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Completed

NCT Number: NCT04067453

External Anal Sphincter Fatigability

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

department of Neuro-Urology, Hôpital Tenon

Paris, 75020, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fatiguing contractions

Other

10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting.

Primary outcomes

  1. Variation in electromyographic muscle response 1

    Time frame: 1 day

    Difference between first and last fatiguing contractions on surface electromyographic Root Mean Square (RMS)

Secondary outcomes

  1. variation of electromyographic muscle response 2

    Time frame: 1 day

    Difference between first and last fatiguing contractions on surface electromyographic Mean Power Frequency (MPF)

  2. variation of external anal sphincter contractions with manometry 1

    Time frame: 1 day

    Difference between first and last contractions on manometrical Fatigue rate

  3. variation of external anal sphincter contractions with manometry 2

    Time frame: 1 day

    Difference between first and last contractions on manometrical Fatigue rate Index

  4. variation of external anal sphincter contractions with manometry 3

    Time frame: 1 day

    Difference between first and last contractions on manometrical Peak of Contraction

Sponsors and collaborators

Lead sponsor

Gérard Amarenco

Other

Registry information

Official study title

External Anal Sphincter Fatigability, an Electromyographic and Manometric Study

Acronym: EASF

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.