14 in each group), 1 patient in group 2 dropped out. Baseline characteristics of patients showed no significant differences (all P>.05). Satisfaction with reassurance-call averaged 4.14 (SD 0.66; group 1) and 4.54 (SD 0.52; group 2), with no significant difference between AI and humans (P=.11). AI-assisted reassurance-call satisfaction averaged 3.43 (SD 0.94). Satisfaction about the management of complications using the Likert scale averaged 3.79 (SD 0.70) and 4.23 (SD 0.83), respectively, showing no significant difference (P=.14), but a significant difference was observed when using the VAS (P=.01), with 6.64 (SD 2.13) in group 1 and 8.69 (SD 1.80) in group 2. Anxiety about complications using the State-Trait Anxiety Inventory averaged 36.43 (SD 9.17) and 39.23 (SD 8.51; P=.33), while anxiety assessed with VAS averaged 4.86 (SD 2.28) and 3.46 (SD 3.38; P=.18), respectively, showing no significant differences. Multiple regression analysis was performed on all outcomes, and humans showed superior satisfaction than AI in the management of complications. Otherwise, most of the other variables showed no significant differences (P.>05). This is the first study to use AI for patient reassurance regarding complications after ureteric stent placement. The study found that patients were similarly satisfied for reassurance calls conducted by AI or humans. Further research in larger populations is warranted to confirm these findings. Clinical Research Information System KCT0008062; https://tinyurl.com/4s8725w2.

PurposeTo assess the safety and effectiveness of magnetic ureteric stent removal with a special magnet retriever under ultrasound guidance.MethodsA total of 60 male patients, who underwent ureteroscopy from October 2020 to March 2022, were prospectively enrolled and randomized into two groups. Group A patients underwent conventional double-J (DJ) stent insertion and subsequent stent removal via flexible cystoscopy. Group B patients underwent stent insertion using magnetic ureteric stent [Blackstar, Urotech (Achenmühle, Germany)] and stents were removed using a special magnet retriever under ultrasound guidance. Stents were left in situ for 30 days in both groups. All patients had follow-ups with a ureter stent symptoms questionnaire at 3- and 30-days post stent insertion. Visual analog scale (VAS) was assessed immediately after stent removal.ResultsStent removal time (142.5 s vs 142.5 s, group A vs group B, p < 0.0001) and VAS scores (4 vs 1, group A vs group B, p = 0.0008) were significantly lower in Group B. There were no statistically significant differences between both groups in the “urinary symptoms” (p = 0.3471) and “sexual matters” (p = 0.6126) in the USSQ domains. There was marginal statistical significance favoring Group A in the “body pain” (p = 0.0303), “general health score” (p = 0.0072), “additional problems” (p = 0.0142), and “work performance” (p < 0.0001) domains.ConclusionsMagnetic ureteric stent can be considered as a safe and efficient alternative to conventional DJ stent. This approach avoids the need for cystoscopy, saving resources while minimizing patient discomfort.

To assess the effect of co-trimoxazole and N-acetylcysteine (NAC), alone and in combination, on bacterial adherence to biofilm formed on ureteral stent surfaces. This prospective randomized study was conducted on 636 patients who underwent double J ureteral stent insertion after variable urological procedures. Patients were randomized into four groups: A (n = 165), no antibiotics or mucolytics during stent indwelling; B (n = 153), oral NAC (200 mg/day for children aged < 12 years old and 600 mg/day for adults) during stent indwelling; C (n = 162), oral co-trimoxazole (2 mg TMP/kg/day) during stent indwelling; and D (n = 156), both oral NAC and co-trimoxazole during stent indwelling. Two weeks following double J stent (JJ stent) insertion, urinalysis was performed on all patients and urine culture was done for all the patients at the day of double J stent removal. The stent was removed 2 weeks postoperatively, and a stent segment sized 3–5 cm from the bladder segment of the stent was sent for culture. Positive stent cultures were found in 63.6% (105/165), 43.1% (66/153), 37% (60/162), and 19.2% (30/156) patients of groups A, B, C, and D, respectively. E. coli was the organism most commonly isolated from the stent culture in all groups. The combination of co-trimoxazole and NAC was more effective in reducing bacterial adherence on ureteral stent surfaces than either alone.

