Steven Bernstein, Marc Schwartz, Kimberly Becker Ifantides
{"title":"使用减少注射部位范例治疗膀胱过度活动的患者对肉毒杆菌毒素的持久性:一项回顾性图表回顾研究。","authors":"Steven Bernstein, Marc Schwartz, Kimberly Becker Ifantides","doi":"10.1002/nau.25634","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>OnabotulinumtoxinA (onabotA) is an approved treatment for overactive bladder (OAB). This chart review study aims to determine treatment persistence in patients receiving onabotA (100 U) via a reduced injection-site paradigm distributed across ≤ 3 injection sites.</p><p><strong>Methods: </strong>This study was a single site, noninterventional, retrospective chart review evaluating adult female OAB patients refractory to behavioral modification and pharmacotherapy before receiving ≥ 1 treatment with onabotA (100 U) via 1-3 injections between July 2017 and June 2021. Patients with neurologic OAB, predominance of stress incontinence, or who expired during the study were excluded. Baseline demographics, treatment patterns, treatment persistence, treatment intervals, lidocaine pretreatment, patient-reported treatment response, and adverse urological events were documented and evaluated. Persistence was defined as the percent of patients receiving ≥ 3 treatments during the study period via three or fewer injections. Continuous variables were summarized with sample size, mean (standard deviation [SD]), and median (1st and 3rd quartiles); categorical variables were calculated as frequencies and percentages.</p><p><strong>Results: </strong>Of the 90 patients included in this study, 55 (61.1%) were persistent to treatment with onabotA for OAB, completing 3 treatments by the end of the data collection period. Urinary tract infection (UTI) was reported after 18/370 (4.9%) treatments. Of 90 patients,15 (16.7%) reported UTI after any treatment, and none required clean intermittent catheterization.</p><p><strong>Conclusion: </strong>When onabotA was administered via a reduced injection-site paradigm, 61.1% of patients were persistent to OAB treatment. Given the limited pool of patients included in this study and relatively low sample sizes at later timepoints, results may not be generalizable. No new safety signals were identified using the reduced injection-site paradigm.</p><p><strong>Clinical trial registration: </strong>Due to the nature of this study, no clinical trial registration was required.</p>","PeriodicalId":19200,"journal":{"name":"Neurourology and Urodynamics","volume":" ","pages":"338-344"},"PeriodicalIF":1.8000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Patient Persistence to OnabotulinumtoxinA Treatment for Overactive Bladder Using a Reduced Injection-Site Paradigm: A Retrospective Chart Review Study.\",\"authors\":\"Steven Bernstein, Marc Schwartz, Kimberly Becker Ifantides\",\"doi\":\"10.1002/nau.25634\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>OnabotulinumtoxinA (onabotA) is an approved treatment for overactive bladder (OAB). This chart review study aims to determine treatment persistence in patients receiving onabotA (100 U) via a reduced injection-site paradigm distributed across ≤ 3 injection sites.</p><p><strong>Methods: </strong>This study was a single site, noninterventional, retrospective chart review evaluating adult female OAB patients refractory to behavioral modification and pharmacotherapy before receiving ≥ 1 treatment with onabotA (100 U) via 1-3 injections between July 2017 and June 2021. Patients with neurologic OAB, predominance of stress incontinence, or who expired during the study were excluded. Baseline demographics, treatment patterns, treatment persistence, treatment intervals, lidocaine pretreatment, patient-reported treatment response, and adverse urological events were documented and evaluated. Persistence was defined as the percent of patients receiving ≥ 3 treatments during the study period via three or fewer injections. Continuous variables were summarized with sample size, mean (standard deviation [SD]), and median (1st and 3rd quartiles); categorical variables were calculated as frequencies and percentages.</p><p><strong>Results: </strong>Of the 90 patients included in this study, 55 (61.1%) were persistent to treatment with onabotA for OAB, completing 3 treatments by the end of the data collection period. Urinary tract infection (UTI) was reported after 18/370 (4.9%) treatments. Of 90 patients,15 (16.7%) reported UTI after any treatment, and none required clean intermittent catheterization.</p><p><strong>Conclusion: </strong>When onabotA was administered via a reduced injection-site paradigm, 61.1% of patients were persistent to OAB treatment. Given the limited pool of patients included in this study and relatively low sample sizes at later timepoints, results may not be generalizable. No new safety signals were identified using the reduced injection-site paradigm.</p><p><strong>Clinical trial registration: </strong>Due to the nature of this study, no clinical trial registration was required.</p>\",\"PeriodicalId\":19200,\"journal\":{\"name\":\"Neurourology and Urodynamics\",\"volume\":\" \",\"pages\":\"338-344\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurourology and Urodynamics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/nau.25634\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/12/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurourology and Urodynamics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/nau.25634","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/11 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Patient Persistence to OnabotulinumtoxinA Treatment for Overactive Bladder Using a Reduced Injection-Site Paradigm: A Retrospective Chart Review Study.
Aims: OnabotulinumtoxinA (onabotA) is an approved treatment for overactive bladder (OAB). This chart review study aims to determine treatment persistence in patients receiving onabotA (100 U) via a reduced injection-site paradigm distributed across ≤ 3 injection sites.
Methods: This study was a single site, noninterventional, retrospective chart review evaluating adult female OAB patients refractory to behavioral modification and pharmacotherapy before receiving ≥ 1 treatment with onabotA (100 U) via 1-3 injections between July 2017 and June 2021. Patients with neurologic OAB, predominance of stress incontinence, or who expired during the study were excluded. Baseline demographics, treatment patterns, treatment persistence, treatment intervals, lidocaine pretreatment, patient-reported treatment response, and adverse urological events were documented and evaluated. Persistence was defined as the percent of patients receiving ≥ 3 treatments during the study period via three or fewer injections. Continuous variables were summarized with sample size, mean (standard deviation [SD]), and median (1st and 3rd quartiles); categorical variables were calculated as frequencies and percentages.
Results: Of the 90 patients included in this study, 55 (61.1%) were persistent to treatment with onabotA for OAB, completing 3 treatments by the end of the data collection period. Urinary tract infection (UTI) was reported after 18/370 (4.9%) treatments. Of 90 patients,15 (16.7%) reported UTI after any treatment, and none required clean intermittent catheterization.
Conclusion: When onabotA was administered via a reduced injection-site paradigm, 61.1% of patients were persistent to OAB treatment. Given the limited pool of patients included in this study and relatively low sample sizes at later timepoints, results may not be generalizable. No new safety signals were identified using the reduced injection-site paradigm.
Clinical trial registration: Due to the nature of this study, no clinical trial registration was required.
期刊介绍:
Neurourology and Urodynamics welcomes original scientific contributions from all parts of the world on topics related to urinary tract function, urinary and fecal continence and pelvic floor function.