Chrystal Chang, David Barham, Martin S. Gross, Faysal Yafi, Jay Simhan
{"title":"Response to Huang and Gu","authors":"Chrystal Chang, David Barham, Martin S. Gross, Faysal Yafi, Jay Simhan","doi":"10.1111/bju.70017","DOIUrl":"10.1111/bju.70017","url":null,"abstract":"","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 2","pages":""},"PeriodicalIF":4.4,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145434961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Samuel A. Gold, Amy L. Tin, Viranda H. Jayalath, Fady Baky, Nicole Liso, Brandon Williams, Rebecca Yu, Darren R. Feldman, Samuel A. Funt, Andrew J. Vickers, Joel Sheinfeld, Richard S. Matulewicz
Objective
To evaluate the psychometric properties of the Testicular Health Outcomes Report (THOR) tool by assessing associations of disease burden and treatment received with health-related quality of life (HRQoL) domains.
Materials and Methods
THOR, which comprises 26 questions across 14 HRQoL domains, was administered electronically to patients presenting for known or suspected testicular cancer prior to clinical visits and throughout their care longitudinally. We evaluated construct validity by determining whether related constructs showed better correlation with disease and treatment burden than unrelated constructs. Generalised estimating equations were used for each domain or predictor of interest.
Results
Between August 2022 and November 2024, 709 patients completed 906 surveys. More aggressive post-orchiectomy treatment – such as retroperitoneal lymph node dissection (RPLND), chemotherapy or post-chemotherapy RPLND – was associated with worse sexual function and problems with job/education. Patients undergoing nerve-sparing RPLND reported significantly better sexual function (22 points, 95% confidence interval 11, 33; P < 0.001) as compared to a non-nerve-sparing RPLND approach. Receipt of chemotherapy was associated with lower fertility confidence vs surveillance or primary RPLND (P = 0.005). Psychosocial domain scores and concern about disease relapse improved with time (P < 0.001). However, concern about relapse was not associated with initial clinical stage.
Conclusions
The THOR survey instrument is a valid measure of symptom burden and treatment received in men with testicular cancer.
{"title":"Validation of the Testicular Health Outcomes Report (THOR): a testicular cancer health-related quality of life instrument","authors":"Samuel A. Gold, Amy L. Tin, Viranda H. Jayalath, Fady Baky, Nicole Liso, Brandon Williams, Rebecca Yu, Darren R. Feldman, Samuel A. Funt, Andrew J. Vickers, Joel Sheinfeld, Richard S. Matulewicz","doi":"10.1111/bju.70068","DOIUrl":"10.1111/bju.70068","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To evaluate the psychometric properties of the Testicular Health Outcomes Report (THOR) tool by assessing associations of disease burden and treatment received with health-related quality of life (HRQoL) domains.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>THOR, which comprises 26 questions across 14 HRQoL domains, was administered electronically to patients presenting for known or suspected testicular cancer prior to clinical visits and throughout their care longitudinally. We evaluated construct validity by determining whether related constructs showed better correlation with disease and treatment burden than unrelated constructs. Generalised estimating equations were used for each domain or predictor of interest.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Between August 2022 and November 2024, 709 patients completed 906 surveys. More aggressive post-orchiectomy treatment – such as retroperitoneal lymph node dissection (RPLND), chemotherapy or post-chemotherapy RPLND – was associated with worse sexual function and problems with job/education. Patients undergoing nerve-sparing RPLND reported significantly better sexual function (22 points, 95% confidence interval 11, 33; <i>P</i> < 0.001) as compared to a non-nerve-sparing RPLND approach. Receipt of chemotherapy was associated with lower fertility confidence vs surveillance or primary RPLND (<i>P</i> = 0.005). Psychosocial domain scores and concern about disease relapse improved with time (<i>P</i> < 0.001). However, concern about relapse was not associated with initial clinical stage.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The THOR survey instrument is a valid measure of symptom burden and treatment received in men with testicular cancer.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 2","pages":"289-296"},"PeriodicalIF":4.4,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145440651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ymer Bushati, Allen Ao Guo, Benjamin T. Muston, Aidin Bushati, Niranjan Sathianathen, Jonathan Kam, Jeremy Teoh, Mohamed Khadra, Isaac Thangasamy
Objective
To evaluate the oncological control and functional outcomes of focal laser ablation (FLA) in the management of localised prostate cancer.
