Pub Date : 2024-04-17DOI: 10.1177/17562872241244574
Sebastiano Buti, Alessandro Olivari, Cristina Masini, Davide Bimbatti, Donata Sartori, Paola Ermacora, Carlo Cattrini, Maria Giuseppa Vitale, Ernesto Rossi, Claudia Mucciarini, Mimma Rizzo, Michele Sisani, Matteo Santoni, Giandomenico Roviello, Veronica Mollica, Vincenza Conteduca, Francesco Grillone, Marika Cinausero, Giuseppe Prati, Francesco Atzori, Marco Stellato, Francesco Massari, Melissa Bersanelli
Background:The treatment of heavily pretreated patients with metastatic renal cell carcinoma (mRCC) represents an unmet medical need and is still challenging.Objectives:The primary objective was to assess the effectiveness of the lenvatinib plus everolimus combination and the secondary objective was the toxicity profile of this combination.Design:We conducted a longitudinal retrospective study examining mRCC patients pre-treated with one or more lines of therapy among different cancer centers in Italy.Methods:The study included patients who received the combination of lenvatinib plus everolimus as either a second-line treatment or beyond. We assessed progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), response rate (RR), and toxicity profile. In addition, we explored the potential relationship between treatment effectiveness and clinical and laboratory parameters.Results:In all, 33 patients were assessed, the median age was 60 years, 57% had an Eastern Cooperative Oncology Group performance status of 1–2 and. 63% received ⩾ 3 prior lines of therapy. 62% were ‘intermediate risk’ according to the International Metastatic Renal Cell Carcinoma Database Consortium and 30% were ‘poor risk’. The RR was 42% (no complete response), 18% stable disease. Median OS was 11.2 months (95% CI 6.8–19.9), median PFS was 6.7 months (95% CI 0.6–30.8), and median TTF was 6.7 months (95% CI 4.8–16.6). A shorter OS was significantly associated with lymph node metastases ( p = 0.043, 95% CI), neutrophils/ lymphocytes ratio (NLR) ⩾ 3 ( p = 0.007), hemoglobin/red cell distribution width ratio cutoff value <0.7 was significant ( p = 0.03) while a shorter PFS was associated with lung ( p = 0.048) and brain metastases ( p = 0.023). The most frequent G1 toxicity was diarrhea (24%), G2 was fatigue (30%), and hypertension and skin toxicity (6%) for G3.Conclusion:Our findings suggest a clinically relevant effectiveness of lenvatinib plus everolimus combination with an acceptable toxicity profile for heavily pretreated patients with mRCC.
{"title":"Assessing the effectiveness and safety of lenvatinib and everolimus in advanced renal cell carcinoma: insights from the RELIEVE study’s analysis of heavily pretreated patients","authors":"Sebastiano Buti, Alessandro Olivari, Cristina Masini, Davide Bimbatti, Donata Sartori, Paola Ermacora, Carlo Cattrini, Maria Giuseppa Vitale, Ernesto Rossi, Claudia Mucciarini, Mimma Rizzo, Michele Sisani, Matteo Santoni, Giandomenico Roviello, Veronica Mollica, Vincenza Conteduca, Francesco Grillone, Marika Cinausero, Giuseppe Prati, Francesco Atzori, Marco Stellato, Francesco Massari, Melissa Bersanelli","doi":"10.1177/17562872241244574","DOIUrl":"https://doi.org/10.1177/17562872241244574","url":null,"abstract":"Background:The treatment of heavily pretreated patients with metastatic renal cell carcinoma (mRCC) represents an unmet medical need and is still challenging.Objectives:The primary objective was to assess the effectiveness of the lenvatinib plus everolimus combination and the secondary objective was the toxicity profile of this combination.Design:We conducted a longitudinal retrospective study examining mRCC patients pre-treated with one or more lines of therapy among different cancer centers in Italy.Methods:The study included patients who received the combination of lenvatinib plus everolimus as either a second-line treatment or beyond. We assessed progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), response rate (RR), and toxicity profile. In addition, we explored the potential relationship between treatment effectiveness and clinical and laboratory parameters.Results:In all, 33 patients were assessed, the median age was 60 years, 57% had an Eastern Cooperative Oncology Group performance status of 1–2 and. 63% received ⩾ 3 prior lines of therapy. 62% were ‘intermediate risk’ according to the International Metastatic Renal Cell Carcinoma Database Consortium and 30% were ‘poor risk’. The RR was 42% (no complete response), 18% stable disease. Median OS was 11.2 months (95% CI 6.8–19.9), median PFS was 6.7 months (95% CI 0.6–30.8), and median TTF was 6.7 months (95% CI 4.8–16.6). A shorter OS was significantly associated with lymph node metastases ( p = 0.043, 95% CI), neutrophils/ lymphocytes ratio (NLR) ⩾ 3 ( p = 0.007), hemoglobin/red cell distribution width ratio cutoff value <0.7 was significant ( p = 0.03) while a shorter PFS was associated with lung ( p = 0.048) and brain metastases ( p = 0.023). The most frequent G1 toxicity was diarrhea (24%), G2 was fatigue (30%), and hypertension and skin toxicity (6%) for G3.Conclusion:Our findings suggest a clinically relevant effectiveness of lenvatinib plus everolimus combination with an acceptable toxicity profile for heavily pretreated patients with mRCC.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616219","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}
