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Beyond the Scalpel: Integrating Digital Health and Artificial Intelligence to Refine Stress Urinary Incontinence Treatment Pathways. 超越手术刀:整合数字健康和人工智能,完善压力性尿失禁治疗途径。
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-12 DOI: 10.1002/nau.70184
Arsalan Ikram Shah, Wenjuan Sun, Kunpeng Yang, Yong Wang
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引用次数: 0
Does Supramaximum Force Exist? Who Can Prove It? 超极力存在吗?谁能证明?
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-05 DOI: 10.1002/nau.70194
Laira Ramos
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引用次数: 0
Significance of Repeat Trial Without Catheter in Patients With Urinary Retention Who Failed the First Attempt at Trial Without Catheter: A 10-Year Retrospective Study. 一次无导管试验失败的尿潴留患者重复无导管试验的意义:一项10年回顾性研究
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-09 DOI: 10.1002/nau.70202
Masato Takanashi, Hiroki Ito, Kazuhide Makiyama, Kazuki Kobayashi
<p><strong>Introduction: </strong>Trial without catheter (TWOC) is used to determine whether patients with acute urinary retention can achieve a catheter-free status. In clinical practice, it is common to repeat TWOC in patients who fail to void without a catheter during the first TWOC attempt. We investigated the outcomes and significance of repeat TWOC in male and female patients and aimed to identify predictors of successful outcomes of repeat TWOC based on patient backgrounds.</p><p><strong>Material and methods: </strong>Patients with acute urinary retention who underwent TWOC at a single center between 2010 and 2019 were enrolled and retrospectively analyzed. In the TWOC, the urinary catheter was removed after the instillation of warm saline (200-300 mL), and residual urine was measured after the first void. The trial was defined as unsuccessful if the patient had difficulty in voiding because of abdominal discomfort or pain. The decision to repeat the TWOC in patients who failed the first trial was made by each physician. Patients were divided into the single-trial and repeat-trial groups, and clinical factors predicting successful outcomes for each TWOC were analyzed using a multivariate logistic regression model.</p><p><strong>Results: </strong>Overall, 681 consecutive patients (577 male and 104 female) were diagnosed with acute urinary retention and underwent TWOC. Among the 577 male patients, 441 (76.4%) underwent TWOC only once (single-trial group), and 136 (23.6%) underwent TWOC twice or more (repeat-trial group). Among the 104 female patients, 84 (80.8%) and 20 (19.2%) underwent single and repeat TWOC, respectively. The overall success rate of TWOC for the single-trial and repeat-trial groups was not significantly different in either sex: 61.9% (273/441, single trial) and 55.1% (75/136, repeat trial) in male patients (p = 0.159) and 58.3% (49/84, single trial) and 55.0% (11/20, repeat trial) in female patients (p = 0.786). In the repeat-trial group, no significant and independent predictor of successful TWOC was found. In the single-trial group, low Eastern Cooperative Oncology Group performance status (odds ratio: 1.79 [1.1-2.9], p = 0.019) was identified as an independent predictor of a successful trial and absence of dementia (odds ratio: 3.82 [0.71-20.46], p = 0.118) was a possible predictor in male patients, whereas a high serum albumin level (odds ratio: 0.55 [0.27-1.15], p = 0.113) was a possible predictor of a successful trial in female patients.</p><p><strong>Conclusions: </strong>This is the first study to show the importance of repeated TWOC in male and female patients. The equivalent success rate of TWOC in the single and repeat TWOC groups for male and female patients indicates that repeat TWOC is justified as well as single TWOC, suggesting the importance of attempting repeat TWOC in patients of both sexes. This study also showed that predicting successful TWOC based on patient characteristics is difficult in repeat TWO
简介:试验无导管(TWOC)用于确定急性尿潴留患者是否可以达到无导管状态。在临床实践中,在第一次TWOC尝试时没有导管排空失败的患者重复TWOC是很常见的。我们调查了男性和女性患者重复TWOC的结果和意义,旨在根据患者背景确定重复TWOC成功结果的预测因素。材料和方法:纳入2010年至2019年在单一中心接受TWOC治疗的急性尿潴留患者并进行回顾性分析。TWOC组在输注温生理盐水(200-300 mL)后拔除导尿管,第一次排空后测量残余尿量。如果患者因腹部不适或疼痛而排尿困难,则该试验被定义为不成功。在第一次试验失败的患者中重复TWOC的决定是由每位医生做出的。将患者分为单试验组和重复试验组,采用多因素logistic回归模型分析预测两组患者成功结局的临床因素。结果:总体而言,681例连续患者(577例男性,104例女性)被诊断为急性尿潴留并接受了TWOC治疗。577例男性患者中,441例(76.4%)仅接受了一次TWOC(单试验组),136例(23.6%)接受了两次或两次以上TWOC(重复试验组)。104例女性患者中,84例(80.8%)和20例(19.2%)分别接受了单次和重复TWOC。单试验组和重复试验组的TWOC总成功率男女差异无统计学意义:男性患者61.9%(273/441,单试验)和55.1%(75/136,重复试验)(p = 0.159),女性患者58.3%(49/84,单试验)和55.0%(11/20,重复试验)(p = 0.786)。在重复试验组中,没有发现TWOC成功的显著和独立的预测因子。在单试验组中,较低的东部肿瘤合作组表现状态(优势比:1.79 [1.1-2.9],p = 0.019)被确定为试验成功的独立预测因素,无痴呆(优势比:3.82 [0.71-20.46],p = 0.118)是男性患者的可能预测因素,而高血清白蛋白水平(优势比:0.55 [0.27-1.15],p = 0.113)是女性患者试验成功的可能预测因素。结论:这是第一个显示重复TWOC在男性和女性患者中的重要性的研究。男性和女性患者在单一和重复TWOC组中相同的成功率表明,重复TWOC与单一TWOC一样是合理的,这表明在两性患者中尝试重复TWOC的重要性。该研究还表明,基于患者特征预测成功的两次TWOC在重复TWOC中是困难的,但在第一次TWOC中是可能的。临床试验注册:我们的研究是一项观察性研究,不是临床试验,因此不需要注册。
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引用次数: 0
The Mediating Role of Depression in the Association Between Food Insecurity and Lower Urinary Tract Symptoms in Middle-Aged and Older Men: A Population-Based Study. 抑郁在中老年男性食物不安全与下尿路症状之间的中介作用:一项基于人群的研究
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-15 DOI: 10.1002/nau.70209
Meixiang Han, Cailiu Wei, Yong Fang, Yiqi Huang, Yanling Zhang, Zhongjie Qu, Fenjuan Chen

