Background: Selecting an appropriate procedure to simultaneously treat patients with concomitant ureteropelvic junction obstruction (UPJO) and renal stones in children remains a challenge. The aim of this retrospective study was to investigate the safety and feasibility of laparoscopy pyeloplasty with adjunct flexible ureteroscopy (FURS) for treating children with UPJO and renal calyceal stones.
Methods: 38 children with UPJO and renal calyceal stones who underwent laparoscopy pyeloplasty with adjunct FURS between January 2013 and December 2022 at our institution were retrospectively reviewed. All the patients were preoperatively diagnosed and followed up based on clinical presentation, urine analysis, ultrasonography, intravenous pyelography, magnetic resonance urography, and diuretic renography using a Tc-99m mercaptoacetyltriglycine scan. Preoperative clinical data and outcomes were analyzed for the initial experience of laparoscopy pyeloplasty with adjunct FURS in children.
Results: This study included 26 males and 12 females, with 17 patients having UPJO in the left kidney and 21 in the right kidney. The age range was from 3 to 10 years, with a mean age of 5.3 years. All procedures were successful without conversion to open surgery. The mean procedure time was 138.1 min (119-163 min), the mean time to drain removal was 2.3 ± 0.9 days (1 to 4 days), the mean time to commencement of oral feeding was 1.4 ± 0.5 days (1 to 2 days), and the mean duration of hospitalization was 7.5 ± 1.8 days (6 to 11 days). Ultrasonography and magnetic resonance urography revealed that, for all patients, the renal pelvis anteroposterior diameter regressed, the thickness of the renal parenchyma increased, and no residual fragments were observed. Diuretic renograms showed T1/2 < 20 min for all patients, and no obstructions were observed.
Conclusion: Laparoscopy pyeloplasty with adjunct FURS is feasible and safe for the treatment of pediatric patients with UPJO and renal calyceal stones.
背景:选择合适的手术同时治疗儿童肾盂输尿管交界处梗阻(UPJO)和肾结石患者仍然是一个挑战。本回顾性研究的目的是探讨腹腔镜肾盂成形术联合柔性输尿管镜(FURS)治疗儿童UPJO和肾盏结石的安全性和可行性。方法:回顾性分析2013年1月至2022年12月在我院行腹腔镜肾盂成形术并合并肾盂肾结石的38例儿童。所有患者术前均根据临床表现、尿液分析、超声、静脉肾盂造影、磁共振尿路造影及Tc-99m巯基乙酰三甘氨酸扫描利尿肾造影进行诊断和随访。术前临床资料和结果分析初步经验腹腔镜肾盂成形术与辅助FURS的儿童。结果:本研究纳入男性26例,女性12例,其中左肾UPJO 17例,右肾UPJO 21例。年龄3 ~ 10岁,平均5.3岁。所有手术均成功,未转为开放手术。平均手术时间138.1 min (119 ~ 163 min),平均拔管时间2.3±0.9 d (1 ~ 4 d),平均开始口服喂养时间1.4±0.5 d (1 ~ 2 d),平均住院时间7.5±1.8 d (6 ~ 11 d)。超声及磁共振尿路造影显示,所有患者肾盂前后径变大,肾实质厚度增加,未见残留碎片。结论:腹腔镜肾盂成形术辅助FURS治疗儿童UPJO合并肾盏结石是可行且安全的。
{"title":"Initial experience with combined laparoscopic pyeloplasty with adjunct flexible ureteroscopy for management of ureteropelvic junction obstruction with renal calyceal stones in children: a retrospective study.","authors":"Tengfei Lu, Pin Li, Bojian Li, Lifei Ma, Tian Tao, Xiaoguang Zhou, Huixia Zhou, Dehong Liu","doi":"10.1007/s11255-026-05046-y","DOIUrl":"https://doi.org/10.1007/s11255-026-05046-y","url":null,"abstract":"<p><strong>Background: </strong>Selecting an appropriate procedure to simultaneously treat patients with concomitant ureteropelvic junction obstruction (UPJO) and renal stones in children remains a challenge. The aim of this retrospective study was to investigate the safety and feasibility of laparoscopy pyeloplasty with adjunct flexible ureteroscopy (FURS) for treating children with UPJO and renal calyceal stones.</p><p><strong>Methods: </strong>38 children with UPJO and renal calyceal stones who underwent laparoscopy pyeloplasty with adjunct FURS between January 2013 and December 2022 at our institution were retrospectively reviewed. All the patients were preoperatively diagnosed and followed up based on clinical presentation, urine analysis, ultrasonography, intravenous pyelography, magnetic resonance urography, and diuretic renography using a Tc-99m mercaptoacetyltriglycine scan. Preoperative clinical data and outcomes were analyzed for the initial experience of laparoscopy pyeloplasty with adjunct FURS in children.</p><p><strong>Results: </strong>This study included 26 males and 12 females, with 17 patients having UPJO in the left kidney and 21 in the right kidney. The age range was from 3 to 10 years, with a mean age of 5.3 years. All procedures were successful without conversion to open surgery. The mean procedure time was 138.1 min (119-163 min), the mean time to drain removal was 2.3 ± 0.9 days (1 to 4 days), the mean time to commencement of oral feeding was 1.4 ± 0.5 days (1 to 2 days), and the mean duration of hospitalization was 7.5 ± 1.8 days (6 to 11 days). Ultrasonography and magnetic resonance urography revealed that, for all patients, the renal pelvis anteroposterior diameter regressed, the thickness of the renal parenchyma increased, and no residual fragments were observed. Diuretic renograms showed T<sub>1/2</sub> < 20 min for all patients, and no obstructions were observed.</p><p><strong>Conclusion: </strong>Laparoscopy pyeloplasty with adjunct FURS is feasible and safe for the treatment of pediatric patients with UPJO and renal calyceal stones.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: To evaluate whether combining microdissection testicular sperm extraction (microTESE) with trifocal testicular sperm extraction (TESE) in a single session improves sperm retrieval and cryopreservation outcomes in men with nonobstructive azoospermia.
