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临床试验/NCT04409054
NCT04409054已完成不适用

The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension

Gérard Amarenco1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年2月17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
10
试验地点
1
主要终点
Difference in curve slope between empty rectum and maximal tolerable volume at cough

研究概览

简要总结

The term Guarding Reflex refers to a progressive, involuntary increase in the external urethral sphincter activity during bladder filling.This is a mechanism of continence, preventing from unwanted urine leakage in situation of stress.

Anal continence is essential, and any impairment of this function can have a severe impact on quality of life. Anal continence at rest is mainly insured by the tone of the internal anal sphincter. The external anal sphincter activity during gradually rectal filling is continuous and varies according to the volume of rectal distension.

During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the rectum. Increased intra-abdominal pressure during an expiratory against resistance effort proportionally increases the response of the external anal sphincter. The reflex contraction of the EAS is an active mechanism under spinal control, and result in a stronger contraction than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and provides part of the continence in situation of stress.

The main purpose of this study is to research a correlation between the ano rectal distension volume and the external anal sphincter response to a stress.

Patient over eighteen years old, consulting for anorectal manometry examination in order to explore anorectal disorders are included.

Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the curve for electromyography activity of the EAS and intercostal muscles during cough with a Valsalva effort are recorded. Slope curve representing the EAS response to stress according to the intercostal activity reflecting cough (intensity response curve) effort are calculated.

The protocol consists in distending the rectum at four different volumes. For each volume, the patient is asked to cough three times gradually, and perform a Valsalva effort three times gradually.

Primary outcome is the difference in curve slope (intensity response curves) between empty rectum and maximal tolerable volume at cough Secondary outcomes are the differences in curve slope between each volume of distension at cough, and Valsalva type effort.

详细描述

The term Guarding Reflex refers to a progressive, involuntary increase in the external urethral sphincter (EUS) activity during bladder filling. Situations increasing intra-abdominal pressure, as cough, or Valsalva effort, increases this EUS activity. This is a mechanism of continence, preventing from unwanted urine leakage in situation of stress.

Anal continence is essential, and any impairment of this function can have a severe impact on quality of life. The anal canal is composed of the internal anal sphincter (IAS) at the top, with smooth musculature and the external anal sphincter (EAS) at the bottom, with striated musculature. The activity of the external anal sphincter is controlled by sympathetic and somatic innervation. Anal continence at rest is mainly insured by the tone of the internal anal sphincter. The external anal sphincter activity during gradually rectal filling is continuous and varies according to the volume of rectal distension.

During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the rectum. Increased intra-abdominal pressure during an expiratory against resistance effort proportionally increases the response of the external anal sphincter. The reflex contraction of the EAS is an active mechanism under spinal control, and result in a stronger contraction than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and provides part of the continence in situation of stress.

Previous studies focused on the search of segmental or supra segmental control of this reflex. Few studies have examined factors affecting the modulation of the EAS response during stress.

The main purpose of this study is to research a correlation between the ano rectal distension volume and the external anal sphincter response to a stress.

研究设计

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

入排标准

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

入选标准

  • •Over 18 years old
  • •Ano rectal disorders

排除标准

  • •Inability to understand simple orders
  • •Anal hypotonia
  • •Peripheral neurological disorder
  • •Anal incontinence

结局指标

主要结局

Difference in curve slope between empty rectum and maximal tolerable volume at cough

时间窗: 1 day

The area under the curve of EAS response to stress is recorded three times (at each cough effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.

次要结局

  • Difference in curve slope between each volume of distension at Valsalva type effort.(1 day)
  • Difference in curve slope between each volume of distension at cough(1 day)

研究者

发起方
Gérard Amarenco
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gérard Amarenco

Head of Neuro-Urology department, Tenon Hospital

Pierre and Marie Curie University

研究点 (1)

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