Methods
A systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. An electronic search identified studies reporting outcomes of FLA for localised prostate cancer. The primary outcome was oncological control, assessed by recurrence on follow-up biopsy and prostate-specific antigen (PSA) level reduction. Secondary outcomes included adverse events and functional outcomes, specifically sexual and urinary function.
Results
The search identified 12 studies for inclusion, including 421 patients who underwent FLA for localised prostate cancer. The rate of recurrence of clinically significant cancer on biopsy following FLA was 15% (95% confidence interval [CI] 11–20%). The mean reduction in PSA level at 12-months post-FLA was 2.3 ng/mL (95% CI 1.5–3.2 ng/mL). There was a statistically significant (P < 0.001), but not clinically significant (Cohen's d = 0.29) decrease in sexual function, and no statistically significant change in urinary function following FLA. Heterogeneity in patient selection, follow-up protocols, and definitions of recurrence limit cross-study comparisons and generalisability.
Conclusions
The present systematic review and meta-analysis found that FLA provides oncological control comparable to other focal therapies while preserving functional outcomes. However, the limited availability of high-quality comparative studies highlights the need for further robust studies to validate these findings.
目的评价局部激光消融治疗局限性前列腺癌的肿瘤控制和功能预后。方法根据系统评价和荟萃分析指南的首选报告项目进行系统评价和荟萃分析。电子检索确定了报告FLA治疗局限性前列腺癌结果的研究。主要结果是肿瘤控制，通过随访活检的复发和前列腺特异性抗原（PSA）水平降低来评估。次要结局包括不良事件和功能结局，特别是性功能和泌尿功能。结果：纳入了12项研究，包括421例因局部前列腺癌接受FLA治疗的患者。FLA术后有临床意义的活检癌复发率为15%（95%可信区间[CI] 11-20%）。fla后12个月PSA水平平均下降2.3 ng/mL （95% CI 1.5-3.2 ng/mL）。术后性功能下降（P < 0.001），尿功能变化无统计学意义（Cohen’s d = 0.29），但有统计学意义（P < 0.001）。患者选择、随访方案和复发定义的异质性限制了交叉研究的比较和普遍性。本系统综述和荟萃分析发现，与其他局灶性治疗相比，FLA提供了肿瘤控制，同时保留了功能结果。然而，高质量比较研究的有限可用性突出表明需要进一步的可靠研究来验证这些发现。
{"title":"Focal laser ablation in prostate cancer: a systematic review and meta-analysis","authors":"Ymer Bushati, Allen Ao Guo, Benjamin T. Muston, Aidin Bushati, Niranjan Sathianathen, Jonathan Kam, Jeremy Teoh, Mohamed Khadra, Isaac Thangasamy","doi":"10.1111/bju.70064","DOIUrl":"10.1111/bju.70064","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To evaluate the oncological control and functional outcomes of focal laser ablation (FLA) in the management of localised prostate cancer.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. An electronic search identified studies reporting outcomes of FLA for localised prostate cancer. The primary outcome was oncological control, assessed by recurrence on follow-up biopsy and prostate-specific antigen (PSA) level reduction. Secondary outcomes included adverse events and functional outcomes, specifically sexual and urinary function.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The search identified 12 studies for inclusion, including 421 patients who underwent FLA for localised prostate cancer. The rate of recurrence of clinically significant cancer on biopsy following FLA was 15% (95% confidence interval [CI] 11–20%). The mean reduction in PSA level at 12-months post-FLA was 2.3 ng/mL (95% CI 1.5–3.2 ng/mL). There was a statistically significant (<i>P</i> < 0.001), but not clinically significant (Cohen's <i>d</i> = 0.29) decrease in sexual function, and no statistically significant change in urinary function following FLA. Heterogeneity in patient selection, follow-up protocols, and definitions of recurrence limit cross-study comparisons and generalisability.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The present systematic review and meta-analysis found that FLA provides oncological control comparable to other focal therapies while preserving functional outcomes. However, the limited availability of high-quality comparative studies highlights the need for further robust studies to validate these findings.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 2","pages":"251-259"},"PeriodicalIF":4.4,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145440650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marie Buzzi, Jonathan Epstein, Zahi Hatem, Nadine Juge, Charles Mazeaud, Jean-Louis Lemelle, Nicolas Berte
Background
Neurogenic bladder is defined as a dysfunction of the bladder resulting from damage to the central or peripheral nervous systems. Its treatment is based on a progressive therapeutic escalation, rapidly involving invasive therapeutic procedures such as repeated intradetrusor injections and surgery. Given the risk of repeated general anaesthesia in children, there is a need for non-invasive treatment for young patients who do not respond to or have adverse effects from oral anticholinergic treatment. The ‘Place de l’OXybutynine Intravésicale chez le Patient Enfant Neurologique’ (POXIPEN) trial aims to assess the efficacy of intra-vesical oxybutynin on bladder capacity in a sample of French children with neurogenic bladder.