Background:The debate regarding the optimal drainage method for acute obstructive upper urinary tract infection persists, focusing on the choice between percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS).Aims:This study aims to systematically examine the perioperative outcomes and safety associated with PCN and RUS in treating acute obstructive upper urinary tract infections.Methods:A comprehensive investigation was conducted using the Medline, Embase, Web of Science, and Cochrane databases up to December 2022, following the guidelines of the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The utilized keywords included ‘PCN’, ‘RUS’, ‘acute upper obstructive uropathy’, and ‘RCT’. Inclusion criteria encompassed studies providing accurate and analyzable data, which incorporated the total subject count, perioperative outcomes, and complication rates. The assessed perioperative outcomes included fluoroscopy time, normalization of temperature, normalization of serum creatinine, normalization of white blood cell (WBC) count, and operative time. Safety outcomes encompassed failure rate, intraoperative and postoperative hematuria, postoperative fever, postoperative pain, and postoperative nephrostomy tube or stent slippage rate. The study protocol was prospectively registered at PROSPERO (CRD42022352474).Results:The meta-analysis encompassed 7 trials involving 727 patients, with 412 assigned to the PCN group and 315 to the RUS group. The outcome of the meta-analysis unveiled a reduced occurrence of postoperative hematuria in the PCN group [odds ratio (OR) = 0.54, 95% confidence interval (CI) 0.30–0.99, p = 0.04], along with a decreased frequency of insertion failure (OR = 0.42, 95% CI 0.21–0.81, p = 0.01). In addition, the RUS group exhibited a shorter fluoroscopy time than the PCN group (mean difference = 0.31, 95% CI 0.14–0.48, p = 0.0004).Conclusion:Given the significant impact of hematuria and catheterization failure on postoperative quality of life, the preference for PCN appears more advantageous than RUS.
背景：关于急性梗阻性上尿路感染的最佳引流方法的争论一直存在，主要集中在经皮肾造瘘术（PCN）和逆行输尿管支架置入术（RUS）之间的选择上。方法：根据《系统综述和元分析首选报告项目》（Preferred Reporting Items for Systematic Review and Meta-analysis，PRISMA）声明的指导原则，利用 Medline、Embase、Web of Science 和 Cochrane 数据库（截至 2022 年 12 月）进行了全面调查。使用的关键词包括 "PCN"、"RUS"、"急性上梗阻性尿路病变 "和 "RCT"。纳入标准包括提供准确和可分析数据的研究，其中包括受试者总数、围手术期结果和并发症发生率。评估的围手术期结果包括透视时间、体温正常化、血清肌酐正常化、白细胞（WBC）计数正常化和手术时间。安全性结果包括失败率、术中和术后血尿、术后发热、术后疼痛以及术后肾造瘘管或支架滑脱率。研究方案在PROSPERO（CRD42022352474）上进行了前瞻性注册。结果：荟萃分析包括7项试验，涉及727名患者，其中412人被分配到PCN组，315人被分配到RUS组。荟萃分析结果显示，PCN 组术后血尿发生率降低[几率比（OR）= 0.54，95% 置信区间（CI）0.30-0.99，P = 0.04]，插入失败频率降低（OR = 0.42，95% CI 0.21-0.81，P = 0.01）。此外，RUS 组的透视时间比 PCN 组更短（平均差异 = 0.31，95% CI 0.14-0.48，p = 0.0004）。
{"title":"Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection","authors":"Xidong Wang, Gang Wu, Tianqi Wang, Shangjing Liu, Guixin Ding, Qiancheng Mao, Yongli Chu, Yuanshan Cui, Jitao Wu","doi":"10.1177/17562872241241854","DOIUrl":"https://doi.org/10.1177/17562872241241854","url":null,"abstract":"Background:The debate regarding the optimal drainage method for acute obstructive upper urinary tract infection persists, focusing on the choice between percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS).Aims:This study aims to systematically examine the perioperative outcomes and safety associated with PCN and RUS in treating acute obstructive upper urinary tract infections.Methods:A comprehensive investigation was conducted using the Medline, Embase, Web of Science, and Cochrane databases up to December 2022, following the guidelines of the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The utilized keywords included ‘PCN’, ‘RUS’, ‘acute upper obstructive uropathy’, and ‘RCT’. Inclusion criteria encompassed studies providing accurate and analyzable data, which incorporated the total subject count, perioperative outcomes, and complication rates. The assessed perioperative outcomes included fluoroscopy time, normalization of temperature, normalization of serum creatinine, normalization of white blood cell (WBC) count, and operative time. Safety outcomes encompassed failure rate, intraoperative and postoperative hematuria, postoperative fever, postoperative pain, and postoperative nephrostomy tube or stent slippage rate. The study protocol was prospectively registered at PROSPERO (CRD42022352474).Results:The meta-analysis encompassed 7 trials involving 727 patients, with 412 assigned to the PCN group and 315 to the RUS group. The outcome of the meta-analysis unveiled a reduced occurrence of postoperative hematuria in the PCN group [odds ratio (OR) = 0.54, 95% confidence interval (CI) 0.30–0.99, p = 0.04], along with a decreased frequency of insertion failure (OR = 0.42, 95% CI 0.21–0.81, p = 0.01). In addition, the RUS group exhibited a shorter fluoroscopy time than the PCN group (mean difference = 0.31, 95% CI 0.14–0.48, p = 0.0004).Conclusion:Given the significant impact of hematuria and catheterization failure on postoperative quality of life, the preference for PCN appears more advantageous than RUS.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140572265","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 : 2024-04-11DOI: 10.1177/17562872241241864