Materials and methods: Retrospective cohort study of 93 men with nonobstructive azoospermia (out of 176 consecutive men with azoospermia) who underwent both microTESE and trifocal TESE sequentially during the same procedure was analyzed. Specimens from each technique were processed and analyzed separately to enable within-patient comparison. Sperm retrieval rates, quantitative sperm yield, and cryopreserved vials were measured. Histopathological patterns were classified. Statistical significance was set at p < 0.05.
Results: Sperm retrieval was successful in 59 of 93 patients, resulting in an overall retrieval rate of 63.4%. When analyzed separately, spermatozoa were identified in microTESE specimens from 54 patients (58.1%) and in trifocal TESE specimens from 51 patients (54.8%). The combined approach (analyzing all specimens from both techniques) achieved a significantly higher retrieval rate (63.4%) than either technique analyzed alone (p = 0.041 vs. microTESE; p = 0.002 vs. trifocal TESE). In seven patients (7.5%), sperm were found exclusively in microTESE specimens, and in three patients (3.2%), exclusively in trifocal specimens. Quantitative sperm yield was also higher with the combined approach (mean ± SD: 9.9 ± 5.1 sperm units) than with either microTESE (3.9 ± 3.2) or trifocal TESE (6.0 ± 3.4) specimens alone (p < 0.001). This resulted in more cryopreserved vials (12.4 ± 2.4 vs. 5.9 ± 1.2, p < 0.001), enabling greater fertility preservation potential. Histopathological analysis revealed a mixed atrophy pattern in all successful retrievals, supporting the biological rationale for combining targeted and systematic sampling in patients with focal spermatogenesis.
Conclusion: A dual technique approach combining microTESE and trifocal TESE significantly improves sperm retrieval rates and cryopreservation outcomes in nonobstructive azoospermia compared to either technique alone. This strategy maximizes fertility preservation and may reduce the need for repeat testicular procedures.
目的:评价显微解剖睾丸精子提取(microTESE)与三焦睾丸精子提取(TESE)单次联合应用是否能改善非阻塞性无精子症男性的精子提取和冷冻保存效果。材料和方法:回顾性队列研究分析了93名非阻塞性无精子症男性(来自176名连续无精子症男性)在同一手术期间先后接受了显微TESE和三灶TESE。每种技术的标本分别进行处理和分析,以便进行患者内部比较。测量精子回收率、定量精子产量和冷冻保存瓶。组织病理模式进行分类。结果:93例患者中有59例成功取精,总取精率为63.4%。单独分析时,54例(58.1%)患者的显微TESE标本和51例(54.8%)患者的三灶性TESE标本中发现了精子。联合方法(分析来自两种技术的所有标本)获得的检索率(63.4%)明显高于单独分析任何一种技术(p = 0.041 vs. microTESE; p = 0.002 vs.三焦点TESE)。在7名患者(7.5%)中,精子仅在微灶标本中发现,在3名患者(3.2%)中,精子仅在三灶标本中发现。与单独使用microTESE(3.9±3.2)或三焦TESE(6.0±3.4)标本相比,联合使用microTESE和三焦TESE的双技术方法可显著提高非阻塞性无精子症患者的精子恢复率和冷冻保存结果(平均±SD: 9.9±5.1精子单位)。这种策略最大限度地保留生育能力,并可能减少重复睾丸手术的需要。
{"title":"Combining microTESE and trifocal TESE improves sperm retrieval and cryopreservation outcomes in nonobstructive azoospermia.","authors":"Shimi Barda, Noga Fuchs Weizman, Ron Hauser, Haggar Zoe Aspitz, Hadar Amir, Yael Kalma, Ofer Lehavi, Sandra Edith Kleiman, Foad Azem, Snir Dekalo","doi":"10.1007/s11255-026-05037-z","DOIUrl":"https://doi.org/10.1007/s11255-026-05037-z","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate whether combining microdissection testicular sperm extraction (microTESE) with trifocal testicular sperm extraction (TESE) in a single session improves sperm retrieval and cryopreservation outcomes in men with nonobstructive azoospermia.</p><p><strong>Materials and methods: </strong>Retrospective cohort study of 93 men with nonobstructive azoospermia (out of 176 consecutive men with azoospermia) who underwent both microTESE and trifocal TESE sequentially during the same procedure was analyzed. Specimens from each technique were processed and analyzed separately to enable within-patient comparison. Sperm retrieval rates, quantitative sperm yield, and cryopreserved vials were measured. Histopathological patterns were classified. Statistical significance was set at p < 0.05.</p><p><strong>Results: </strong>Sperm retrieval was successful in 59 of 93 patients, resulting in an overall retrieval rate of 63.4%. When analyzed separately, spermatozoa were identified in microTESE specimens from 54 patients (58.1%) and in trifocal TESE specimens from 51 patients (54.8%). The combined approach (analyzing all specimens from both techniques) achieved a significantly higher retrieval rate (63.4%) than either technique analyzed alone (p = 0.041 vs. microTESE; p = 0.002 vs. trifocal TESE). In seven patients (7.5%), sperm were found exclusively in microTESE specimens, and in three patients (3.2%), exclusively in trifocal specimens. Quantitative sperm yield was also higher with the combined approach (mean ± SD: 9.9 ± 5.1 sperm units) than with either microTESE (3.9 ± 3.2) or trifocal TESE (6.0 ± 3.4) specimens alone (p < 0.001). This resulted in more cryopreserved vials (12.4 ± 2.4 vs. 5.9 ± 1.2, p < 0.001), enabling greater fertility preservation potential. Histopathological analysis revealed a mixed atrophy pattern in all successful retrievals, supporting the biological rationale for combining targeted and systematic sampling in patients with focal spermatogenesis.</p><p><strong>Conclusion: </strong>A dual technique approach combining microTESE and trifocal TESE significantly improves sperm retrieval rates and cryopreservation outcomes in nonobstructive azoospermia compared to either technique alone. This strategy maximizes fertility preservation and may reduce the need for repeat testicular procedures.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: To evaluate the feasibility and outcomes of membrane-guided total intracorporeal laparoscopic reconstruction for ureteral avulsion (UA) following ureteroscopic lithotripsy.