Objective: This study aimed to explore the association between food insecurity (FI) and lower urinary tract symptoms (LUTS) in middle-aged and older men, and to evaluate the mediating role of depression in this relationship.

Methods: Data were drawn from the National Health and Nutrition Examination Survey (NHANES) 2005-2008, including 2777 men aged 40 years and older. FI was assessed using the Household Food Security Survey Module, depression was measured by the PHQ-9 scale, and LUTS were identified via symptoms such as hesitancy, incomplete bladder emptying, incontinence, and nocturia. Weighted logistic regression and restricted cubic spline models were applied to assess associations. Mediation analysis was conducted using depression as a mediator.

Results: After full adjustment, FI was significantly associated with higher odds of incomplete bladder emptying (OR = 1.94, 95% CI: 1.11-3.36), urinary incontinence (OR = 2.11, 95% CI: 1.44-3.09), nocturia (OR = 1.59, 95% CI: 1.11-2.29), and clinical LUTS (OR = 2.49, 95% CI: 1.63-3.80). Moreover, higher PHQ-9 scores were consistently associated with increased odds of all types of LUTS, including urinary hesitancy, incomplete bladder emptying, urinary incontinence, nocturia, and clinical LUTS, in a dose-dependent manner. Mediation analysis indicated that depression partially mediated the association between FI and LUTS. Specifically, depression accounted for 12.22% of the effect of FI on urinary hesitancy, 8.90% on incomplete bladder emptying, 9.90% on urinary incontinence, 7.74% on nocturia, and 6.69% on clinical LUTS (all p < 0.05). These results demonstrate that depression plays a modest but statistically significant mediating role in the pathway linking FI to LUTS.