James S. Bernstein, Om P. Dhingra
Background:Oral testosterone undecanoate (TU) formulations may provide effective, safe, and easily titratable testosterone replacement therapy.Objective:Demonstrate efficacy and safety of a novel oral TU formulation.Design:An open-label, single-arm, multi-center trial treated 155 hypogonadal men for 180 days. Treatment began at 200 mg TU twice daily with meals; doses were titrated over two 28-day cycles to between 100 and 800 mg TU daily, measuring average testosterone (T Cavg) after 90 days. Ambulatory blood pressure monitoring (ABPM) occurred at baseline, 120, and 180 days.Methods:Titrations used a randomized blood sample taken 3-, 4-, or 5-h post-morning dose. Outcomes used sodium fluoride/ethylenediaminetetraacetate plasma testosterone (T) values; serum results were also reported. Blood pressure (ABPM and in-clinic) was evaluated for change from baseline.Results:After titration, 87.8% of KYZATREX™ treated participants (worse-case scenario) and 96.1% of 90-day completers achieved eugonadal mean plasma T values. Serum T Cavg was 452 ng/dL and maximum T concentrations (T Cmax) met all FDA criteria. Participant eugonadal percentages were comparable across subgroups for age, weight, and body mass index. Diet had no effect on participant eugonadal percentages. KYZATREX was well tolerated, with no drug-related serious adverse events (SAE) and one adverse drug reaction (hypertension) observed in 2% or more of participants. Systolic ambulatory blood pressure increased 1.7 mmHg (95% confidence interval: 0.3–3.1). At baseline, 36% of 155 participants were receiving anti-hypertensive medication and 22% were diabetic. No dose increases occurred in existing anti-hypertensive medication; five participants (3.2%) started anti-hypertensive medication.Conclusion:KYZATREX provided safe and effective testosterone levels within the normal range in hypogonadal male study participants.Clinical trial registration:URL: https://clinicaltrials.gov/ unique identifier NCT04467697, conducted under NCT03198728. Post-completion, clinicaltrials.gov requested creation of the separate NCT04467697 identifier. All subjects were recruited under NCT03198728.
{"title":"A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product","authors":"James S. Bernstein, Om P. Dhingra","doi":"10.1177/17562872241241864","DOIUrl":"https://doi.org/10.1177/17562872241241864","url":null,"abstract":"Background:Oral testosterone undecanoate (TU) formulations may provide effective, safe, and easily titratable testosterone replacement therapy.Objective:Demonstrate efficacy and safety of a novel oral TU formulation.Design:An open-label, single-arm, multi-center trial treated 155 hypogonadal men for 180 days. Treatment began at 200 mg TU twice daily with meals; doses were titrated over two 28-day cycles to between 100 and 800 mg TU daily, measuring average testosterone (T C<jats:sub>avg</jats:sub>) after 90 days. Ambulatory blood pressure monitoring (ABPM) occurred at baseline, 120, and 180 days.Methods:Titrations used a randomized blood sample taken 3-, 4-, or 5-h post-morning dose. Outcomes used sodium fluoride/ethylenediaminetetraacetate plasma testosterone (T) values; serum results were also reported. Blood pressure (ABPM and in-clinic) was evaluated for change from baseline.Results:After titration, 87.8% of KYZATREX™ treated participants (worse-case scenario) and 96.1% of 90-day completers achieved eugonadal mean plasma T values. Serum T C<jats:sub>avg</jats:sub> was 452 ng/dL and maximum T concentrations (T C<jats:sub>max</jats:sub>) met all FDA criteria. Participant eugonadal percentages were comparable across subgroups for age, weight, and body mass index. Diet had no effect on participant eugonadal percentages. KYZATREX was well tolerated, with no drug-related serious adverse events (SAE) and one adverse drug reaction (hypertension) observed in 2% or more of participants. Systolic ambulatory blood pressure increased 1.7 mmHg (95% confidence interval: 0.3–3.1). At baseline, 36% of 155 participants were receiving anti-hypertensive medication and 22% were diabetic. No dose increases occurred in existing anti-hypertensive medication; five participants (3.2%) started anti-hypertensive medication.Conclusion:KYZATREX provided safe and effective testosterone levels within the normal range in hypogonadal male study participants.Clinical trial registration:URL: https://clinicaltrials.gov/ unique identifier NCT04467697, conducted under NCT03198728. Post-completion, clinicaltrials.gov requested creation of the separate NCT04467697 identifier. All subjects were recruited under NCT03198728.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140602980","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 : 2024-04-05DOI: 10.1177/17562872241241848
Naveen Wijekoon, Aniruddh Deshpande