Materials and methods: From January 2021July 2025, eight patients with UA secondary to ureteroscopic lithotripsy underwent membrane-guided total intracorporeal laparoscopic reconstruction. Five patients were treated with the Boari flap technique (BFT), and three underwent ileal ureter replacement combined with Boari flap-psoas hitch (IURBFPH). Preoperative evaluations to assess the ureteral defects included anterograde urography and computed tomography urography (CTU). For all procedures, the membranes were considered during gastrointestinal mobilization and ureteral defect preparation. The postoperative follow-up examinations included urological ultrasound, CTU, and clinical symptom assessment.
Results: All eight reconstructions were successfully completed intracorporeally without conversion to open surgery. The median length of the UA was 6.50 cm (range: 3.00-18.00 cm). The mean operative time was 362.00 min (range: 240.00-515.00 min), with an estimated blood loss volume of 75.00 ml (range: 20.00-400.00 ml). The mean postoperative length of hospital stay was 12.88 days (range: 7.00-18.00 days). No serious complications or progressive hydronephrosis were observed during a mean follow-up of 9.39 months (range: 1.00-35.00 months), and the success rate was 100%.
Conclusions: The preliminary findings from this case series demonstrate that membrane-guided total intracorporeal laparoscopic reconstruction may be a feasible alternative approach for managing UA secondary to ureteroscopic lithotripsy. However, longer-term functional assessments are warranted.
{"title":"Is membrane-guided total intracorporeal laparoscopic reconstruction a viable therapeutic alternative for ureteral avulsion following ureteroscopic lithotripsy?","authors":"Guohao Wu, Yiqi Lai, Haomin Li, Feng Luo, Handa Zheng, Qiyu Zhong, Jiahui Chen, Qiao Lv, Jiansheng Xiao, Lishan Xie, Huilan Luo, Zhihui Chen, Zheng Chen, Dongming Ye, Xuesong Li, Caiyong Lai","doi":"10.1007/s11255-026-05020-8","DOIUrl":"https://doi.org/10.1007/s11255-026-05020-8","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the feasibility and outcomes of membrane-guided total intracorporeal laparoscopic reconstruction for ureteral avulsion (UA) following ureteroscopic lithotripsy.</p><p><strong>Materials and methods: </strong>From January 2021July 2025, eight patients with UA secondary to ureteroscopic lithotripsy underwent membrane-guided total intracorporeal laparoscopic reconstruction. Five patients were treated with the Boari flap technique (BFT), and three underwent ileal ureter replacement combined with Boari flap-psoas hitch (IURBFPH). Preoperative evaluations to assess the ureteral defects included anterograde urography and computed tomography urography (CTU). For all procedures, the membranes were considered during gastrointestinal mobilization and ureteral defect preparation. The postoperative follow-up examinations included urological ultrasound, CTU, and clinical symptom assessment.</p><p><strong>Results: </strong>All eight reconstructions were successfully completed intracorporeally without conversion to open surgery. The median length of the UA was 6.50 cm (range: 3.00-18.00 cm). The mean operative time was 362.00 min (range: 240.00-515.00 min), with an estimated blood loss volume of 75.00 ml (range: 20.00-400.00 ml). The mean postoperative length of hospital stay was 12.88 days (range: 7.00-18.00 days). No serious complications or progressive hydronephrosis were observed during a mean follow-up of 9.39 months (range: 1.00-35.00 months), and the success rate was 100%.</p><p><strong>Conclusions: </strong>The preliminary findings from this case series demonstrate that membrane-guided total intracorporeal laparoscopic reconstruction may be a feasible alternative approach for managing UA secondary to ureteroscopic lithotripsy. However, longer-term functional assessments are warranted.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-10DOI: 10.1007/s11255-026-05048-w
Stanislav Vovdenko, Igor Kuznetsov, Sabukhi Amrakhov, Mikhail Chernenkiy, Ivan Chernenkiy, Alexandra Proskura, Agabek Zholdubaev, Khalil Ismailov, Andrey Vinogradov, Dmitriy Fiev, Evgeny Sirota, Evgeny Shpot, Yuriy Alyaev, Petr Glybochko
Background: About 30-40% of patients with renal-cell carcinoma experience recurrence within 5 years after partial nephrectomy despite current prognostic scoring systems. Radiomic analysis of preoperative CT images has the potential to offer improved risk stratification when compared with conventional clinicopathological variables.
Objective: To identify radiomic and clinical prognostic features associated with RCC recurrence after partial nephrectomy and to develop an integrated machine learning model for enhanced recurrence risk stratification.
Methods: The retrospective study included 190 RCC patients who underwent laparoscopic partial nephrectomy from 2011 to 2022. Preoperative contrast-enhanced CT scans were analyzed using radiomic feature extraction. Analyzed clinical variables included age, BMI, nephrometry scores (RENAL, PADUA, Centrality index), and tumor volume. Three machine learning algorithms (Random Forest, Gradient Boosting, and Logistic Regression) were trained to predict recurrence, with SHAP analysis for feature importance evaluation.
Results: The Gradient Boosting model achieved the highest predictive performance with ROC-AUC of 0.744, followed by Random Forest (0.722) and Logistic Regression (0.689). SHAP analysis revealed that 50% of the top 10 predictive features were radiomic parameters (Energy, Max, Median, RMS, and Kurtosis), while key clinical predictors included RENAL score, PADUA score, and Centrality index.
Conclusion: The use of CT-based radiomic features has demonstrated initial potential in predicting recurrence of renal cell carcinoma (RCC) following partial nephrectomy. Combined radiomics-clinical machine learning models demonstrate moderate prognostic accuracy and may be utilized in future multicenter studies involving larger patient cohorts and external validation prior to clinical implementation.