Conclusions: FI is significantly associated with multiple LUTS among middle-aged and older men, with depression partially mediating this relationship. Addressing both food access and mental health, particularly depression, may be critical for mitigating LUTS burden in this population.

Clinical trial registration number: Our study does not require a clinical trial registration. The survey data of our study are publicly available on the internet for data users and researchers throughout the world (https://www.cdc.gov/nchs/nhanes/?CDC_AAref_Val=https://www.cdc.gov/nchs/nhanes/index.htm).

目的:本研究旨在探讨中老年男性食物不安全(FI)与下尿路症状(LUTS)的关系,并评估抑郁在这一关系中的中介作用。方法:数据来自2005-2008年国家健康与营养调查(NHANES),包括2777名年龄在40岁及以上的男性。FI采用家庭食品安全调查模块进行评估,抑郁症采用PHQ-9量表进行测量,LUTS通过犹豫、膀胱排空不全、大小便失禁和夜尿等症状进行识别。加权逻辑回归和限制三次样条模型用于评估相关性。以抑郁为中介进行中介分析。结果:完全调整后,FI与膀胱排空不完全(OR = 1.94, 95% CI: 1.11-3.36)、尿失禁(OR = 2.11, 95% CI: 1.44-3.09)、夜尿症(OR = 1.59, 95% CI: 1.11-2.29)和临床LUTS (OR = 2.49, 95% CI: 1.63-3.80)的发生率显著相关。此外,较高的PHQ-9评分始终与所有类型LUTS的发生率增加相关,包括尿犹豫、膀胱排空不全、尿失禁、夜尿症和临床LUTS,并呈剂量依赖性。中介分析表明,抑郁在FI与LUTS之间起部分中介作用。其中,抑郁症在FI对尿犹豫的影响中占12.22%,在膀胱排空不全的影响中占8.90%,在尿失禁中占9.90%,在夜尿症中占7.74%,在临床LUTS中占6.69%(均为p)。结论:FI与中老年男性多发性LUTS显著相关,抑郁症在其中起部分作用。解决食物获取和心理健康问题,特别是抑郁症问题,可能对减轻这一人群的LUTS负担至关重要。临床试验注册号:我们的研究不需要临床试验注册。我们研究的调查数据在互联网上公开,供全世界的数据用户和研究人员使用(https://www.cdc.gov/nchs/nhanes/?CDC_AAref_Val=https://www.cdc.gov/nchs/nhanes/index.htm)。
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引用次数: 0
Considerations for Videourodynamics and How It Impacts Practice. 视频尿动力学的注意事项及其如何影响练习。
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-08-05 DOI: 10.1002/nau.70120
Casey Kowalik, Richard Fantus, Colby Souders

Aims: Provide urologists with a comprehensive understanding to guide the optimal and evidence-based utilization of VUDS in contemporary practice.

Methods: We performed a literature review of VUDS use in modern-day urologic practice, as well as innovative technological advancements and research endeavors to improve VUDS.

Results: VUDS offers enhanced diagnostic precision, which directly influences treatment planning and can lead to more tailored and effective therapies. The increased resource intensity of VUDS underscores the critical need for appropriate patient selection. Contrast-enhanced voiding ultrasonography (ceVUS), using microbubble contrast agents, shows promise for eliminating the need for radiation through fluoroscopy in the identification of vesicoureteral reflux. Further, artificial intelligence holds considerable potential to transform various aspects of VUDS.

Conclusions: VUDS is a diagnostic tool for complex lower urinary tract dysfunction (LUTD) where UDS findings are insufficient or where detailed anatomical information is paramount for safe and effective treatment planning.