Paediatric functional bladder disorders especially those causing daytime symptoms are a common cause of significant psychosocial and/or physical morbidity and impaired quality of life. Despite the availability of many therapeutic modalities, a significant number of children appear to be refractory to treatment and continue to have symptoms. In this review, we aim to evaluate the current evidence in the use of existing and novel therapeutic options for the management of daytime lower urinary tract disorders in children. We also aim to highlight the controversies around the terminology and diagnosis of paediatric lower urinary tract dysfunction (LUTD) and specific conditions. The article will then provide a reasonable critique of the existing and emerging treatment modalities in functional daytime LUTD in children including their mode of action, efficacy, indications, and recent advances. These include standard urotherapy, specific urotherapy comprised of biofeedback, alarm therapy and electrical neural stimulation and pharmacotherapy involving selective and non-selective anticholinergics, ß3 adrenergic agonists, alpha blockers and botulinum toxin. A better understanding of this common clinical problem may help clinicians achieve better profiling of these children’s diagnoses to further enable specific, targeted treatment.
{"title":"Treatment modalities for paediatric functional daytime lower urinary tract disorders: an updated review","authors":"Naveen Wijekoon, Aniruddh Deshpande","doi":"10.1177/17562872241241848","DOIUrl":"https://doi.org/10.1177/17562872241241848","url":null,"abstract":"Paediatric functional bladder disorders especially those causing daytime symptoms are a common cause of significant psychosocial and/or physical morbidity and impaired quality of life. Despite the availability of many therapeutic modalities, a significant number of children appear to be refractory to treatment and continue to have symptoms. In this review, we aim to evaluate the current evidence in the use of existing and novel therapeutic options for the management of daytime lower urinary tract disorders in children. We also aim to highlight the controversies around the terminology and diagnosis of paediatric lower urinary tract dysfunction (LUTD) and specific conditions. The article will then provide a reasonable critique of the existing and emerging treatment modalities in functional daytime LUTD in children including their mode of action, efficacy, indications, and recent advances. These include standard urotherapy, specific urotherapy comprised of biofeedback, alarm therapy and electrical neural stimulation and pharmacotherapy involving selective and non-selective anticholinergics, ß<jats:sub>3</jats:sub> adrenergic agonists, alpha blockers and botulinum toxin. A better understanding of this common clinical problem may help clinicians achieve better profiling of these children’s diagnoses to further enable specific, targeted treatment.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140592194","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 : 2024-04-02DOI: 10.1177/17562872241241858
Alexandra R. Siegal, Kenan E. Celtik, Shirin Razdan, Michaela Sljivich, Bryan Kansas, Bhavik Shah, Laurence A. Levine, Robert J. Valenzuela
Background:The increasing popularity of the silicone sleeve penile implant has been accompanied by concerns over potential risks and adverse events.Objectives:To provide multi-institutional data on safety outcomes in patients undergoing silicone sleeve penile implant surgery across high-volume implant surgeons. In addition, we discuss preventative techniques to minimize postoperative complications and the management of these events.Design and methods:We performed a retrospective analysis of men undergoing penile silicone sleeve implants between November 2020 and November 2022 with four surgeons, each from a separate institution. Perioperative and postoperative adverse events, including unsatisfactory cosmetic outcomes requiring revision, were determined by physician follow-up. Flaccid penile length and girth were measured preoperatively and postoperatively.Results:A total of 299 male patients underwent silicone sleeve implant surgery, with an average age of 42.5 ± 10.5 years and an average body mass index of 28.5 ± 4.0. The patient cohort exhibited minimal comorbidities, with 5% having hyperlipidemia, 2% being smokers, 2% having cardiovascular disease, and 1% having diabetes. Patients experienced an average increase of 4.1 ± 1.5 cm in their flaccid penile length (a 50% increase) and an average increase of 3.4 ± 1.5 cm in their flaccid girth (a 37% increase) ( p < 0.01). Complication rates included new-onset postoperative erectile dysfunction (0%), infection (1.3%), seroma (2.0%), and erosion (5.0%). The average follow-up time was 11.6 months. Notably, our rates of infection and seroma were lower than those reported in a previous single-center review, while erosion rates were higher.Conclusion:This is the largest study to characterize the safety of the penile silicone sleeve implant across multiple institutions. In men who desire cosmetic size augmentation, silicone sleeve implant surgery is associated with significantly increased flaccid penile length and girth. Complications are mainly cosmetic and may be corrected; however, patients should be appropriately counseled on the risk of erosion, which appears to be higher than previously reported.