{"title":"Predicting renal-cell carcinoma recurrence after partial nephrectomy: a CT-radiomics approach.","authors":"Stanislav Vovdenko, Igor Kuznetsov, Sabukhi Amrakhov, Mikhail Chernenkiy, Ivan Chernenkiy, Alexandra Proskura, Agabek Zholdubaev, Khalil Ismailov, Andrey Vinogradov, Dmitriy Fiev, Evgeny Sirota, Evgeny Shpot, Yuriy Alyaev, Petr Glybochko","doi":"10.1007/s11255-026-05048-w","DOIUrl":"https://doi.org/10.1007/s11255-026-05048-w","url":null,"abstract":"<p><strong>Background: </strong>About 30-40% of patients with renal-cell carcinoma experience recurrence within 5 years after partial nephrectomy despite current prognostic scoring systems. Radiomic analysis of preoperative CT images has the potential to offer improved risk stratification when compared with conventional clinicopathological variables.</p><p><strong>Objective: </strong>To identify radiomic and clinical prognostic features associated with RCC recurrence after partial nephrectomy and to develop an integrated machine learning model for enhanced recurrence risk stratification.</p><p><strong>Methods: </strong>The retrospective study included 190 RCC patients who underwent laparoscopic partial nephrectomy from 2011 to 2022. Preoperative contrast-enhanced CT scans were analyzed using radiomic feature extraction. Analyzed clinical variables included age, BMI, nephrometry scores (RENAL, PADUA, Centrality index), and tumor volume. Three machine learning algorithms (Random Forest, Gradient Boosting, and Logistic Regression) were trained to predict recurrence, with SHAP analysis for feature importance evaluation.</p><p><strong>Results: </strong>The Gradient Boosting model achieved the highest predictive performance with ROC-AUC of 0.744, followed by Random Forest (0.722) and Logistic Regression (0.689). SHAP analysis revealed that 50% of the top 10 predictive features were radiomic parameters (Energy, Max, Median, RMS, and Kurtosis), while key clinical predictors included RENAL score, PADUA score, and Centrality index.</p><p><strong>Conclusion: </strong>The use of CT-based radiomic features has demonstrated initial potential in predicting recurrence of renal cell carcinoma (RCC) following partial nephrectomy. Combined radiomics-clinical machine learning models demonstrate moderate prognostic accuracy and may be utilized in future multicenter studies involving larger patient cohorts and external validation prior to clinical implementation.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-10DOI: 10.1007/s11255-026-05042-2
Tailong Lv, Wenkai Bao, Shouqiang Chen
Objective: This study aims to analyze the safety profile of sparsentan in real-world clinical settings using data from the FDA Adverse Event Reporting System (FAERS) database, providing insights for its clinical application.
Methods: Data from the FAERS database were collected between the first quarter of 2023 and the fourth quarter of 2024. Adverse events (AEs) associated with sparsentan were identified using the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS). The temporal distribution of AEs was further analyzed using the Weibull distribution to comprehensively assess the safety profile of the drug in clinical practice.
Results: A total of 1776 reports of AEs were retrieved from the FAERS database, with sparsentan identified as the primary suspect (PS) drug. These AEs were reported across 25 system organ classes (SOCs). Forty-four preferred terms (PTs) were retained by the four algorithms, including well-documented adverse reactions listed on the drug label, such as hypotension, hyperkalemia, peripheral edema, and dizziness. In addition, previously unmentioned potential AEs were identified, including nasopharyngitis, ear discomfort, renal pain, and musculoskeletal chest pain. The median time to onset of sparsentan-associated AEs was 18 days (IQR 4-60.5 days), with most events occurring within the first month of treatment.
Conclusion: This study provides real-world data on the clinical application of sparsentan and analyzes the AEs associated with its use. It not only confirms several known adverse effects, but also identifies potential new AEs. These findings offer valuable guidance for clinicians prescribing sparsentan, aiding in the reduction of drug-related risks.
{"title":"Assessing the real-world safety of sparsentan for immunoglobulin A nephropathy: insights from a comprehensive analysis of FAERS database.","authors":"Tailong Lv, Wenkai Bao, Shouqiang Chen","doi":"10.1007/s11255-026-05042-2","DOIUrl":"https://doi.org/10.1007/s11255-026-05042-2","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to analyze the safety profile of sparsentan in real-world clinical settings using data from the FDA Adverse Event Reporting System (FAERS) database, providing insights for its clinical application.</p><p><strong>Methods: </strong>Data from the FAERS database were collected between the first quarter of 2023 and the fourth quarter of 2024. Adverse events (AEs) associated with sparsentan were identified using the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS). The temporal distribution of AEs was further analyzed using the Weibull distribution to comprehensively assess the safety profile of the drug in clinical practice.</p><p><strong>Results: </strong>A total of 1776 reports of AEs were retrieved from the FAERS database, with sparsentan identified as the primary suspect (PS) drug. These AEs were reported across 25 system organ classes (SOCs). Forty-four preferred terms (PTs) were retained by the four algorithms, including well-documented adverse reactions listed on the drug label, such as hypotension, hyperkalemia, peripheral edema, and dizziness. In addition, previously unmentioned potential AEs were identified, including nasopharyngitis, ear discomfort, renal pain, and musculoskeletal chest pain. The median time to onset of sparsentan-associated AEs was 18 days (IQR 4-60.5 days), with most events occurring within the first month of treatment.</p><p><strong>Conclusion: </strong>This study provides real-world data on the clinical application of sparsentan and analyzes the AEs associated with its use. It not only confirms several known adverse effects, but also identifies potential new AEs. These findings offer valuable guidance for clinicians prescribing sparsentan, aiding in the reduction of drug-related risks.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-09DOI: 10.1007/s11255-026-05039-x
Mustafa Guldan, Aladin Rustamov, Rama Al-Shiab, Lasin Ozbek, Alexandru Burlacu, Adrian Covic, Mehmet Kanbay