Study Design
The POXIPEN is a multicentre, randomised, double-blind, placebo-controlled trial.
Endpoints
The primary outcome is change in maximal bladder capacity after treatment. Secondary outcomes include changes in voiding, urodynamic and ultrasound parameters. We will also assess changes on quality of life and usability of the product.
Patients and Methods
We aim to randomly assign 60 children with neurogenic bladder secondary to spina bifida and deemed non-responders to first-line treatment with oral anticholinergics, to receive intravesical oxybutynin (IVO) or placebo for 4 weeks. Recruitment will start in September 2025. It will be the first prospective study to evaluate the efficacy of IVO in children, with a high level of evidence provided by its design. If IVO proves effective, it could lengthen the delay in therapeutic escalation to invasive procedures, thereby reducing the risk of complications associated with general anaesthesia in children with neurogenic bladder.
Trial registration
This trial is registered with the European Union (EU) Clinical Trials Information System (CTIS) under EU CT Number: 2022–501 902–36-00 (approved 09.01.2025) and ClinicalTrials.gov under identifier NCT07027020 (registered 18.06.2025).
{"title":"Intravesical oxybutynin for bladder capacity in children with spina bifida: the ‘Place de l’OXybutynine Intravésicale chez le Patient Enfant Neurologique’ (POXIPEN) trial protocol","authors":"Marie Buzzi, Jonathan Epstein, Zahi Hatem, Nadine Juge, Charles Mazeaud, Jean-Louis Lemelle, Nicolas Berte","doi":"10.1111/bju.70058","DOIUrl":"10.1111/bju.70058","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Neurogenic bladder is defined as a dysfunction of the bladder resulting from damage to the central or peripheral nervous systems. Its treatment is based on a progressive therapeutic escalation, rapidly involving invasive therapeutic procedures such as repeated intradetrusor injections and surgery. Given the risk of repeated general anaesthesia in children, there is a need for non-invasive treatment for young patients who do not respond to or have adverse effects from oral anticholinergic treatment. The ‘Place de l’OXybutynine Intravésicale chez le Patient Enfant Neurologique’ (POXIPEN) trial aims to assess the efficacy of intra-vesical oxybutynin on bladder capacity in a sample of French children with neurogenic bladder.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Study Design</h3>\u0000 \u0000 <p>The POXIPEN is a multicentre, randomised, double-blind, placebo-controlled trial.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Endpoints</h3>\u0000 \u0000 <p>The primary outcome is change in maximal bladder capacity after treatment. Secondary outcomes include changes in voiding, urodynamic and ultrasound parameters. We will also assess changes on quality of life and usability of the product.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Patients and Methods</h3>\u0000 \u0000 <p>We aim to randomly assign 60 children with neurogenic bladder secondary to spina bifida and deemed non-responders to first-line treatment with oral anticholinergics, to receive intravesical oxybutynin (IVO) or placebo for 4 weeks. Recruitment will start in September 2025. It will be the first prospective study to evaluate the efficacy of IVO in children, with a high level of evidence provided by its design. If IVO proves effective, it could lengthen the delay in therapeutic escalation to invasive procedures, thereby reducing the risk of complications associated with general anaesthesia in children with neurogenic bladder.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial registration</h3>\u0000 \u0000 <p>This trial is registered with the European Union (EU) Clinical Trials Information System (CTIS) under EU CT Number: 2022–501 902–36-00 (approved 09.01.2025) and ClinicalTrials.gov under identifier NCT07027020 (registered 18.06.2025).</p>\u0000 </section>\u0000 </div>","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 2","pages":"390-398"},"PeriodicalIF":4.4,"publicationDate":"2025-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://bjui-journals.onlinelibrary.wiley.com/doi/epdf/10.1111/bju.70058","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145427760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura Elst, Eduard Roussel, Marija Miletic, Hielke-Martijn De Vries, Rick Verdijk, Sylvia Yan, Hussain Alnajjar, Davide Perri, Aishwarya Kaur, Richard Barry Sirard, Sebastiano Nazzani, Giuseppe Basile, Marco Bandini, João Lobo, Nicola Di Nardo, Georgios Hatzichristodoulou, Andrea Salonia, Alberto Breda, Philippe E. Spiess, Nicola Nicolai, Christian Fankhauser, Arie Parnham, Marco Falcone, Giorgio Bozzini, Asif Muneer, Nick Watkin, Benjamin Ayres, Oscar R. Brouwer, Maarten Albersen, In collaboration with the Young Academic Urologists (YAU) working group on penile and testis cancer
Objectives
To assess local recurrence (LR) and its impact on cancer-specific survival (CSS) in an international multicentric homogeneous cohort of lower-risk patients with penile squamous cell carcinoma (PSCC) that underwent glans-sparing surgery (GSS).
