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

Anorectal Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409054
• Other study ID #: GREEN GRC_01
• Status: Completed
• Start date: February 17, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2022
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

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 : empty rectum, volume for first sensation of filling, volume for desire to defecate and maximal tolerable volume. 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 the differences in curve slope between each volume of distension at Valsalva type effort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Ano rectal disorders

Exclusion Criteria:

• Inability to understand simple orders

• Anal hypotonia

• Peripheral neurological disorder

• Anal incontinence

Related Conditions & MeSH terms

• Anorectal Disorder
• Rectal Diseases

Intervention

Other:
• Cough and Valsalva effort
Three increasingly cough effort and three Valsalva type effort at four different volumes of rectal distension (empty rectum, volume for a first sensation of filling, volume for desire to defecate and maximal tolerable volume) while recording the external anal sphincter activity

Locations

Country	Name	City	State
France	Department of neuro-urology, hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Gérard Amarenco

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in curve slope between empty rectum and maximal tolerable volume at cough	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.	1 day
Secondary	Difference in curve slope between each volume of distension at cough	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.	1 day
Secondary	Difference in curve slope between each volume of distension at Valsalva type effort.	The area under the curve of EAS response to stress is recorded three times (at each Valsalva type 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.	1 day