Blood pressure variability (BPV), fluctuations in blood pressure across beat-to-beat, 24-h, day-to-day, and visit-to-visit timescales, has emerged as a risk marker that is independent of mean blood pressure. Frailty, a multidimensional syndrome of diminished physiological reserve, shares core biology with BPV, including vascular aging, impaired baroreflex function, autonomic dysregulation, and chronic low-grade inflammation. This narrative review synthesizes mechanistic, epidemiologic, and clinical evidence linking BPV and frailty. Mechanistically, arterial stiffness and endothelial dysfunction attenuate baroreflex buffering and transmit excess pulsatile load, while autonomic imbalance and inflammaging destabilize hemodynamics, compromise cerebral autoregulation, and promote sarcopenia and functional decline. Across cohorts of community-dwelling older adults and high-risk groups (e.g., chronic kidney disease and hemodialysis), higher short- and long-term BPV correlates with prevalent frailty and predicts incident frailty, cognitive decline, falls, cardiovascular events, renal progression, and mortality, often with effect sizes on par with traditional risk factors. Ambulatory blood pressure monitoring best captures short-term and circadian variability (including nocturnal patterns), home monitoring informs day-to-day variability, and clinic series quantify visit-to-visit variability; average real variability appears particularly informative in older hypertensive populations. Clinically, incorporating BPV into assessment may refine frailty screening and risk stratification, revealing vulnerability that is not apparent from mean blood pressure alone. Therapeutic implications include prioritizing long-acting antihypertensive regimens that stabilize BPV, optimizing adherence and lifestyle (exercise, diet, stress reduction), and addressing metabolic and inflammatory drivers, while recognizing that interventional evidence targeting BPV per se remains limited. Key gaps include heterogeneous BPV metrics and frailty definitions, limited standardization of measurement protocols, and a paucity of trials testing whether reducing BPV improves functional outcomes. Future work should not only harmonize BPV phenotyping and frailty definitions, but also investigate whether stabilizing BPV translates into tangible improvements in functional status, falls, and survival. Incorporating digital health tools, such as continuous monitoring and AI-driven analytics, may facilitate early detection of hemodynamic instability and its integration into frailty care models.
{"title":"Blood pressure variability and frailty: mechanisms, evidence, and clinical implications.","authors":"Mustafa Guldan, Aladin Rustamov, Rama Al-Shiab, Lasin Ozbek, Alexandru Burlacu, Adrian Covic, Mehmet Kanbay","doi":"10.1007/s11255-026-05039-x","DOIUrl":"10.1007/s11255-026-05039-x","url":null,"abstract":"<p><p>Blood pressure variability (BPV), fluctuations in blood pressure across beat-to-beat, 24-h, day-to-day, and visit-to-visit timescales, has emerged as a risk marker that is independent of mean blood pressure. Frailty, a multidimensional syndrome of diminished physiological reserve, shares core biology with BPV, including vascular aging, impaired baroreflex function, autonomic dysregulation, and chronic low-grade inflammation. This narrative review synthesizes mechanistic, epidemiologic, and clinical evidence linking BPV and frailty. Mechanistically, arterial stiffness and endothelial dysfunction attenuate baroreflex buffering and transmit excess pulsatile load, while autonomic imbalance and inflammaging destabilize hemodynamics, compromise cerebral autoregulation, and promote sarcopenia and functional decline. Across cohorts of community-dwelling older adults and high-risk groups (e.g., chronic kidney disease and hemodialysis), higher short- and long-term BPV correlates with prevalent frailty and predicts incident frailty, cognitive decline, falls, cardiovascular events, renal progression, and mortality, often with effect sizes on par with traditional risk factors. Ambulatory blood pressure monitoring best captures short-term and circadian variability (including nocturnal patterns), home monitoring informs day-to-day variability, and clinic series quantify visit-to-visit variability; average real variability appears particularly informative in older hypertensive populations. Clinically, incorporating BPV into assessment may refine frailty screening and risk stratification, revealing vulnerability that is not apparent from mean blood pressure alone. Therapeutic implications include prioritizing long-acting antihypertensive regimens that stabilize BPV, optimizing adherence and lifestyle (exercise, diet, stress reduction), and addressing metabolic and inflammatory drivers, while recognizing that interventional evidence targeting BPV per se remains limited. Key gaps include heterogeneous BPV metrics and frailty definitions, limited standardization of measurement protocols, and a paucity of trials testing whether reducing BPV improves functional outcomes. Future work should not only harmonize BPV phenotyping and frailty definitions, but also investigate whether stabilizing BPV translates into tangible improvements in functional status, falls, and survival. Incorporating digital health tools, such as continuous monitoring and AI-driven analytics, may facilitate early detection of hemodynamic instability and its integration into frailty care models.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146142371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: To evaluate the feasibility and safety of ileal ureteral replacement (IUR) for long-segment ureteral strictures secondary to urogenital tuberculosis (UGTB).
Method: 11 patients with complex tuberculous ureteral strictures underwent IUR across three tertiary centers between March 2015 and January 2024. Surgical approaches included open (n = 2), laparoscopic (n = 4), and robotic-assisted (n = 5). Demographic characteristics, perioperative data and follow-up outcomes were prospectively collected.
Result: 11 patients (8 males, 3 females) with a mean age of 38.3 ± 13.1 years were included. Two patients had bilateral involvement, and nine patients had unilateral involvement. Four patients underwent concomitant ileocystoplasty. The mean stricture length was 19.0 ± 6.3 cm, and the median length of ileum harvested was 25 cm. The mean operative time was 283.9 ± 28.1 min. The median estimated blood loss was 150 mL. The median postoperative hospital stay was 15 days, with the robotic approach significantly reducing hospitalization time (p = 0.015). During the median follow-up of 36 months, all patients achieved ureteral patency. The mean preoperative and latest estimated glomerular filtration rate were 82.0 ± 24.1 and 74.7 ± 22.9 mL/min/1.73 m2 (p = 0.062), respectively. Complications were reported in 8 patients, primarily metabolic acidosis (6/11) and urinary tract infections (4/11). Metabolic acidosis was associated with renal function decline (p = 0.015). Two patients experienced major complications, consisting of ileus and incision infection respectively.
Conclusion: IUR is a safe and effective last resort for patients with complex ureteral strictures secondary to UGTB. High complication rates and long-term metabolic risks limit its application, necessitating strict patient selection and rigorous lifelong management.