Patients and Methods
We retrospectively studied patients with PSCC treated with circumcision, wide local excision, glans resurfacing, partial glansectomy and laser ablation, collectively defined as GSS. To understand whether LR itself impacts CSS, patients with lymphatic or systemic disease prior or concurrent with LR were excluded. Predictors of LR and its impact on CSS were assessed using Cox proportional hazard regression and Kaplan–Meier survival analysis, respectively.
Results
Across 15 institutions, 550 patients were included. The majority had pathological T1 stage (79%) tumours, reflecting the selection of less invasive tumours for GSS. At a median (interquartile range) follow-up of 41 (23–63) months, 162 (29%) patients experienced LR. LR did not affect cancer-specific mortality and 5-year CSS remained at 99%. Three patients died from penile cancer, none of whom showed a LR during their disease course. The presence of penile intraepithelial neoplasia in the surgical margin was an independent predictor of LR (hazard ratio 2.28, P = 0.02), even after adjusting for additional treatments.
Conclusion
Patients undergoing GSS for PSCC demonstrate excellent survival outcomes, despite LR in 29% of men. These findings support the use of GSS as a safe and effective treatment option for patients committed to adequate follow-up.
{"title":"Local recurrence after glans-sparing surgery: no impact on penile cancer-specific survival","authors":"Laura Elst, Eduard Roussel, Marija Miletic, Hielke-Martijn De Vries, Rick Verdijk, Sylvia Yan, Hussain Alnajjar, Davide Perri, Aishwarya Kaur, Richard Barry Sirard, Sebastiano Nazzani, Giuseppe Basile, Marco Bandini, João Lobo, Nicola Di Nardo, Georgios Hatzichristodoulou, Andrea Salonia, Alberto Breda, Philippe E. Spiess, Nicola Nicolai, Christian Fankhauser, Arie Parnham, Marco Falcone, Giorgio Bozzini, Asif Muneer, Nick Watkin, Benjamin Ayres, Oscar R. Brouwer, Maarten Albersen, In collaboration with the Young Academic Urologists (YAU) working group on penile and testis cancer","doi":"10.1111/bju.70055","DOIUrl":"10.1111/bju.70055","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To assess local recurrence (LR) and its impact on cancer-specific survival (CSS) in an international multicentric homogeneous cohort of lower-risk patients with penile squamous cell carcinoma (PSCC) that underwent glans-sparing surgery (GSS).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Patients and Methods</h3>\u0000 \u0000 <p>We retrospectively studied patients with PSCC treated with circumcision, wide local excision, glans resurfacing, partial glansectomy and laser ablation, collectively defined as GSS. To understand whether LR itself impacts CSS, patients with lymphatic or systemic disease prior or concurrent with LR were excluded. Predictors of LR and its impact on CSS were assessed using Cox proportional hazard regression and Kaplan–Meier survival analysis, respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Across 15 institutions, 550 patients were included. The majority had pathological T1 stage (79%) tumours, reflecting the selection of less invasive tumours for GSS. At a median (interquartile range) follow-up of 41 (23–63) months, 162 (29%) patients experienced LR. LR did not affect cancer-specific mortality and 5-year CSS remained at 99%. Three patients died from penile cancer, none of whom showed a LR during their disease course. The presence of penile intraepithelial neoplasia in the surgical margin was an independent predictor of LR (hazard ratio 2.28, <i>P</i> = 0.02), even after adjusting for additional treatments.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Patients undergoing GSS for PSCC demonstrate excellent survival outcomes, despite LR in 29% of men. These findings support the use of GSS as a safe and effective treatment option for patients committed to adequate follow-up.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 1","pages":"146-153"},"PeriodicalIF":4.4,"publicationDate":"2025-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145427888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ashley C. Rhodes, Kaitlyn A. McClintic, Emily Witt, Ikenna Nwosu, Kyle R. Balk, Colin Reis, Ian C. Sutton, Jianling Bi, Melinda Z. Fu, Michael A. O’Donnell, Vignesh T. Packiam, James D. Byrne