Background The retrocaval ureter is a rare congenital anomaly resulting from abnormal development of the inferior vena cava. The obstruction is usually at the retrocaval segment of the ureter, as it lies between the inferior vena cava and the body of the third lumbar vertebra. Computed tomography intravenous urography is the gold standard for investigating this condition and can reveal ipsilateral hydronephrosis and the fishhook sign or sickle sign of the proximal ureter, depending on the type of retrocaval ureter. Case presentation We present the case of a 30-year-old African female who presented with intermittent dull right flank pain for 3 years. Computed tomography intravenous urography revealed isolated moderate right hydronephrosis with a fishhook sign in the proximal ureter. Surgical correction was performed, and the patient was followed for 6 months with improved renal function. Conclusion Surgery remains the sole definitive management of the retrocaval ureter for symptomatic patients and those with worsening hydronephrosis or differential renal function.

Purpose To compare stent-related symptoms (SRS) in patients with double J (DJ) undergoing substitution with a pigtail suture stent (PSS) after ureteroscopy (URS), through the Ureteral Stent Symptom Questionnaire (USSQ). Materials and methods Patients with DJ undergoing URS for stone treatment were enrolled in this prospective multicenter longitudinal study. The USSQ was submitted thrice: 2 weeks after DJ, 2 weeks after PSS and 4 weeks after PSS removal (baseline). Primary endpoint: to compare Urinary Symptom Index Score and the rate of patients with pain 2 weeks after DJ and PSS. Secondary endpoints: to compare other USSQ scores and single answers 2 weeks after DJ and PSS, and DJ and PSS USSQ scores with baseline. Results 93 patients were enrolled. 2 weeks Urinary Symptom Index Score ( p  < 0.001) and the percentage of patients complaining of pain (60.2% vs 88.2%, p  < 0.001) were significantly in favour of PSS compared to DJ. 2 weeks scores were significantly improved with PSS compared to DJ: Pain Index ( p  < 0.001), VAS ( p  < 0.001), General Health Index ( p  < 0.001) and Work Performance Index ( p  < 0.001). All urinary symptoms were significantly decreased with PSS, including renal pain during micturition and pain interfering with life. Pain Index Score ( p  = 0.622) and VAS ( p  = 0.169) were comparable to baseline with PSS, while differed with DJ. Conclusions Patients undergoing DJ substitution with PSS after URS report a significant decrease of SRS. Urologists may consider positioning PSS after URS in pre-stented patients to reduce the impact of SRS.

Although many ureteral stents are commercially available, the actuality of encrustation is yet to be elucidated in humans. This study compared the Tria Ureteral Stent with PercuShield and the Polaris Ultra Ureteral Stent with HydroPlus Coating for short-term encrustation formation. Eighty-four patients, who required ureteral stent placement after ureteroscopy, were randomized into two stent groups. After stent removal on postoperative day 14, the encrustation volume on the stent surface was measured by micro-computed tomography. The primary outcome was the inner luminal encrustation volume. Secondary outcomes were encrustation volume on the outer or total surfaces and occurrence of adverse events. Clinical factors related to encrustation were also assessed as a post-hoc analysis. Finally, of the 82 patients analyzed, 75 (91.5%) had encrustation in the inner lumen of the stent. The difference in median inner encrustation volume between the Tria and Polaris Ultra stents was comparable (0.56 vs. 0.37 mm 3 , P  = 0.183). There was no difference observed in the encrustation volume on the outer/total surfaces and stent-related adverse events. In both ureteral stents, the shaft body showed significant inner luminal encrustation compared to the proximal or distal loop (all, P  < 0.05). Dyslipidemia ( P  = 0.027), elevated urine pH ( P  = 0.046), and crystalluria ( P  = 0.010) were associated with encrustation formation. The Tria and Polaris Ultra stents had similar efficacy for preventing encrustation in the short-term. Further studies are required to compare their long-term patency.

This study evaluated the adherence of bacteria, calcium, and magnesium to three different ureteral stents after endoscopic surgery for urinary calculi. We randomly assigned 61 patients requiring the insertion of ureteral stents after urinary calculi treatment into three groups: Percuflex with a coating composition of Hydroplus ( n  = 21); Tria with a coating composition of Percushied ( n  = 22); and InLay Optima, which had a proprietary pHreeCoat coating ( n  = 18). All stents were removed and evaluated 1 month after treatment. The primary outcome was biomineral attachment to the ureteral stent. Calcium and magnesium contents were measured using atomic absorption spectrometry after the stent had been vortexed in a solution of saline and hydrochloric acid at pH 2. Bacteria were measured through flow cytometry of the washing solution collected by decantation after stent fragments had been immersed and vortexed in a saline solution. Median amounts of calcium and magnesium adhered to Percuflex were significantly higher than those adhered to Tria and InLay Optima. The median number of bacteria adhered was also highest in Percuflex compared to that in the other two groups, although without a statistically significant difference. These findings suggest that selecting stents with superior coating materials enhances patient outcomes and reduces stent-related complications.