{"title":"Ileal ureteral replacement for tuberculous ureteral strictures: 11 cases of experience.","authors":"Yiming Zhang, Xiang Wang, Zhihua Li, Zihao Tao, Xinfei Li, Peng Zhang, Hongjian Zhu, Hongwei Bai, Kunlin Yang, Liqun Zhou, Kai Zhang, Xuesong Li","doi":"10.1007/s11255-026-05005-7","DOIUrl":"https://doi.org/10.1007/s11255-026-05005-7","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the feasibility and safety of ileal ureteral replacement (IUR) for long-segment ureteral strictures secondary to urogenital tuberculosis (UGTB).</p><p><strong>Method: </strong>11 patients with complex tuberculous ureteral strictures underwent IUR across three tertiary centers between March 2015 and January 2024. Surgical approaches included open (n = 2), laparoscopic (n = 4), and robotic-assisted (n = 5). Demographic characteristics, perioperative data and follow-up outcomes were prospectively collected.</p><p><strong>Result: </strong>11 patients (8 males, 3 females) with a mean age of 38.3 ± 13.1 years were included. Two patients had bilateral involvement, and nine patients had unilateral involvement. Four patients underwent concomitant ileocystoplasty. The mean stricture length was 19.0 ± 6.3 cm, and the median length of ileum harvested was 25 cm. The mean operative time was 283.9 ± 28.1 min. The median estimated blood loss was 150 mL. The median postoperative hospital stay was 15 days, with the robotic approach significantly reducing hospitalization time (p = 0.015). During the median follow-up of 36 months, all patients achieved ureteral patency. The mean preoperative and latest estimated glomerular filtration rate were 82.0 ± 24.1 and 74.7 ± 22.9 mL/min/1.73 m<sup>2</sup> (p = 0.062), respectively. Complications were reported in 8 patients, primarily metabolic acidosis (6/11) and urinary tract infections (4/11). Metabolic acidosis was associated with renal function decline (p = 0.015). Two patients experienced major complications, consisting of ileus and incision infection respectively.</p><p><strong>Conclusion: </strong>IUR is a safe and effective last resort for patients with complex ureteral strictures secondary to UGTB. High complication rates and long-term metabolic risks limit its application, necessitating strict patient selection and rigorous lifelong management.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-06DOI: 10.1007/s11255-026-05031-5
Łukasz Mielczarek, Omar Tayara, Wojciech Malewski, Przemysław Szostek, Paweł Rajwa, Riccardo Bertolo, Fabio Zattoni, Carlo Prevato, Sławomir Poletajew, Łukasz Nyk, Piotr Kryst
Purpose: This study aimed to identify preoperative metabolic and radiological predictors of adherent perinephric fat (APF) and to develop a predictive scoring system for its assessment.
Methods: We conducted a prospective study of consecutive patients with renal tumors undergoing open or minimally invasive partial nephrectomy (PN). APF was intraoperatively defined as the need for subcapsular renal dissection to isolate the tumor. Patient characteristics were compared according to APF presence. Multivariable logistic regression analysis was performed, and the resulting model was used to develop a predictive scoring system.
Results: A total of 200 patients were included in the analysis, of whom 34 (17%) had APF. On multivariable analysis, presence of perinephric fat stranding (p = 0.003), posterior perinephric fat thickness ≥ 25 mm (p < 0.001), serum urea ≥ 33 mg/dl (p = 0.004), albumin ≤ 4.3 g/dl (p = 0.007), and HDL cholesterol ≤ 53 mg/dl (p = 0.019) were predictors of APF. A model incorporating these five variables achieved an area under the receiver operating characteristic curve of 0.92. These parameters were subsequently integrated into the novel SHARP-U (Stranding, HDL cholesterol, Albumin, Renal Perinephric fat thickness, Urea) score, ranging from 0 to 7, to predict the presence of APF.
Conclusion: The SHARP-U score provides a simple and reliable tool for preoperative prediction of APF in patients undergoing partial nephrectomy. Early identification of individuals at risk may aid surgical planning and patient counseling. External prospective validation of the SHARP-U score is warranted to confirm its clinical applicability.
目的:本研究旨在确定附着性肾周围脂肪(APF)的术前代谢和放射学预测因素,并建立预测评分系统进行评估。方法:我们对连续接受开放性或微创部分肾切除术(PN)的肾肿瘤患者进行了前瞻性研究。术中APF被定义为需要囊下肾分离以分离肿瘤。根据APF的存在比较患者的特征。进行多变量logistic回归分析,并利用所得模型开发预测评分系统。结果:共纳入200例患者,其中34例(17%)有APF。在多变量分析中,存在肾周脂肪搁浅(p = 0.003),后肾周脂肪厚度≥25 mm (p)。结论:SHARP-U评分为部分肾切除术患者术前预测APF提供了一种简单可靠的工具。早期识别有风险的个体可能有助于手术计划和患者咨询。需要对SHARP-U评分进行外部前瞻性验证,以确认其临床适用性。
{"title":"Metabolic insights and novel risk score for adherent perinephric fat in partial nephrectomy: results from a prospective study.","authors":"Łukasz Mielczarek, Omar Tayara, Wojciech Malewski, Przemysław Szostek, Paweł Rajwa, Riccardo Bertolo, Fabio Zattoni, Carlo Prevato, Sławomir Poletajew, Łukasz Nyk, Piotr Kryst","doi":"10.1007/s11255-026-05031-5","DOIUrl":"https://doi.org/10.1007/s11255-026-05031-5","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to identify preoperative metabolic and radiological predictors of adherent perinephric fat (APF) and to develop a predictive scoring system for its assessment.</p><p><strong>Methods: </strong>We conducted a prospective study of consecutive patients with renal tumors undergoing open or minimally invasive partial nephrectomy (PN). APF was intraoperatively defined as the need for subcapsular renal dissection to isolate the tumor. Patient characteristics were compared according to APF presence. Multivariable logistic regression analysis was performed, and the resulting model was used to develop a predictive scoring system.