{"title":"A multi-institutional update on surgical outcomes after penile silicone sleeve implantation","authors":"Alexandra R. Siegal, Kenan E. Celtik, Shirin Razdan, Michaela Sljivich, Bryan Kansas, Bhavik Shah, Laurence A. Levine, Robert J. Valenzuela","doi":"10.1177/17562872241241858","DOIUrl":"https://doi.org/10.1177/17562872241241858","url":null,"abstract":"Background:The increasing popularity of the silicone sleeve penile implant has been accompanied by concerns over potential risks and adverse events.Objectives:To provide multi-institutional data on safety outcomes in patients undergoing silicone sleeve penile implant surgery across high-volume implant surgeons. In addition, we discuss preventative techniques to minimize postoperative complications and the management of these events.Design and methods:We performed a retrospective analysis of men undergoing penile silicone sleeve implants between November 2020 and November 2022 with four surgeons, each from a separate institution. Perioperative and postoperative adverse events, including unsatisfactory cosmetic outcomes requiring revision, were determined by physician follow-up. Flaccid penile length and girth were measured preoperatively and postoperatively.Results:A total of 299 male patients underwent silicone sleeve implant surgery, with an average age of 42.5 ± 10.5 years and an average body mass index of 28.5 ± 4.0. The patient cohort exhibited minimal comorbidities, with 5% having hyperlipidemia, 2% being smokers, 2% having cardiovascular disease, and 1% having diabetes. Patients experienced an average increase of 4.1 ± 1.5 cm in their flaccid penile length (a 50% increase) and an average increase of 3.4 ± 1.5 cm in their flaccid girth (a 37% increase) ( p < 0.01). Complication rates included new-onset postoperative erectile dysfunction (0%), infection (1.3%), seroma (2.0%), and erosion (5.0%). The average follow-up time was 11.6 months. Notably, our rates of infection and seroma were lower than those reported in a previous single-center review, while erosion rates were higher.Conclusion:This is the largest study to characterize the safety of the penile silicone sleeve implant across multiple institutions. In men who desire cosmetic size augmentation, silicone sleeve implant surgery is associated with significantly increased flaccid penile length and girth. Complications are mainly cosmetic and may be corrected; however, patients should be appropriately counseled on the risk of erosion, which appears to be higher than previously reported.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140592561","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 : 2024-03-08DOI: 10.1177/17562872241232582
Shenthiuiyan Theivendrampillai, Bob Yang, Mark Little, Christopher Blick
Background:Transperineal biopsy of magnetic resonance imaging (MRI)-detected prostate lesions is now the established technique used in prostate cancer (CaP) diagnostics. Virtual Surgery Intelligence (VSI) Holomedicine by Apoqlar (Hamburg, Germany) is a mixed reality (MR)/augmented reality (AR) software platform that runs on the HoloLens II system (Microsoft, Redford, USA). Multiparametric prostate MRI images were converted into 3D holograms and added into a MR space, enabling visualization of a 3D hologram and image-assisted prostate biopsy.Objective:The Targeted Augmented Reality-GuidEd Transperineal (TARGET) study investigated the feasibility of performing AR-guided prostate biopsies in a MR framework, using the VSI platform in patients with MRI-detected prostate lesions.Methods:Ten patients with a clinical suspicion of CaP on MRI (Prostate Imaging-Reporting and Data System, PI-RADS 4/5) were uploaded to the VSI HoloLens system. Two MR/AR-guided prostate biopsies were then acquired using the PrecisionPoint Freehand transperineal biopsy system. Cognitive fusion biopsies were performed as standard of care following the MR/AR-guided prostate biopsies.Results:All 10 patients successfully underwent MR/AR-guided prostate biopsy after 3D MR images were overlaid on the patient’s body. Prostatic tissue was obtained in all MR/AR-guided specimens. Seven patients (70%) had matching histology in both the standard and MR/AR-guided biopsies. The remaining three had ISUP (International Society of Urological Pathology) Grade 2 CaP. There were no immediate complications.Conclusion:We believe this is a world first. The initial feasibility data from the TARGET study demonstrated that an MR/AR-guided prostate biopsy utilizing the VSI Holomedicine system is a viable option in CaP diagnostics. The next stage in development is to combine AR images with real-time needle insertion and to provide further data to formally appraise the sensitivity and specificity of the technique.
