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临床试验/NCT02558946
NCT02558946进行中(未招募)不适用

Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men with Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy

Indiana University2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2015年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
113
试验地点
2
主要终点
• Comparison of post-op EPIC scores in the two study groups

研究概览

简要总结

The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy.

详细描述

Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery.

In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients scheduling to undergo robot-assisted radical prostatectomy
  • Patients willing and able to complete the EPIC questionnaire in its entirety
  • Ability to provide informed consent

排除标准

  • Previous prostate surgery
  • Radiation treatment
  • History of incontinence defined as any pad use for urinary leakage in the past 6 months

结局指标

主要结局

• Comparison of post-op EPIC scores in the two study groups

时间窗: 4 to 8 weeks post-op

次要结局

  • Return to continence following surgery(Up to 12 months post-op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronald Boris

Associate Professor, Urology

Indiana University

研究点 (2)

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