Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2019-08-01
2019-11-02
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients undergoing fatiguing protocol
patient consulting for anorectal manometry in order to explore anorectal disorders with a voluntary command on external anal sphincter
Fatiguing contractions
10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting.
Interventions
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Fatiguing contractions
10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting.
Eligibility Criteria
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Inclusion Criteria
* voluntary command on external anal sphincter contraction during physical examination
* Anorectal disorders
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Gérard Amarenco
OTHER
Responsible Party
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Gérard Amarenco
Head of Neuro-Urology department, Tenon Hospital
Principal Investigators
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Gérard Amarenco
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
Locations
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department of Neuro-Urology, Hôpital Tenon
Paris, , France
Countries
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Other Identifiers
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GRC--01 GREEN
Identifier Type: -
Identifier Source: org_study_id