<div> <section> <h3> Objectives</h3> <p>To develop a drug-releasing intravesical floating technology (DRIFT) device for controlled sequential delivery of gemcitabine and docetaxel (Gem/Doce) to optimise the treatment of non-muscle-invasive bladder cancer (NMIBC) while enabling patient mobility and self-removal, as sequential intravesical Gem/Doce has been increasingly utilised but has logistical limitations requiring prolonged clinic visits and patient immobilisation.</p> </section> <section> <h3> Materials and Methods</h3> <p>The DRIFT device features a three-dimensional printed perforated tube with latex sleeve, dissolvable polyvinyl acetate and polyvinylpyrrolidone end cap with adjustable fluorinated polymer (FluoroPel) coating, and patient-removal suture. A 14-F catheter is placed and intravesical gemcitabine is instilled. The deflated DRIFT device is inserted via catheter and inflated with docetaxel and air. The catheter is removed, allowing gemcitabine to dwell temporarily and be voided by the patient. The DRIFT device remains in the bladder and subsequently releases docetaxel in a controlled, delayed fashion, followed by patient removal. Its flexible, buoyant design supports patient mobility and maintains unimpeded urinary flow. Dissolution kinetics were evaluated using methylene blue, device performance was assessed in Merino sheep, and docetaxel tissue penetration was evaluated in rabbit bladder tissue using high-performance liquid chromatography analysis.</p> </section> <section> <h3> Results</h3> <p>The DRIFT device demonstrated adaptable drug release through FluoroPel coating optimisation, with dissolution times extending significantly from zero to three coatings (<i>P</i> < 0.001). Docetaxel release kinetics plateaued between 2.0 and 3.0 mL volumes. Sheep studies revealed similar timed drug release as <i>in vitro</i> testing. Escalating gemcitabine concentrations enhanced docetaxel tissue penetration, with peak concentrations reaching 0.45 vs 0.08 mg/mL in controls. Extended gemcitabine dwell time (up to 4 h) further improved docetaxel delivery, achieving significant enhancement in deep tissue penetration (<i>P</i> < 0.001).</p> </section> <section> <h3> Conclusion</h3> <p>The DRIFT enables controlled sequential delivery of Gem/Doce, reliably maintaining docetaxel containment for up to 120 min during gemcitabine pre-treatment. Future <i>in vivo</i> validation will establish safety and therapeutic potential. This platform has broader applications beyond NMIBC, including urinary tract infections and interstitial cystitis.</p> </s
开发一种药物释放膀胱内漂浮技术（DRIFT）装置，用于控制吉西他滨和多西他赛（Gem/Doce）的顺序递送，以优化非肌肉侵袭性膀胱癌（NMIBC）的治疗，同时使患者能够活动和自我清除，因为顺序膀胱内Gem/Doce的应用越来越多，但存在需要长时间临床就诊和患者固定的逻辑性限制。DRIFT装置的特点是一个三维打印穿孔管，带有乳胶套管，可溶解的聚醋酸乙烯和聚乙烯吡罗烷酮端帽，带有可调节的氟化聚合物（FluoroPel）涂层，以及患者移除缝线。放置14‐F导管，膀胱内灌注吉西他滨。将放气的DRIFT装置通过导管插入并用多西他赛和空气充气。将导管取出，使吉西他滨暂时停留并由患者排出。DRIFT装置留在膀胱内，随后以可控的延迟方式释放多西他赛，随后患者取出。其灵活，浮力设计支持病人的行动和保持畅通无阻的尿流。用亚甲基蓝评估溶出动力学，用高效液相色谱分析评估装置在美利奴羊中的性能，用高效液相色谱分析评估多西紫杉醇在兔膀胱组织中的组织渗透。结果通过FluoroPel包被优化，DRIFT装置表现出适应性药物释放，溶出时间从零到三层显著延长（P < 0.001）。多西紫杉醇释放动力学在2.0和3.0 mL之间趋于稳定。绵羊实验显示了与体外试验相似的药物释放时间。不断增加的吉西他滨浓度增强了多西他赛组织渗透，在对照组中峰值浓度达到0.45 mg/mL vs 0.08 mg/mL。延长吉西他滨停留时间（长达4小时）进一步改善了多西他赛的递送，实现了深层组织渗透的显著增强（P < 0.001）。DRIFT能够控制Gem/Doce的顺序递送，在吉西他滨预处理期间可靠地维持多西他赛的遏制长达120分钟。未来的体内验证将确定安全性和治疗潜力。该平台在NMIBC之外有更广泛的应用，包括尿路感染和间质性膀胱炎。