目的:为泌尿科医师提供全面的认识,以指导当代临床实践中VUDS的最佳循证应用。方法:我们回顾了VUDS在现代泌尿外科实践中的应用,以及改进VUDS的创新技术进展和研究努力。结果:VUDS提供了更高的诊断精度,直接影响治疗计划,可以带来更有针对性和更有效的治疗。VUDS资源强度的增加强调了对适当患者选择的迫切需要。使用微泡造影剂的对比增强排尿超声检查(ceVUS)有望在识别膀胱输尿管反流时消除透视放射的需要。此外,人工智能在改变VUDS的各个方面具有相当大的潜力。结论:VUDS是复杂下尿路功能障碍(LUTD)的诊断工具,在这种情况下,UDS的发现不足,或者详细的解剖信息对于安全有效的治疗计划至关重要。
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引用次数: 0
Sarcopenia as a Predictor of Pelvic Organ Prolapse in Women: A Retrospective Study Using the Psoas-Lumbar Vertebral Index. 肌肉减少症是女性盆腔器官脱垂的一个预测指标:使用腰肌-腰椎指数的回顾性研究。
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-03 DOI: 10.1002/nau.70204
Sinharib Citgez, Kadir Can Sahin, Feyyaz Irmak, Mehmet Hamza Gultekin, Duhan Enes Tel, Muhammet Demirbilek, Goktug Kalender

Introduction: Pelvic organ prolapse (POP) is a prevalent condition among older women, often linked to weakened pelvic floor muscles. Sarcopenia, characterized by age-related loss of muscle mass and function, may contribute to the pathophysiology of POP. However, the association between sarcopenia and POP remains unclear. This study aims to investigate the relationship between sarcopenia and POP using the psoas-lumbar vertebral index (PLVI) as an objective, practical, imaging-based assessment.

Materials and methods: A retrospective analysis was conducted on patients who presented to the functional urology outpatient clinic between March 2022 and March 2024. Patients were categorized into two groups: those with severe POP requiring surgical intervention and those without POP. PLVI was measured using computed tomography (CT) scans at the L4 vertebral level. Demographic data, and clinical characteristics results were compared between groups. Logistic regression models assessed predictors of POP, testing linearity of PLVI using restricted cubic splines. Model discrimination, calibration, and clinical utility were evaluated by receiver operating characteristic (ROC) analysis, Hosmer-Lemeshow test, and decision-curve analysis. A sensitivity analysis restricted to CTs ≤ 3 months was also performed.

Results: A total of 112 patients were analyzed (64 with POP, 48 controls). PLVI values were significantly lower in the POP group (p = 0.021). In multivariable analysis, previous pelvic surgery (OR 0.53, p = 0.011), positive provocative stress test (OR: 4.73, p < 0.001), and lower PLVI (OR: 0.18, p = 0.032) were independently associated with POP. The model showed acceptable calibration (Hosmer-Lemeshow χ² = 15.97, p = 0.06) and moderate discrimination (AUC = 0.627, 95% CI: 0.522-0.733). Sensitivity analysis yielded consistent results.

Conclusion: This study highlights a significant association between sarcopenia, as measured by PLVI, and POP. PLVI offers an objective, easily accessible, imaging-based metric for sarcopenia evaluation in patients with POP. Given these findings, incorporating sarcopenia assessment into POP management may enhance clinical decision-making and optimize patient outcomes with multidisciplinary approach.

Clinical trial registration: Since our study is a retrospective data analysis, clinical trial registration is not required.

盆腔器官脱垂(POP)是老年妇女的一种常见疾病,通常与盆底肌肉减弱有关。肌肉减少症的特征是与年龄相关的肌肉质量和功能的丧失,可能导致POP的病理生理。然而,肌少症与POP之间的关系尚不清楚。本研究旨在利用腰肌-腰椎指数(PLVI)作为客观、实用、基于影像学的评估,探讨肌肉减少症与POP之间的关系。材料与方法:回顾性分析2022年3月至2024年3月在泌尿功能科门诊就诊的患者。患者分为两组:需要手术干预的严重POP组和无POP组。使用计算机断层扫描(CT)在L4椎体水平测量PLVI。组间人口学资料及临床特征结果比较。Logistic回归模型评估了POP的预测因子,使用受限三次样条检验PLVI的线性。采用受试者工作特征(ROC)分析、Hosmer-Lemeshow检验和决策曲线分析评估模型判别、校正和临床应用。对ct≤3个月的患者进行敏感性分析。结果:共分析112例患者(64例为POP, 48例为对照组)。PLVI值显著低于POP组(p = 0.021)。在多变量分析中,既往盆腔手术(OR 0.53, p = 0.011),阳性刺激应激测试(OR: 4.73, p)结论:本研究强调了PLVI测量的肌肉减少症与POP之间的显著关联。PLVI为POP患者的肌肉减少症评估提供了一个客观、容易获取、基于成像的指标。鉴于这些发现,将肌少症评估纳入POP管理可能会加强临床决策,并通过多学科方法优化患者预后。临床试验注册:由于我们的研究是回顾性数据分析,因此不需要临床试验注册。
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引用次数: 0
Assessment of Overactive Bladder in Women With Fibromyalgia Presenting With Lower Urinary Tract Symptoms: A Controlled Clinical Study. 以下尿路症状为表现的纤维肌痛患者膀胱过度活动的评估:一项对照临床研究
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-03 DOI: 10.1002/nau.70206
Duygu Kurtulus, Kevser Arkan, Ferhat Yakup Suceken, Sedat Akgol, Behzat Can