</p><p><strong>Results: </strong>A total of 200 patients were included in the analysis, of whom 34 (17%) had APF. On multivariable analysis, presence of perinephric fat stranding (p = 0.003), posterior perinephric fat thickness ≥ 25 mm (p < 0.001), serum urea ≥ 33 mg/dl (p = 0.004), albumin ≤ 4.3 g/dl (p = 0.007), and HDL cholesterol ≤ 53 mg/dl (p = 0.019) were predictors of APF. A model incorporating these five variables achieved an area under the receiver operating characteristic curve of 0.92. These parameters were subsequently integrated into the novel SHARP-U (Stranding, HDL cholesterol, Albumin, Renal Perinephric fat thickness, Urea) score, ranging from 0 to 7, to predict the presence of APF.</p><p><strong>Conclusion: </strong>The SHARP-U score provides a simple and reliable tool for preoperative prediction of APF in patients undergoing partial nephrectomy. Early identification of individuals at risk may aid surgical planning and patient counseling. External prospective validation of the SHARP-U score is warranted to confirm its clinical applicability.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-06DOI: 10.1007/s11255-026-05043-1
Rayyan Nabi, Muhammad Ansab, Amna Hussain, Hamza Bin Ahmed, Najaf Ahmed Rajpar, Sabahat Ul Ain Munir Abbasi, Priyanka Keshav Lal, Owais Ahmad, Hanzala Ahmed Farooqi, Tabeer Zahid, Muhammad Ahmed, Zahid Nabi
Background: Targeted-release budesonide (TRF-budesonide) is a therapy developed to deliver corticosteroid to ileal Peyer's patches and has demonstrated efficacy in randomized trials (NEFIGAN, NefIgArd) for patients with immunoglobulin A nephropathy (IgAN). We performed a systematic review and meta-analysis to evaluate the efficacy and safety of budesonide formulations in IgAN.
Methods: We searched PubMed, Embase, and Cochrane through September 10, 2025. Eligible studies assessed budesonide in biopsy-proven IgAN. Outcomes included change in eGFR, percentage and absolute change in urine protein-to-creatinine ratio (UPCR), and adverse events. Random-effects meta-analyses were performed.
Results: Nine studies (total N = 465; two RCTs) were included. In the comparative analysis of placebo-controlled trials, TRF-budesonide significantly attenuated eGFR decline compared to placebo (weighted mean difference [WMD] 4.53 mL/min/1.73 m2; 95% CI 3.08-5.99). In the single-arm analysis assessing absolute change from baseline, the pooled mean eGFR increase was 3.07 mL/min/1.73m2 (95% CI 0.12-6.03). Regarding proteinuria, TRF-budesonide significantly reduced UPCR compared to placebo (percentage change MD - 28.96%; 95% CI - 45.94 to - 11.99). Safety analysis showed budesonide was associated with a higher risk of adverse events versus placebo (RR 1.18; 95% CI 1.01-1.38). In uncontrolled cohorts, pooled adverse event rates were 40% for TRF-budesonide and 44% for enteric-coated formulations.
Conclusions: Current evidence indicates that TRF-budesonide improves kidney function and reduces proteinuria in adults with IgAN, but conclusions are tempered by limited RCT data, heterogeneity, short follow-up, and sparse histologic end points. Larger, longer randomized trials with standardized outcomes are needed to confirm long-term benefit and safety.
背景:靶向释放布地奈德(trf -布地奈德)是一种用于向回肠Peyer’s贴片输送皮质类固醇的疗法,在随机试验(NEFIGAN, NefIgArd)中证明了对免疫球蛋白a肾病(IgAN)患者的疗效。我们进行了系统回顾和荟萃分析,以评估布地奈德制剂在IgAN中的有效性和安全性。方法:我们检索PubMed, Embase和Cochrane,截止到2025年9月10日。符合条件的研究评估了布地奈德在活检证实的IgAN中的作用。结果包括eGFR的变化、尿蛋白与肌酐比值(UPCR)的百分比和绝对变化以及不良事件。进行随机效应荟萃分析。结果:共纳入9项研究(N = 465; 2项rct)。在安慰剂对照试验的比较分析中,与安慰剂相比,trf -布地奈德显著减轻了eGFR下降(加权平均差[WMD] 4.53 mL/min/1.73 m2; 95% CI 3.08-5.99)。在评估基线绝对变化的单臂分析中,合并平均eGFR增加3.07 mL/min/1.73m2 (95% CI 0.12-6.03)。关于蛋白尿,与安慰剂相比,trf -布地奈德显著降低了UPCR(百分比变化MD - 28.96%; 95% CI - 45.94 - 11.99)。安全性分析显示,与安慰剂相比,布地奈德的不良事件风险更高(RR 1.18; 95% CI 1.01-1.38)。在非对照队列中,trf -布地奈德的总不良事件发生率为40%,肠溶制剂的不良事件发生率为44%。结论:目前的证据表明,trf -布地奈德可以改善成人IgAN患者的肾功能并减少蛋白尿,但由于有限的RCT数据、异质性、短随访和稀疏的组织学终点,结论受到影响。需要规模更大、时间更长、结果标准化的随机试验来确认长期的益处和安全性。
{"title":"Efficacy and safety of budesonide for the treatment of IgA nephropathy: a systematic review and meta-analysis.","authors":"Rayyan Nabi, Muhammad Ansab, Amna Hussain, Hamza Bin Ahmed, Najaf Ahmed Rajpar, Sabahat Ul Ain Munir Abbasi, Priyanka Keshav Lal, Owais Ahmad, Hanzala Ahmed Farooqi, Tabeer Zahid, Muhammad Ahmed, Zahid Nabi","doi":"10.1007/s11255-026-05043-1","DOIUrl":"https://doi.org/10.1007/s11255-026-05043-1","url":null,"abstract":"<p><strong>Background: </strong>Targeted-release budesonide (TRF-budesonide) is a therapy developed to deliver corticosteroid to ileal Peyer's patches and has demonstrated efficacy in randomized trials (NEFIGAN, NefIgArd) for patients with immunoglobulin A nephropathy (IgAN). We performed a systematic review and meta-analysis to evaluate the efficacy and safety of budesonide formulations in IgAN.</p><p><strong>Methods: </strong>We searched PubMed, Embase, and Cochrane through September 10, 2025. Eligible studies assessed budesonide in biopsy-proven IgAN. Outcomes included change in eGFR, percentage and absolute change in urine protein-to-creatinine ratio (UPCR), and adverse events. Random-effects meta-analyses were performed.