Clinical trial NCT04067453: External Anal Sphincter Fatigability
Official title: External Anal Sphincter Fatigability, an Electromyographic and Manometric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: External Anal Sphincter Fatigability
Keywords: Anal Canal
External Anal Sphincter
Muscle fatigue
Electromyography
Anorectal Manometry
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Variation in electromyographic muscle response 1
timeFrame: 1 day
Secondary outcomes:
measure: variation of electromyographic muscle response 2
timeFrame: 1 day
measure: variation of external anal sphincter contractions with manometry 1
timeFrame: 1 day
measure: variation of external anal sphincter contractions with manometry 2
timeFrame: 1 day
measure: variation of external anal sphincter contractions with manometry 3
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: department of Neuro-Urology, Hôpital Tenon
Study officials:
affiliation: Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
name: Gérard Amarenco
role: PRINCIPAL_INVESTIGATOR
References: