PDF(Pubmed)
Abstract：
UNASSIGNED: Erectile Dysfunction (ED) is a common challenge post Radical Prostatectomy (RALP), affecting men\'s sexual health after undergoing definitive cancer therapy. Despite employing nerve-sparing techniques, ED remains a prevalent issue in this population. Studies indicate that approximately 70%-85% of men experience varying degrees of ED following RALP. The existing treatment landscape for post-RALP-ED presents limitations, and a discernible knowledge gap persists. To address this, our study aims to investigate the efficacy of Shockwave Therapy (SWT) as a potential intervention for managing ED after RALP.
UNASSIGNED: This prospective, randomized, sham-controlled clinical trial aims to recruit 189 eligible patients post-RP and assess the effects of SWT. Comprehensive screening, including medical history, physical examinations, and biochemical evaluations, will be conducted to confirm eligibility. The intervention involves utilizing a device to administer focal shockwaves targeted at cavernosal tissue. Safety measures include continuous monitoring for adverse events and rigorous reporting protocols. The primary endpoint assesses changes in participants\' ability to engage in penetrative intercourse from baseline to study completion, while secondary endpoints encompass various measures of erectile function, including questionnaire-based assessments, ultrasound parameters, and clinical outcomes.
UNASSIGNED: Statistical analysis, encompassing ANOVA for continuous variables and Fisher\'s exact test for categorical ones, will evaluate demographic characteristics, baseline data, and primary as well as secondary outcomes for statistical significance. Detailed analysis of trends, subgroup comparisons, and treatment effects will provide a comprehensive understanding of the impact of SWT on post-RP ED.
UNASSIGNED: This study protocol represents a rigorous investigation into the potential therapeutic role of SWT in managing post-RP ED. The outcomes from this study aim to contribute valuable insights into the efficacy, safety, and potential improvements in erectile function following SWT, providing significant guidance for future interventions aimed at addressing this challenging condition affecting men\'s health and quality of life.
UNASSIGNED: This prospective, randomized, sham-controlled clinical trial aims to recruit 189 eligible patients post-RP and assess the effects of SWT. Comprehensive screening, including medical history, physical examinations, and biochemical evaluations, will be conducted to confirm eligibility. The intervention involves utilizing a device to administer focal shockwaves targeted at cavernosal tissue. Safety measures include continuous monitoring for adverse events and rigorous reporting protocols. The primary endpoint assesses changes in participants\' ability to engage in penetrative intercourse from baseline to study completion, while secondary endpoints encompass various measures of erectile function, including questionnaire-based assessments, ultrasound parameters, and clinical outcomes.
UNASSIGNED: Statistical analysis, encompassing ANOVA for continuous variables and Fisher\'s exact test for categorical ones, will evaluate demographic characteristics, baseline data, and primary as well as secondary outcomes for statistical significance. Detailed analysis of trends, subgroup comparisons, and treatment effects will provide a comprehensive understanding of the impact of SWT on post-RP ED.
UNASSIGNED: This study protocol represents a rigorous investigation into the potential therapeutic role of SWT in managing post-RP ED. The outcomes from this study aim to contribute valuable insights into the efficacy, safety, and potential improvements in erectile function following SWT, providing significant guidance for future interventions aimed at addressing this challenging condition affecting men\'s health and quality of life.
摘要：
■勃起功能障碍（ED）是前列腺癌根治术（RALP）后的常见挑战，在接受明确的癌症治疗后影响男性的性健康。尽管采用了保留神经的技术，ED仍然是这个人群中普遍存在的问题。研究表明，大约70％-85％的男性在RALP后经历不同程度的ED。后RALP-ED的现有处理景观存在局限性，明显的知识差距仍然存在。为了解决这个问题，本研究旨在探讨冲击波疗法(SWT)作为治疗RALP后ED的潜在干预措施的疗效.
■这个前景，随机化，假对照临床试验旨在招募189名RP后合格患者,并评估SWT的效果.全面筛选,包括病史,体检,和生化评估，将进行确认资格。介入涉及利用装置来施予靶向海绵体组织的局灶性冲击波。安全措施包括持续监测不良事件和严格的报告方案。主要终点评估参与者从基线到完成研究的渗透性交能力的变化，而次要终点包括勃起功能的各种测量，包括基于问卷的评估，超声参数,和临床结果。
■统计分析，包括连续变量的方差分析和分类变量的Fisher精确检验，将评估人口统计特征，基线数据，以及主要和次要结果的统计学意义。详细分析趋势，亚组比较，和治疗效果将全面了解SWT对RP后ED的影响。
■该研究方案代表了对SWT在RP后ED管理中的潜在治疗作用的严格调查。这项研究的结果旨在为疗效提供有价值的见解，安全,以及SWT后勃起功能的潜在改善，为解决这一影响男性健康和生活质量的挑战性疾病的未来干预措施提供重要指导。
■这个前景，随机化，假对照临床试验旨在招募189名RP后合格患者,并评估SWT的效果.全面筛选,包括病史,体检,和生化评估，将进行确认资格。介入涉及利用装置来施予靶向海绵体组织的局灶性冲击波。安全措施包括持续监测不良事件和严格的报告方案。主要终点评估参与者从基线到完成研究的渗透性交能力的变化，而次要终点包括勃起功能的各种测量，包括基于问卷的评估，超声参数,和临床结果。
■统计分析，包括连续变量的方差分析和分类变量的Fisher精确检验，将评估人口统计特征，基线数据，以及主要和次要结果的统计学意义。详细分析趋势，亚组比较，和治疗效果将全面了解SWT对RP后ED的影响。
■该研究方案代表了对SWT在RP后ED管理中的潜在治疗作用的严格调查。这项研究的结果旨在为疗效提供有价值的见解，安全,以及SWT后勃起功能的潜在改善，为解决这一影响男性健康和生活质量的挑战性疾病的未来干预措施提供重要指导。