{"title":"Targeted augmented reality-guided transperineal prostate biopsies study: initial experience","authors":"Shenthiuiyan Theivendrampillai, Bob Yang, Mark Little, Christopher Blick","doi":"10.1177/17562872241232582","DOIUrl":"https://doi.org/10.1177/17562872241232582","url":null,"abstract":"Background:Transperineal biopsy of magnetic resonance imaging (MRI)-detected prostate lesions is now the established technique used in prostate cancer (CaP) diagnostics. Virtual Surgery Intelligence (VSI) Holomedicine by Apoqlar (Hamburg, Germany) is a mixed reality (MR)/augmented reality (AR) software platform that runs on the HoloLens II system (Microsoft, Redford, USA). Multiparametric prostate MRI images were converted into 3D holograms and added into a MR space, enabling visualization of a 3D hologram and image-assisted prostate biopsy.Objective:The Targeted Augmented Reality-GuidEd Transperineal (TARGET) study investigated the feasibility of performing AR-guided prostate biopsies in a MR framework, using the VSI platform in patients with MRI-detected prostate lesions.Methods:Ten patients with a clinical suspicion of CaP on MRI (Prostate Imaging-Reporting and Data System, PI-RADS 4/5) were uploaded to the VSI HoloLens system. Two MR/AR-guided prostate biopsies were then acquired using the PrecisionPoint Freehand transperineal biopsy system. Cognitive fusion biopsies were performed as standard of care following the MR/AR-guided prostate biopsies.Results:All 10 patients successfully underwent MR/AR-guided prostate biopsy after 3D MR images were overlaid on the patient’s body. Prostatic tissue was obtained in all MR/AR-guided specimens. Seven patients (70%) had matching histology in both the standard and MR/AR-guided biopsies. The remaining three had ISUP (International Society of Urological Pathology) Grade 2 CaP. There were no immediate complications.Conclusion:We believe this is a world first. The initial feasibility data from the TARGET study demonstrated that an MR/AR-guided prostate biopsy utilizing the VSI Holomedicine system is a viable option in CaP diagnostics. The next stage in development is to combine AR images with real-time needle insertion and to provide further data to formally appraise the sensitivity and specificity of the technique.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140071851","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}
Renal cell carcinoma (RCC) is the most common type of kidney cancer and is divided into two distinct subtypes, clear cell renal cell carcinoma (ccRCC) and non-clear cell renal cell carcinoma (nccRCC). Although many treatments exist for RCC, these are largely based on clinical trials performed in ccRCC and there are limited studies on the management of nccRCC. Non-clear cell RCC consists of multiple histological subtypes: papillary, chromophobe, translocation, medullary, collecting duct, unclassified, and other rare histologies. Due to variations in pathogenesis and therapeutic response, therapy should be tailored to specific variant histologies. For patients with localized nccRCC, surgical resection remains the gold standard. In the metastatic setting, the standard of care has yet to be clearly defined, and most guidelines recommend clinical trial participation. General therapeutic options include immunotherapy, either as monotherapy or in combination, targeted therapies such as vascular endothelial growth factor tyrosine kinase inhibitors and MET inhibitors, and chemotherapy in certain subtypes. Here we present a review of the incidence and pathogenesis of the various subtypes, as well as available clinical data to support therapeutic recommendations for these subtypes. We also highlight currently available clinical trials in nccRCC and future directions in investigating novel treatment modalities tailored to patients with variant histology.
{"title":"The incidence, pathogenesis, and management of non-clear cell renal cell carcinoma","authors":"Priyanka Naik, Harshitha Dudipala, Yu-Wei Chen, Brent Rose, Aditya Bagrodia, Rana R. McKay","doi":"10.1177/17562872241232578","DOIUrl":"https://doi.org/10.1177/17562872241232578","url":null,"abstract":"Renal cell carcinoma (RCC) is the most common type of kidney cancer and is divided into two distinct subtypes, clear cell renal cell carcinoma (ccRCC) and non-clear cell renal cell carcinoma (nccRCC). Although many treatments exist for RCC, these are largely based on clinical trials performed in ccRCC and there are limited studies on the management of nccRCC. Non-clear cell RCC consists of multiple histological subtypes: papillary, chromophobe, translocation, medullary, collecting duct, unclassified, and other rare histologies. Due to variations in pathogenesis and therapeutic response, therapy should be tailored to specific variant histologies. For patients with localized nccRCC, surgical resection remains the gold standard. In the metastatic setting, the standard of care has yet to be clearly defined, and most guidelines recommend clinical trial participation. General therapeutic options include immunotherapy, either as monotherapy or in combination, targeted therapies such as vascular endothelial growth factor tyrosine kinase inhibitors and MET inhibitors, and chemotherapy in certain subtypes. Here we present a review of the incidence and pathogenesis of the various subtypes, as well as available clinical data to support therapeutic recommendations for these subtypes. We also highlight currently available clinical trials in nccRCC and future directions in investigating novel treatment modalities tailored to patients with variant histology.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140006850","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 : 2024-02-28eCollection Date: 2024-01-01DOI: 10.1177/17562872241229876
Elodie Coquan, Nicolas Penel, Justine Lequesne, Raphaël Leman, Pernelle Lavaud, Zoé Neviere, Pierre-Emmanuel Brachet, Emeline Meriaux, Aurélien Carnot, Jérémy Boutrois, Marie Castera, Nicolas Goardon, Etienne Muller, Alexandra Leconte, Antoine Thiery-Vuillemin, Bénédicte Clarisse, Florence Joly
Introduction: DNA damage repair genes are altered in 20-35% of metastatic castration-resistant prostate cancer (mCRPC). Poly-ADP (Adénosine Diphosphate)-ribose polymerase inhibitors (PARPi) showed significant activity for these selected tumors, especially with homologous recombination repair (HRR) deficiency. These alterations could also predict platinum sensitivity. Although carboplatin was inconclusive in unselected mCRPC, the literature suggests an anti-tumoral activity in mCRPC with HHR gene alterations. We aimed to assess the efficacy of carboplatin monotherapy in mCRPC patients with HRR deficiency.