</p><p><strong>Results: </strong>Nine studies (total N = 465; two RCTs) were included. In the comparative analysis of placebo-controlled trials, TRF-budesonide significantly attenuated eGFR decline compared to placebo (weighted mean difference [WMD] 4.53 mL/min/1.73 m<sup>2</sup>; 95% CI 3.08-5.99). In the single-arm analysis assessing absolute change from baseline, the pooled mean eGFR increase was 3.07 mL/min/1.73m<sup>2</sup> (95% CI 0.12-6.03). Regarding proteinuria, TRF-budesonide significantly reduced UPCR compared to placebo (percentage change MD - 28.96%; 95% CI - 45.94 to - 11.99). Safety analysis showed budesonide was associated with a higher risk of adverse events versus placebo (RR 1.18; 95% CI 1.01-1.38). In uncontrolled cohorts, pooled adverse event rates were 40% for TRF-budesonide and 44% for enteric-coated formulations.</p><p><strong>Conclusions: </strong>Current evidence indicates that TRF-budesonide improves kidney function and reduces proteinuria in adults with IgAN, but conclusions are tempered by limited RCT data, heterogeneity, short follow-up, and sparse histologic end points. Larger, longer randomized trials with standardized outcomes are needed to confirm long-term benefit and safety.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-05DOI: 10.1007/s11255-026-05035-1
Robert Stoica, Jose Medina-Polo, Rustom P Manecksha, Christine Kolb, Melanie Emmeluth, Hans Christian Kuhl, Tarek Hassan, Claus R Riedl
Purpose: The aim of the present study was to evaluate the performance and safety of high molecular weight (HMW) sodium hyaluronate (40 mg/50 mL) for interstitial cystitis/bladder pain syndrome (IC/BPS) in real-world clinical practice.
Methods: This prospective, multicenter European study was conducted in patients with the clinical diagnosis of IC/BPS. Participants received weekly intravesical instillations for 12 weeks. The primary endpoint was responder rate at end of treatment/week 12, defined as any improvement in IC/BPS symptoms on the 7-point Patient Global Assessment (PGA) scale. Secondary endpoints included changes in bladder symptoms and quality of life assessed by visual analog scales (VAS), questionnaires, and voiding diaries at week 12 and 24.
Results: Seventy-one (N = 74) patients enrolled were part of the full analysis set (mean [SD] age: 51.8 [16.9] years; 98.6% female) and 73/74 patients were in the safety set (mean [SD] age: 51.9 [17.2] years; 98.6% female). Total responder rate was 90.1% (90% CI: 82.3, 95.3) at week 12 and 78.9% (90% CI: 69.4, 86.5) at week 24. Significant improvements from baseline were observed in VAS scores for urinary urgency and bladder pain at week 12 (-42.0; -39.3) and week 24 (-49.2; -49.2). Quality of life scores also improved significantly (+ 17.1; + 27.2, all P < .0001). Twenty patients (27.4%) reported 37 adverse events (AEs), including seven treatment-related AEs (incidents). No treatment-related serious AEs occurred and all incidents were resolved.
Conclusions: Intravesical HMW sodium hyaluronate improved IC/BPS symptoms and quality of life through week 24 in most patients with a favorable safety profile.
{"title":"A prospective, multicenter, real-world effectiveness and safety study of high molecular weight sodium hyaluronate for interstitial cystitis/bladder pain syndrome.","authors":"Robert Stoica, Jose Medina-Polo, Rustom P Manecksha, Christine Kolb, Melanie Emmeluth, Hans Christian Kuhl, Tarek Hassan, Claus R Riedl","doi":"10.1007/s11255-026-05035-1","DOIUrl":"https://doi.org/10.1007/s11255-026-05035-1","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of the present study was to evaluate the performance and safety of high molecular weight (HMW) sodium hyaluronate (40 mg/50 mL) for interstitial cystitis/bladder pain syndrome (IC/BPS) in real-world clinical practice.</p><p><strong>Methods: </strong>This prospective, multicenter European study was conducted in patients with the clinical diagnosis of IC/BPS. Participants received weekly intravesical instillations for 12 weeks. The primary endpoint was responder rate at end of treatment/week 12, defined as any improvement in IC/BPS symptoms on the 7-point Patient Global Assessment (PGA) scale. Secondary endpoints included changes in bladder symptoms and quality of life assessed by visual analog scales (VAS), questionnaires, and voiding diaries at week 12 and 24.</p><p><strong>Results: </strong>Seventy-one (N = 74) patients enrolled were part of the full analysis set (mean [SD] age: 51.8 [16.9] years; 98.6% female) and 73/74 patients were in the safety set (mean [SD] age: 51.9 [17.2] years; 98.6% female). Total responder rate was 90.1% (90% CI: 82.3, 95.3) at week 12 and 78.9% (90% CI: 69.4, 86.5) at week 24. Significant improvements from baseline were observed in VAS scores for urinary urgency and bladder pain at week 12 (-42.0; -39.3) and week 24 (-49.2; -49.2). Quality of life scores also improved significantly (+ 17.1; + 27.2, all P < .0001). Twenty patients (27.4%) reported 37 adverse events (AEs), including seven treatment-related AEs (incidents). No treatment-related serious AEs occurred and all incidents were resolved.</p><p><strong>Conclusions: </strong>Intravesical HMW sodium hyaluronate improved IC/BPS symptoms and quality of life through week 24 in most patients with a favorable safety profile.</p>","PeriodicalId":14454,"journal":{"name":"International Urology and Nephrology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146125009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}