Introduction: Fibromyalgia (FM) is a chronic pain disorder frequently accompanied by lower urinary tract symptoms (LUTS), yet the prevalence and clinical relevance of overactive bladder (OAB) in this population remain poorly defined. This study aimed to evaluate the prevalence of OAB among women with FM and to compare their clinical features with non-FM controls presenting with similar urinary complaints.

Methods: This cross-sectional controlled study included 232 women aged 18-65 years: 192 diagnosed with FM and 40 age- and symptom-matched controls. OAB was diagnosed based on International Continence Society (ICS) criteria using the Overactive Bladder Awareness Tool Version 8 (OAB-V8; cut-off ≥ 8) and a 3-day bladder diary. FM symptom burden was assessed using the Widespread Pain Index (WPI), Symptom Severity Scale (SSS), and General Symptom Score (GSS). Psychiatric comorbidities and irritable bowel syndrome (IBS) were also recorded.

Results: OAB was identified in 62.0% of FM patients and 28.6% of controls (p < 0.001). FM + OAB patients were significantly older and had longer disease duration than FM-OAB patients (p < 0.001). WPI, SSS, and GSS scores were significantly higher in FM + OAB compared to both FM-OAB and control+OAB groups (p < 0.001). Psychiatric comorbidities, IBS, and obesity were also more frequent in FM + OAB. Moderate correlations were observed between OAB and FM symptom severity (ρ = 0.33-0.42, p < 0.01).

Conclusions: OAB is highly prevalent and clinically relevant among women with FM. Its presence is associated with greater symptom severity and comorbid burden, supporting the hypothesis that OAB in FM may represent a manifestation of central sensitization.

纤维肌痛(FM)是一种慢性疼痛疾病,经常伴有下尿路症状(LUTS),然而膀胱过动症(OAB)在这一人群中的患病率和临床相关性仍然不明确。本研究旨在评估FM女性中OAB的患病率,并将其临床特征与有类似泌尿系统疾病的非FM对照进行比较。方法:这项横断面对照研究包括232名年龄在18-65岁之间的女性:192名诊断为FM, 40名年龄和症状匹配的对照组。OAB是根据国际尿失禁协会(ICS)的标准诊断的,使用的是膀胱过度活动意识工具版本8 (OAB- v8;截止值≥8)和3天膀胱日记。采用广泛疼痛指数(WPI)、症状严重程度量表(SSS)和一般症状评分(GSS)评估FM症状负担。精神合并症和肠易激综合征(IBS)也被记录。结果:62.0%的FM患者和28.6%的对照组中存在OAB(结论:OAB在FM女性患者中非常普遍且具有临床相关性)。它的存在与更严重的症状和合并症负担有关,支持了FM中OAB可能代表中枢致敏的假设。
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引用次数: 0
Trends in the Treatment of Stress Urinary Incontinence in a Tertiary Care Center After the Introduction of Polyacrylamide Hydrogel. 聚丙烯酰胺水凝胶在三级护理中心应用后治疗压力性尿失禁的趋势。
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-09 DOI: 10.1002/nau.70205
Madeleine L Burg, Alice Drain, Alexandra Mardock, Victor W Nitti