{"title":"Drug-releasing intravesical floating technology for sequential gemcitabine and docetaxel in non-muscle-invasive bladder cancer","authors":"Ashley C. Rhodes, Kaitlyn A. McClintic, Emily Witt, Ikenna Nwosu, Kyle R. Balk, Colin Reis, Ian C. Sutton, Jianling Bi, Melinda Z. Fu, Michael A. O’Donnell, Vignesh T. Packiam, James D. Byrne","doi":"10.1111/bju.70060","DOIUrl":"10.1111/bju.70060","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To develop a drug-releasing intravesical floating technology (DRIFT) device for controlled sequential delivery of gemcitabine and docetaxel (Gem/Doce) to optimise the treatment of non-muscle-invasive bladder cancer (NMIBC) while enabling patient mobility and self-removal, as sequential intravesical Gem/Doce has been increasingly utilised but has logistical limitations requiring prolonged clinic visits and patient immobilisation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>The DRIFT device features a three-dimensional printed perforated tube with latex sleeve, dissolvable polyvinyl acetate and polyvinylpyrrolidone end cap with adjustable fluorinated polymer (FluoroPel) coating, and patient-removal suture. A 14-F catheter is placed and intravesical gemcitabine is instilled. The deflated DRIFT device is inserted via catheter and inflated with docetaxel and air. The catheter is removed, allowing gemcitabine to dwell temporarily and be voided by the patient. The DRIFT device remains in the bladder and subsequently releases docetaxel in a controlled, delayed fashion, followed by patient removal. Its flexible, buoyant design supports patient mobility and maintains unimpeded urinary flow. Dissolution kinetics were evaluated using methylene blue, device performance was assessed in Merino sheep, and docetaxel tissue penetration was evaluated in rabbit bladder tissue using high-performance liquid chromatography analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The DRIFT device demonstrated adaptable drug release through FluoroPel coating optimisation, with dissolution times extending significantly from zero to three coatings (<i>P</i> < 0.001). Docetaxel release kinetics plateaued between 2.0 and 3.0 mL volumes. Sheep studies revealed similar timed drug release as <i>in vitro</i> testing. Escalating gemcitabine concentrations enhanced docetaxel tissue penetration, with peak concentrations reaching 0.45 vs 0.08 mg/mL in controls. Extended gemcitabine dwell time (up to 4 h) further improved docetaxel delivery, achieving significant enhancement in deep tissue penetration (<i>P</i> < 0.001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The DRIFT enables controlled sequential delivery of Gem/Doce, reliably maintaining docetaxel containment for up to 120 min during gemcitabine pre-treatment. Future <i>in vivo</i> validation will establish safety and therapeutic potential. This platform has broader applications beyond NMIBC, including urinary tract infections and interstitial cystitis.</p>\u0000 </s","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 2","pages":"360-367"},"PeriodicalIF":4.4,"publicationDate":"2025-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://bjui-journals.onlinelibrary.wiley.com/doi/epdf/10.1111/bju.70060","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145427761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhammed Arif İbis, Tet Yap, Maria Satchi, Noman Ghazanfar, Murat Can Karaburun, Omer Onur Cakir, Onder Yaman, Fabio Castiglione
Objectives
To evaluate the clinical necessity and optimal pharmacological strategy for post-cycle therapy (PCT) in recreational anabolic-androgenic steroid (AAS) users with normal pre-cycle reproductive profiles.