Methods: This prospective multicenter single-arm two-stage phase II addressed mCRPC men with HRR somatic and/or germline alterations, pretreated with ⩾2 taxane chemotherapy regimens and one androgen receptor pathway inhibitor. Prior PARPi treatment was allowed. Enrolled patients received intravenous carboplatin (AUC5) every 21 days for 6-9 cycles. The primary endpoint was the best response rate according to adapted PCWG3 guidelines: radiological response (RECIST 1.1 criteria) and/or biological response [⩾50% prostate-specific antigen (PSA) decline].
Results: A total of 15 out of 16 enrolled patients started carboplatin treatment. Genomic alterations were identified for BRCA2 (n = 5), CDK12 (n = 3), ATM (n = 3) CHEK2 (n = 2), CHEK1 (n = 1), and BRCA1 (n = 1) genes. Objective response (partial biological response + stable radiological response) was achieved in one patient (6.7%), carrying a BRCA2 mutation and not pre-treated with PARPi; stable disease was observed for five patients (33.5%). Among seven patients (46.7%) with previous PARPi treatment, four patients (57.1%) had a stable disease. The median progression-free and overall survivals were 1.9 [95% confidence interval (95% CI), 1.8-9.5] and 8.6 months (95% CI, 4.3-19.5), respectively. The most common severe (grade 3-4) treatment-related toxicities were thrombocytopenia (66.7%), anemia (66.7%), and nausea (60%). Overall, 8 (53.3%) patients experienced a severe hematological event.
Conclusion: The study was prematurely stopped as pre-planned considering the limited activity of carboplatin monotherapy in heavily pre-treated, HHR-deficient mCRPC patients. Larger experience is needed in mCRPC with BRCA alterations.
Trial registration: NCT03652493, EudraCT ID number 2017-004764-35.
{"title":"Carboplatin in metastatic castration-resistant prostate cancer patients with molecular alterations of the DNA damage repair pathway: the PRO-CARBO phase II trial.","authors":"Elodie Coquan, Nicolas Penel, Justine Lequesne, Raphaël Leman, Pernelle Lavaud, Zoé Neviere, Pierre-Emmanuel Brachet, Emeline Meriaux, Aurélien Carnot, Jérémy Boutrois, Marie Castera, Nicolas Goardon, Etienne Muller, Alexandra Leconte, Antoine Thiery-Vuillemin, Bénédicte Clarisse, Florence Joly","doi":"10.1177/17562872241229876","DOIUrl":"10.1177/17562872241229876","url":null,"abstract":"<p><strong>Introduction: </strong>DNA damage repair genes are altered in 20-35% of metastatic castration-resistant prostate cancer (mCRPC). Poly-ADP (Adénosine Diphosphate)-ribose polymerase inhibitors (PARPi) showed significant activity for these selected tumors, especially with homologous recombination repair (HRR) deficiency. These alterations could also predict platinum sensitivity. Although carboplatin was inconclusive in unselected mCRPC, the literature suggests an anti-tumoral activity in mCRPC with HHR gene alterations. We aimed to assess the efficacy of carboplatin monotherapy in mCRPC patients with HRR deficiency.</p><p><strong>Methods: </strong>This prospective multicenter single-arm two-stage phase II addressed mCRPC men with HRR somatic and/or germline alterations, pretreated with ⩾2 taxane chemotherapy regimens and one androgen receptor pathway inhibitor. Prior PARPi treatment was allowed. Enrolled patients received intravenous carboplatin (AUC5) every 21 days for 6-9 cycles. The primary endpoint was the best response rate according to adapted PCWG3 guidelines: radiological response (RECIST 1.1 criteria) and/or biological response [⩾50% prostate-specific antigen (PSA) decline].</p><p><strong>Results: </strong>A total of 15 out of 16 enrolled patients started carboplatin treatment. Genomic alterations were identified for <i>BRCA2</i> (<i>n</i> = 5), <i>CDK12</i> (<i>n</i> = 3), <i>ATM</i> (<i>n</i> = 3) <i>CHEK2</i> (<i>n</i> = 2), <i>CHEK1</i> (<i>n</i> = 1), and <i>BRCA1</i> (<i>n</i> = 1) genes. Objective response (partial biological response + stable radiological response) was achieved in one patient (6.7%), carrying a BRCA2 mutation and not pre-treated with PARPi; stable disease was observed for five patients (33.5%). Among seven patients (46.7%) with previous PARPi treatment, four patients (57.1%) had a stable disease. The median progression-free and overall survivals were 1.9 [95% confidence interval (95% CI), 1.8-9.5] and 8.6 months (95% CI, 4.3-19.5), respectively. The most common severe (grade 3-4) treatment-related toxicities were thrombocytopenia (66.7%), anemia (66.7%), and nausea (60%). Overall, 8 (53.3%) patients experienced a severe hematological event.</p><p><strong>Conclusion: </strong>The study was prematurely stopped as pre-planned considering the limited activity of carboplatin monotherapy in heavily pre-treated, HHR-deficient mCRPC patients. Larger experience is needed in mCRPC with BRCA alterations.</p><p><strong>Trial registration: </strong>NCT03652493, EudraCT ID number 2017-004764-35.</p>","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10903225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139997452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-22DOI: 10.1177/17562872241232275
