External Anal Sphincter Fatigability (EASF)
|ClinicalTrials.gov Identifier: NCT04067453|
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : November 29, 2019
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
|Condition or disease||Intervention/treatment|
|External Anal Sphincter Fatigability||Other: Fatiguing contractions|
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||External Anal Sphincter Fatigability, an Electromyographic and Manometric Study|
|Actual Study Start Date :||August 1, 2019|
|Actual Primary Completion Date :||October 31, 2019|
|Actual Study Completion Date :||November 2, 2019|
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.
- Variation in electromyographic muscle response 1 [ Time Frame: 1 day ]Difference between first and last fatiguing contractions on surface electromyographic Root Mean Square (RMS)
- variation of electromyographic muscle response 2 [ Time Frame: 1 day ]Difference between first and last fatiguing contractions on surface electromyographic Mean Power Frequency (MPF)
- variation of external anal sphincter contractions with manometry 1 [ Time Frame: 1 day ]Difference between first and last contractions on manometrical Fatigue rate
- variation of external anal sphincter contractions with manometry 2 [ Time Frame: 1 day ]Difference between first and last contractions on manometrical Fatigue rate Index
- variation of external anal sphincter contractions with manometry 3 [ Time Frame: 1 day ]Difference between first and last contractions on manometrical Peak of Contraction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067453
|department of Neuro-Urology, Hôpital Tenon|
|Paris, France, 75020|
|Principal Investigator:||Gérard Amarenco||Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France|