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

NCT04409054 | Completed

• 1 other identifier: GREEN GRC_01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorectal Disorder

Keywords

Anal Canal; Reflex; Anorectal Manometry; Fecal incontinence; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in curve slope between each volume of distension at cough

  1 day

• Difference in curve slope between each volume of distension at Valsalva type effort.

  1 day

Study Arms (1)

Patients undergoing the cough and Valsalva protocol

Patients over 18 years old, consulting in neuro urology departement, undergoing ano rectal manometry in order to explore ano rectal disorders

Other: Cough and Valsalva effort

Interventions

Cough and Valsalva effort OTHER

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

Patients undergoing the cough and Valsalva protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over eighteen years old consulting in the neuro urology departement for ano rectal disorders, undergoing ano rectal manometry examination

You may qualify if:

• Over 18 years old
• Ano rectal disorders

You may not qualify if:

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

Sponsors & Collaborators

• Gérard Amarenco: lead

Study Sites (1)

Department of neuro-urology, hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Rectal Diseases; Fecal Incontinence

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gérard Amarenco, PhD

  Sorbonne Université, GRC 001, GREEN, AP-HP,Hôpital Tenon, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Neuro-Urology department, Tenon Hospital

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: February 17, 2020
• Primary Completion: June 2, 2020
• Study Completion: June 30, 2020
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)