Introduction: For women with bothersome stress urinary incontinence (SUI), a urethral sling is the gold-standard surgical treatment. Despite the high efficacy of slings for SUI, up to a 20%-30% rate of complications or adverse effects have been reported, and there can be a period of convalescence postoperatively. Given this, the less invasive approach of urethral bulking may be utilized. A number of bulking agents can be used to improve urethra coaptation. Polyacrylamide hydrogel (PAHG) is a bulking agent that received FDA approval in 2020 and is reported to have longer efficacy for the treatment of SUI compared to prior bulking agents. We sought to assess trends in the usage of surgery and urethral bulking for SUI treatment in women at a single academic medical center before and after the introduction of PAHG.

Methods: This is a retrospective cohort study of all new patients seen with an ICD-10 diagnosis of SUI (N39.3) at an academic tertiary care center from June 2019 to June 2023. Our multidisciplinary clinic was established in May 2019. Patients were included if they underwent an interventional treatment for SUI with urethral bulking, sling (either mesh or autologous fascia), or Burch colposuspension. Patients were stratified to before and after the introduction of PAHG to our clinic in April 2021. The primary endpoint was the percent of new patients seen in clinic with SUI who were treated with urethral bulking compared to surgical treatment.

Results: A total of 478 new patients with SUI were seen and 279 treated with an invasive procedure by 5 URPS trained surgeons. In total, 109 of these patients underwent treatment in the 20 months before PAHG was introduced into the clinic and 170 patients in the 27 months after. Use of urethral bulking for new patients seen for SUI increased from 56% to 69.1% (p = 0.04) of patients with SUI who underwent a procedure. When the total number of new patients presenting with a diagnosis of SUI was analyzed by 12-month period, there was an overall increase in the number of procedures for SUI, which was driven by an increase in the percent of new patients who were treated with bulking.

Conclusions: The introduction of a PAHG resulted in increased utilization of urethral bulking for patients newly presenting with SUI to a tertiary care center.

导读:对于患有压力性尿失禁(SUI)的女性,尿道吊带是金标准的手术治疗方法。尽管吊带治疗SUI的疗效很高,但据报道高达20%-30%的并发症或不良反应发生率,并且术后可能有一段恢复期。鉴于此,可以采用侵入性较小的尿道膨胀方法。许多膨胀剂可用于改善尿道覆盖。聚丙烯酰胺水凝胶(PAHG)是一种填充剂,于2020年获得FDA批准,据报道,与之前的填充剂相比,它在治疗SUI方面的疗效更长。我们试图评估在引入PAHG之前和之后,在单一学术医疗中心使用手术和尿道膨胀治疗女性SUI的趋势。方法:这是一项回顾性队列研究,纳入了2019年6月至2023年6月在一家学术三级医疗中心诊断为SUI (N39.3)的所有ICD-10新患者。我们的多学科诊所成立于2019年5月。如果患者接受了SUI的介入治疗,包括尿道膨胀、吊带(网状或自体筋膜)或Burch阴道悬吊。我们于2021年4月将患者分为引入PAHG前后两组。研究的主要终点是与手术治疗相比,接受尿道膨胀治疗的SUI临床新患者的百分比。结果:共有478例SUI新患者,其中279例由5名URPS培训过的外科医生进行有创手术治疗。总共有109名患者在PAHG引入临床前20个月接受了治疗,170名患者在引入临床后27个月接受了治疗。在接受手术的SUI患者中,新患者使用尿道膨胀术的比例从56%增加到69.1% (p = 0.04)。当对诊断为SUI的新患者总数进行12个月的分析时,SUI的手术数量总体上有所增加,这是由接受膨胀治疗的新患者百分比的增加所驱动的。结论:PAHG的引入增加了新出现SUI患者在三级医疗中心的尿道膨胀使用率。
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引用次数: 0
Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial. 膀胱功能和Vibegron在接受良性前列腺增生治疗的膀胱过度活动男性患者中的安全性:来自3期随机对照COURAGE试验的结果
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-09 DOI: 10.1002/nau.70199
Eric S Rovner, Janet Owens-Grillo, Elizabeth Thomas, Sender Herschorn, Kenneth M Peters, David Staskin, Salim Mujais

Purpose: Vibegron was associated with improvements in efficacy versus placebo and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH) in the COURAGE trial (NCT03902080). Additional safety, bladder function, and urodynamics data are provided.

