External Anal Sphincter FatigabilityEASFNCT04067453
External Anal Sphincter Fatigability
An observational study of External Anal Sphincter Fatigability, run by Gérard Amarenco at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- External Anal Sphincter Fatigability
- What is being tested?
- Fatiguing contractions
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 2 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- over 18 years old
- voluntary command on external anal sphincter contraction during physical examination
- Anorectal disorders
Who cannot join
- inability to understand simple orders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- External Anal Sphincter Fatigability
- Being tested
- Fatiguing contractions
- Keywords
- Anal Canal, External Anal Sphincter, Muscle fatigue, Electromyography, Anorectal Manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatiguing contractionsOther
10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing fatiguing protocol | patient consulting for anorectal manometry in order to explore anorectal disorders with a voluntary command on external anal sphincter Receives: Other: Fatiguing contractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in electromyographic muscle response 1
Difference between first and last fatiguing contractions on surface electromyographic Root Mean Square (RMS)
Measured: 1 day
Secondary outcomes (4)
variation of electromyographic muscle response 2
Difference between first and last fatiguing contractions on surface electromyographic Mean Power Frequency (MPF)
Measured: 1 day
variation of external anal sphincter contractions with manometry 1
Difference between first and last contractions on manometrical Fatigue rate
Measured: 1 day
variation of external anal sphincter contractions with manometry 2
Difference between first and last contractions on manometrical Fatigue rate Index
Measured: 1 day
variation of external anal sphincter contractions with manometry 3
Difference between first and last contractions on manometrical Peak of Contraction
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Aug 2019
- Primary completion31 Oct 2019
- Study completion2 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Anal Sphincter FatigabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérard Amarenco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, Principal investigator, Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067453
- Sponsor's protocol ID
- GRC--01 GREEN
- Acronym
- EASF
- Status last verified
- Nov 2019
- First submitted
- 12 Aug 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Anal Sphincter Fatigability, an Electromyographic and Manometric Study
- ClinicalTrials.gov ID
- NCT04067453
- Acronym / sponsor ID
- EASF / GRC--01 GREEN
- Conditions
- External Anal Sphincter Fatigability
- Keywords
- Anal Canal, External Anal Sphincter, Muscle fatigue, Electromyography, Anorectal Manometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gérard AmarencoUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 2 Nov 2019 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing fatiguing protocol | – | Other: Fatiguing contractionspatient consulting for anorectal manometry in order to explore anorectal disorders with a voluntary command on external anal sphincter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- over 18 years old
- voluntary command on external anal sphincter contraction during physical examination
- Anorectal disorders
Key exclusion criteria (1 listed)
- inability to understand simple orders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatiguing contractions10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting. | Other | Patients undergoing fatiguing protocol |
Primary outcome
Variation in electromyographic muscle response 1
Time frame: 1 day
Difference between first and last fatiguing contractions on surface electromyographic Root Mean Square (RMS)
4 secondary outcomes
variation of electromyographic muscle response 2
Time frame: 1 day
variation of external anal sphincter contractions with manometry 1
Time frame: 1 day
variation of external anal sphincter contractions with manometry 2
Time frame: 1 day
variation of external anal sphincter contractions with manometry 3
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérard Amarenco principal investigator
Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of External Anal Sphincter Fatigability, run by Gérard Amarenco at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in electromyographic muscle response 1 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.