Victoria Jahrreiss, Carlotta Nedbal, Daniele Castellani, Vineet Gauhar, Christian Seitz, Guohua Zeng, Patrick Juliebø-Jones, Etienne Keller, Lazaros Tzelves, Rob Geraghty, Karan Rangarajan, Olivier Traxer, Joe Philip, Andreas Skolarikos, Panagiotis Kallidonis, Ewa Bres-Niewada, Bhaskar Somani
{"title":"Is suction the future of endourology? Overview from EAU Section of Urolithiasis","authors":"Victoria Jahrreiss, Carlotta Nedbal, Daniele Castellani, Vineet Gauhar, Christian Seitz, Guohua Zeng, Patrick Juliebø-Jones, Etienne Keller, Lazaros Tzelves, Rob Geraghty, Karan Rangarajan, Olivier Traxer, Joe Philip, Andreas Skolarikos, Panagiotis Kallidonis, Ewa Bres-Niewada, Bhaskar Somani","doi":"10.1177/17562872241232275","DOIUrl":"https://doi.org/10.1177/17562872241232275","url":null,"abstract":"","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139954754","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 : 2024-02-22DOI: 10.1177/17562872241232581
Deama AlGhamdi, Samera F. AlBasri
Cervical cerclage is a common procedure employed to prevent preterm birth in women with cervical insufficiency. Complications such as injuries to the cervix and bladder, and premature membrane rupture are well-documented, while genitourinary fistulas are a rare occurrence. This article reports a rare case of vesicovaginal fistula (VVF) formation in a 27-year-old woman following the placement of a McDonald cervical cerclage. The patient presented with continuous watery vaginal leakage, which began during the last 2 months of her pregnancy. Clinical and cystoscopic examinations revealed the presence of a VVF, which was further confirmed through voiding cystourethrography and perineal magnetic resonance imaging. Notably, the patient had undergone the cerclage procedure 18 months prior to the onset of symptoms, making this case particularly unusual. We believe that the VVF formation was associated with the use of Mersilene tape, which may have slowly eroded through the cervix and subsequently breached the urothelium. This case underscores the importance of considering cerclage-related genitourinary fistulas as potential complications, especially when evaluating and counseling patients who have undergone cervical procedures like the McDonald technique. In conclusion, this case highlights the need for vigilant monitoring and a high index of suspicion in patients presenting with symptoms of genitourinary fistulas after such procedures. Further research and awareness in this area are warranted to better understand the risk factors and mechanisms underlying this unusual complication.
{"title":"Formation of vesicovaginal fistula after modified McDonald cerclage placement: a case report with literature review","authors":"Deama AlGhamdi, Samera F. AlBasri","doi":"10.1177/17562872241232581","DOIUrl":"https://doi.org/10.1177/17562872241232581","url":null,"abstract":"Cervical cerclage is a common procedure employed to prevent preterm birth in women with cervical insufficiency. Complications such as injuries to the cervix and bladder, and premature membrane rupture are well-documented, while genitourinary fistulas are a rare occurrence. This article reports a rare case of vesicovaginal fistula (VVF) formation in a 27-year-old woman following the placement of a McDonald cervical cerclage. The patient presented with continuous watery vaginal leakage, which began during the last 2 months of her pregnancy. Clinical and cystoscopic examinations revealed the presence of a VVF, which was further confirmed through voiding cystourethrography and perineal magnetic resonance imaging. Notably, the patient had undergone the cerclage procedure 18 months prior to the onset of symptoms, making this case particularly unusual. We believe that the VVF formation was associated with the use of Mersilene tape, which may have slowly eroded through the cervix and subsequently breached the urothelium. This case underscores the importance of considering cerclage-related genitourinary fistulas as potential complications, especially when evaluating and counseling patients who have undergone cervical procedures like the McDonald technique. In conclusion, this case highlights the need for vigilant monitoring and a high index of suspicion in patients presenting with symptoms of genitourinary fistulas after such procedures. Further research and awareness in this area are warranted to better understand the risk factors and mechanisms underlying this unusual complication.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139954662","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}
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