Subjects and Methods
This retrospective, dual-centre cohort study included 79 males who had completed ≤6 months of AAS use and had documented normal pre-cycle reproductive hormone levels and semen parameters. Participants were managed with no treatment (NT; expectant monitoring), clomiphene citrate (CC) monotherapy (25 mg/day; selective oestrogen receptor modulation to stimulate gonadotrophin release), or CC + human chorionic gonadotrophin (hCG) (25 mg/day CC + hCG 1500 IU subcutaneously three times weekly; rapid androgen repletion and testicular stimulation). In patients with follicle-stimulating hormone (FSH) <1.5 IU/L, recombinant FSH (rFSH; 75 IU subcutaneously three times weekly) was suggested to promote spermatogenesis. Linear mixed models and logistic regression analyses were used to evaluate group differences and predictors of recovery.
Results
At baseline (T0), 89.9% of patients had erectile dysfunction and 69.7% exhibited azoospermia or severe oligozoospermia. Both pharmacological regimens accelerated hormonal recovery vs NT, with normalisation across groups by Month 6. Seminal recovery was significantly earlier in treated groups: at 12 months (T12), normozoospermia rates were 87.5% in CC + hCG, 69.2% in CC, and 58.6% in NT. Testicular volume increased ≥20% in 70.8% of CC + hCG vs 6.9% of NT. Combined therapy independently predicted normozoospermia (odds ratio [OR] 6.23, 95% confidence interval [CI] 1.32–29.4) and motility recovery (OR 4.85, 95% CI 1.27–18.4). All five men receiving rFSH achieved normozoospermia by T12. Sexual function improved across groups, with faster recovery in treated patients.
Conclusion
Spontaneous hormonal recovery occurs within 6–12 months after AAS cessation, yet PCT facilitates earlier hormonal normalisation. The addition of hCG to CC was associated with superior recovery of semen parameters and testicular volume. These findings underscore the potential short-term benefits of PCT and highlight the need for prospective randomised trials to establish evidence-based treatment protocols.
{"title":"Post-cycle therapy after short-term anabolic-androgenic steroid use: comparative outcomes in recreational bodybuilders","authors":"Muhammed Arif İbis, Tet Yap, Maria Satchi, Noman Ghazanfar, Murat Can Karaburun, Omer Onur Cakir, Onder Yaman, Fabio Castiglione","doi":"10.1111/bju.70059","DOIUrl":"10.1111/bju.70059","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To evaluate the clinical necessity and optimal pharmacological strategy for post-cycle therapy (PCT) in recreational anabolic-androgenic steroid (AAS) users with normal pre-cycle reproductive profiles.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Subjects and Methods</h3>\u0000 \u0000 <p>This retrospective, dual-centre cohort study included 79 males who had completed ≤6 months of AAS use and had documented normal pre-cycle reproductive hormone levels and semen parameters. Participants were managed with no treatment (NT; expectant monitoring), clomiphene citrate (CC) monotherapy (25 mg/day; selective oestrogen receptor modulation to stimulate gonadotrophin release), or CC + human chorionic gonadotrophin (hCG) (25 mg/day CC + hCG 1500 IU subcutaneously three times weekly; rapid androgen repletion and testicular stimulation). In patients with follicle-stimulating hormone (FSH) <1.5 IU/L, recombinant FSH (rFSH; 75 IU subcutaneously three times weekly) was suggested to promote spermatogenesis. Linear mixed models and logistic regression analyses were used to evaluate group differences and predictors of recovery.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>At baseline (T0), 89.9% of patients had erectile dysfunction and 69.7% exhibited azoospermia or severe oligozoospermia. Both pharmacological regimens accelerated hormonal recovery vs NT, with normalisation across groups by Month 6. Seminal recovery was significantly earlier in treated groups: at 12 months (T12), normozoospermia rates were 87.5% in CC + hCG, 69.2% in CC, and 58.6% in NT. Testicular volume increased ≥20% in 70.8% of CC + hCG vs 6.9% of NT. Combined therapy independently predicted normozoospermia (odds ratio [OR] 6.23, 95% confidence interval [CI] 1.32–29.4) and motility recovery (OR 4.85, 95% CI 1.27–18.4). All five men receiving rFSH achieved normozoospermia by T12. Sexual function improved across groups, with faster recovery in treated patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Spontaneous hormonal recovery occurs within 6–12 months after AAS cessation, yet PCT facilitates earlier hormonal normalisation. The addition of hCG to CC was associated with superior recovery of semen parameters and testicular volume. These findings underscore the potential short-term benefits of PCT and highlight the need for prospective randomised trials to establish evidence-based treatment protocols.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"137 1","pages":"154-165"},"PeriodicalIF":4.4,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145374026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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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