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临床试验/NCT05893394
NCT05893394招募中不适用

Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
62
试验地点
1
主要终点
Correlation between Core stability functionality and Urinary Incontinence.

研究概览

简要总结

The study aims at investigating the possible correlation between core stability muscles and urinary incontinence following Robot-Assisted Laparoscopic Prostatectomy.

Sixty-two patients who are candidates for Robot-Assisted Laparoscopic Prostatectomy will be enrolled. All participants will be asked to be evaluated in their core stability functionality 30-40 days before Robot-Assisted Laparoscopic Prostatectomy intervention. The core stability functionality result will be correlated with the urinary incontinence 45-50 days after intervention.

详细描述

The study aims at investigating the correlation between core stability muscles and urinary incontinence following Robot-Assisted Laparoscopic Prostatectomy.

All sixty-two participants will be asked to be evaluated in their core stability functionality 30-40 days before Robot-Assisted Laparoscopic Prostatectomy intervention. Core stability functionality will be evaluated through the Loumajoki Battery of tests, composed of 10 simple items in which the patients have to maintain core stability. In addition a Quality of Life questionnaire (WHO Quality of Life-BREF) will be administered. The core stability functionality result will be correlated with urinary incontinence measured by the 24h PAD test 45-50 days after intervention. At this point core stability will be evaluated again as done before.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者
否

入选标准

  • •Patient who are candidates for Robot-Assisted Laparoscopic Prostatectomy
  • •Objectivity of core muscles recruitment through the Loumajoki Battery

排除标准

  • •Pre-surgery incontinence
  • •Pre-intervention radiotherapy treatment
  • •Previous urogenital surgery
  • •Concomitant presence of neurological, internal medicine or musculoskeletal system pathologies that may affect functional or motor recovery
  • •Subjects with cognitive deficits and/or psychiatric disorders
  • •Lumbar stabilization or abdominal interventions
  • •Acute low back pain

结局指标

主要结局

Correlation between Core stability functionality and Urinary Incontinence.

时间窗: Core stability evaluated 30-40 days before surgery. Urinary incontinence evaluated 45-50 days after surgery

To evaluate any correlation between Core stability functionality measured with Loumajoki Battery and Urinary Incontinence measured with 24h PAD test.

次要结局

  • Correlation between Core stability functionality and Quality of Life.(Core stability evaluated 30-40 days before surgery. Quality of Life evaluated 30-40 days before surgery)
  • Variation between Core stability functionality at base line and at follow-up.(Core stability evaluated 30-40 days before surgery and 45-50 days after surgery)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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