Methods: This 24-week, phase 3, double-blind, placebo-controlled trial randomized men ≥ 45 years with OAB and BPH receiving α-blocker ± 5α-reductase inhibitors to once-daily vibegron or placebo (1:1). From the safety analysis set (SAF), postvoid residual urine volume (PVR), maximum urinary flow rate (Uroflow-Qmax), International Prostate Symptom Score (IPSS) total score, and urologic-related adverse events (AEs) were collected throughout the trial. Qmax and detrusor pressure at Qmax (PdetQmax) were collected at baseline and week 12 in a urodynamics substudy (urodynamics evaluable set [UES]).

Results: In the SAF, differences between vibegron (n = 553) and placebo (n = 551) in PVR and Uroflow-Qmax were minimal at baseline, week 12, and week 24. Mean (SD) change from baseline (CFB) at week 24 in IPSS total score was -7.3 (6.96) with vibegron and -5.7 (7.14) with placebo. Urinary retention was reported as an AE for 5 (0.9%) and 4 (0.7%) participants receiving vibegron and placebo, respectively. In the UES (vibegron, n = 21; placebo, n = 22), least squares mean difference (95% CI) between vibegron and placebo in CFB at week 12 was 2.75 (0.16, 5.34) mL/s in Qmax and 2.86 (-13.52, 19.25) cmH2O in PdetQmax.

Conclusions: There were no safety signals related to bladder function identified by urodynamics; risk of protocol-defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population.

Clinical trial registration: This study is registered at www.

Clinicaltrials: gov. The registration identification number is NCT03902080.

目的:在COURAGE试验(NCT03902080)中,Vibegron与安慰剂相比,疗效有所改善,并且在膀胱过动症(OAB)患者接受良性前列腺增生(BPH)药物治疗时耐受性良好。提供了额外的安全性、膀胱功能和尿动力学数据。方法:这项为期24周的3期双盲安慰剂对照试验将≥45岁的OAB和BPH患者随机分组,接受α-阻滞剂±5α-还原酶抑制剂治疗,每日1次或安慰剂(1:1)。从安全性分析集(SAF)中,收集整个试验期间的空后残留尿量(PVR)、最大尿流率(Uroflow-Qmax)、国际前列腺症状评分(IPSS)总分和泌尿相关不良事件(ae)。在尿动力学亚研究(尿动力学可评估集[UES])中,在基线和第12周收集Qmax和Qmax逼尿肌压力(PdetQmax)。结果:在SAF中,vibegron (n = 553)和安慰剂(n = 551)在PVR和Uroflow-Qmax中的差异在基线、第12周和第24周时最小。第24周时,vibegron组IPSS总分与基线相比的平均(SD)变化为-7.3(6.96),安慰剂组为-5.7(7.14)。分别有5名(0.9%)和4名(0.7%)接受vibegron和安慰剂的受试者报告尿潴留为AE。在UES中(vibegron, n = 21;安慰剂,n = 22),第12周时vibegron和安慰剂在CFB中的最小二乘平均差值(95% CI)为Qmax 2.75 (0.16, 5.34) mL/s, PdetQmax 2.86 (-13.52, 19.25) cmH2O。结论:尿动力学未发现与膀胱功能相关的安全信号;在该人群中,与安慰剂相比,vibegron未增加方案定义的尿潴留或残余尿量增加的不良事件的风险。临床试验注册:本研究注册网址:www.Clinicaltrials: gov,注册识别号:NCT03902080。
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引用次数: 0
Urodynamics for Female Stress Urinary Incontinence: When and Why. 女性压力性尿失禁的尿动力学:时间和原因。
IF 1.9 3区 医学 Q3 UROLOGY & NEPHROLOGY Pub Date : 2026-02-01 Epub Date: 2025-05-12 DOI: 10.1002/nau.70073
Courtney K Pfeuti, Mikolaj Przydacz, Brian J Linder

Aims: To discuss the use of urodynamic testing for female stress urinary incontinence and provide a narrative review of the current evidence regarding the utility of urodynamics across the spectrum of clinical presentations.

