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临床试验/NCT03714984
NCT03714984已完成不适用

The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence in Patients Underwent Robotic Prostatectomy. A Randomized Clinical Trial

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Change in self-reported urinary continence

研究概览

简要总结

Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of pelvic floor rehabilitation in this population. Our study aims to assesses the efficacy of preoperative educational method in urinary incontinence after robotic prostatectomy.

详细描述

Prostate cancer is the most common type of cancer between male population, with 161,300 new cases a year in the USA and an incidence of 10% in Italy. Since many years surgery is the treatment of choice, both at an early stage and in advanced cases, but involves side effects. From the post-operative problem presents in literature, urinary incontinence (UI) is the most common of long-term sequelae and significantly affects the quality of life and the psychological aspect in the post-surgical period. The incidence of UI after prostatectomy surgery varies between 0.8% and 87% in the first 3 and 6 months and between 5% and 44.5% after 1 year. This variability depends on the UI definition and the type of measurement used, which are not homogeneous among the various studies in the literature. Evaluations that are not objective make it difficult to compare the results obtained, thus creating discrepancies.

To date, robotic prostatectomy is becoming the gold standard for its recognized greater accuracy when compared with the open surgery and laparoscopic procedure, with a reduced learning curve for operators and giving better post-surgical results. Progress technological aspects, such as the three-dimensional vision of the operative field, the macroscopic magnification and better image resolution, have made the robotic procedure a less invasive surgery with better functional outcomes. Despite these factors, UI is still present and in the majority of cases management is not completely evidence based. Moreover there is not yet a definite consensus regarding the predictive factors (age, disease stage, body weight, prostate volume and other comorbidities) in the incidence of the UI.

When patients presents UI diagnoses, the conservative intervention through the pelvic floor rehabilitation is recommended in an attempt to reduce the impact of this complication. Muscle strengthening and pelvic floor awareness after surgery are used for years in clinical practice with results widely documented in the literature, but their effectiveness in the pre-operative period, especially if after robotic surgery, has not yet been sufficiently studied. Currently, there are discrepant results mainly due to the type of rehabilitative methodology applied and the time of beginning the preoperative treatment. Our study tries to evaluate, through an objective and reproducible measurement, the efficacy of a preoperative educational method in urinary incontinence after robotic prostatectomy.

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
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Signed informed consent form
  • Age >= 40 <= 70 years old
  • Body mass Index <= 27
  • Indication of robotic prostate surgery
  • Tumor with clinical stage T1 and T
  • Extracapsular Extension Score <= 3, measured with magnetic resonance before surgery.

排除标准

  • Pathologic T3 tumor with radiotherapy indication
  • Previous prostate surgery
  • Previous urinary incontinence.
  • Metabolic disorder
  • Central or peripheral neurologic disorders
  • Inability to understand informed consent or to carry out the rehabilitation protocol autonomously.

结局指标

主要结局

Change in self-reported urinary continence

时间窗: 1,3,6 months and 1 year after surgery

Continence (completely dry patient) will be defined as the sum of no urinary leakage reported by the patient in his bladder diary

次要结局

  • Quality of life instrument(1,3,6 months and 1 year after surgery)
  • Assesment of the urinary status with the International Consultation on Incontinence (ICIQ) Questionnaire.(1,3,6 months and 1 year after surgery)
  • The degree of urinary incontinence.(1,3,6 months and 1 year after surgery)
  • Assesment of the individual resilience with the resilience scale for adults (RSA).(1,3,6 months and 1 year after surgery)
  • Assesment of the post traumatic distress using the Impact of event Scale (IES).(1,3,6 months and 1 year after surgery)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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