External Anal Sphincter Fatigability (EASF)

External Anal Sphincter Fatigability, an Electromyographic and Manometric Study

External anal sphincter is a Skeletal muscle under voluntary control. As described in previous studies, it is mainly composed of type 1 fibers. Fatigability is a concept which has been studied and described many times in skeletal limbs muscles. Two types of fatigue are described, peripheral of central fatigue. Fatigue can been physiologic but also pathologic (due to an affection of the muscle, the peripheral nervous system or the central nervous system). Many tools have been used to measure muscle fatigability (direct strength measure on isometric contraction, electromyography, echography, oxymetry...).

Besides many fatiguing methods have been developed for every each muscle depending on its histological structure.

Anal sphincter fatigability has already been described in few manometric studies with particularly 2 measures: Fatigue Rate and Fatigue Rate Index. Moreover, no fatiguing protocol has been standardized to study it.

The primary aim of this study is to define a fatiguing protocol for external anal sphincter in order to study it in further studies. Secondary aims are to assess Electromyography as a tool for measuring this fatigability and finally to assess the link between anal sphincter fatigability and symptoms reported by patients.

Patients over 18 years old, consulting for an Anorectal Manometry with a voluntary command on the external anal sphincter are included.

History and treatment, height, weight, sex, age, Fatigue impact scale, digestive symptoms with Neurologic Bowel Disorders score and Wexner scale, urinary tract symptoms with Urinary Symptom Profile (USP) score and electromyography (Root Mean Square (RMS) and Mean Power Frequency (MPF)) and manometric data (contraction peak, fatigue rate, fatigue rate index) were recorded.

The fatiguing protocol consists in 10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting. A training contraction is made before the fatiguing protocol. At the end of the protocol, patients undergo a classical anorectal manometry.

Primary outcome is the difference on root mean square in electromyography between the first and the last fatiguing contraction.

Secondary outcomes were mean power frequency and manometric data (i.e. Fatigue Rate index (FRI), Fatigue Rate (FR), contraction Peak)

Influence of age, sex, symptoms, pathologies, weight on fatigability will be studied in a second analysis

Study Overview

• Status: Completed
• Conditions: External Anal Sphincter Fatigability
• Intervention / Treatment: Other: Fatiguing contractions

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • department of Neuro-Urology, Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients over 18 years old presenting for anorectal manometry examination in order to explore anorectal disorders between 01/08/2019 and 31/10/2019 with a voluntary command on external anal sphincter contraction

Description

Inclusion Criteria:

• over 18 years old
• voluntary command on external anal sphincter contraction during physical examination
• Anorectal disorders

Exclusion Criteria:

• inability to understand simple orders

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing fatiguing protocol; patient consulting for anorectal manometry in order to explore anorectal disorders with a voluntary command on external anal sphincter	Other: Fatiguing contractions; 10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation in electromyographic muscle response 1	Difference between first and last fatiguing contractions on surface electromyographic Root Mean Square (RMS)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation of electromyographic muscle response 2	Difference between first and last fatiguing contractions on surface electromyographic Mean Power Frequency (MPF)	1 day
variation of external anal sphincter contractions with manometry 1	Difference between first and last contractions on manometrical Fatigue rate	1 day
variation of external anal sphincter contractions with manometry 2	Difference between first and last contractions on manometrical Fatigue rate Index	1 day
variation of external anal sphincter contractions with manometry 3	Difference between first and last contractions on manometrical Peak of Contraction	1 day

Collaborators and Investigators

• Sponsor: Gérard Amarenco
• Investigators: Principal Investigator: Gérard Amarenco, Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): November 2, 2019

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Electromyography; Muscle fatigue; Anorectal Manometry; Anal Canal; External Anal Sphincter
• Other Study ID Numbers: GRC--01 GREEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No