Methods: A nonsystemic, extensive literature review via PubMed was performed on the use of urodynamics for female stress urinary incontinence.

Results: Findings from several large multicenter trials and subsequent secondary analyses have significantly influenced treatment patterns away from the routine use of urodynamics in female patients with uncomplicated stress urinary incontinence. Much of the current literature focuses on selected patients with uncomplicated stress urinary incontinence that are subsequently treated with midurethral sling placement. These studies comprise the foundational evidence supporting multiple national and international guidelines on the topic. In uncomplicated patients, these guidelines do not support the routine use of urodynamics. However, in more complicated presentations, urodynamic studies are more often valuable for diagnosis and management.

Conclusions: Routine use of urodynamic testing is not currently recommended in guidelines for evaluating uncomplicated female stress urinary incontinence. It is important to recognize that much of the evidence supporting these recommendations is derived from a select population of uncomplicated patients, which may limit generalizability to more complex cases. In such cases, urodynamic testing may be more useful to guide diagnosis and management, though further research is needed to identify which findings have the greatest impact on clinical outcomes.

目的:讨论尿动力学检测在女性压力性尿失禁中的应用,并对尿动力学在临床表现中的应用进行综述。方法:通过PubMed对尿动力学在女性压力性尿失禁中的应用进行了非系统的、广泛的文献回顾。结果:几项大型多中心试验和随后的二次分析的结果显著影响了非复杂性压力性尿失禁女性患者常规使用尿动力学的治疗模式。目前的文献大多集中在选择无并发症的压力性尿失禁患者,随后用尿道中吊带放置治疗。这些研究构成了支持有关该主题的多个国家和国际指南的基础证据。对于无并发症的患者,这些指南不支持常规使用尿动力学。然而,在更复杂的情况下,尿动力学研究对诊断和治疗更有价值。结论:目前在评估无并发症的女性压力性尿失禁的指南中不建议常规使用尿动力学测试。重要的是要认识到,支持这些建议的大部分证据来自于非复杂患者的精选人群,这可能限制了对更复杂病例的推广。在这种情况下,尿动力学测试可能对指导诊断和治疗更有用,尽管需要进一步的研究来确定哪些发现对临床结果有最大的影响。
{"title":"Urodynamics for Female Stress Urinary Incontinence: When and Why.","authors":"Courtney K Pfeuti, Mikolaj Przydacz, Brian J Linder","doi":"10.1002/nau.70073","DOIUrl":"10.1002/nau.70073","url":null,"abstract":"<p><strong>Aims: </strong>To discuss the use of urodynamic testing for female stress urinary incontinence and provide a narrative review of the current evidence regarding the utility of urodynamics across the spectrum of clinical presentations.</p><p><strong>Methods: </strong>A nonsystemic, extensive literature review via PubMed was performed on the use of urodynamics for female stress urinary incontinence.</p><p><strong>Results: </strong>Findings from several large multicenter trials and subsequent secondary analyses have significantly influenced treatment patterns away from the routine use of urodynamics in female patients with uncomplicated stress urinary incontinence. Much of the current literature focuses on selected patients with uncomplicated stress urinary incontinence that are subsequently treated with midurethral sling placement. These studies comprise the foundational evidence supporting multiple national and international guidelines on the topic. In uncomplicated patients, these guidelines do not support the routine use of urodynamics. However, in more complicated presentations, urodynamic studies are more often valuable for diagnosis and management.</p><p><strong>Conclusions: </strong>Routine use of urodynamic testing is not currently recommended in guidelines for evaluating uncomplicated female stress urinary incontinence. It is important to recognize that much of the evidence supporting these recommendations is derived from a select population of uncomplicated patients, which may limit generalizability to more complex cases. In such cases, urodynamic testing may be more useful to guide diagnosis and management, though further research is needed to identify which findings have the greatest impact on clinical outcomes.</p>","PeriodicalId":19200,"journal":{"name":"Neurourology and Urodynamics","volume":" ","pages":"254-261"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Neurourology and Urodynamics
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