Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

External Anal Sphincter Fatigability (EASF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067453
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Gérard Amarenco, Pierre and Marie Curie University

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


Condition or disease Intervention/treatment
External Anal Sphincter Fatigability Other: Fatiguing contractions

Layout table for study information
Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067453


Locations
Layout table for location information
France
department of Neuro-Urology, Hôpital Tenon
Paris, France, 75020
Sponsors and Collaborators
Gérard Amarenco
Investigators
Layout table for investigator information
Principal Investigator: Gérard Amarenco Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
Layout table for additonal information
Responsible Party: Gérard Amarenco, Head of Neuro-Urology department, Tenon Hospital, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT04067453    
Other Study ID Numbers: GRC--01 GREEN
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérard Amarenco, Pierre and Marie Curie University:
Anal Canal
External Anal Sphincter
Muscle fatigue
Electromyography
Anorectal Manometry