Electromyographic (EMG) and Mechanomyographic (MMG) Comparison

Stress Urinary Incontinence Clinical Trial

— EMG-MMG  

Official title:

Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942370
• Other study ID #: DCIC 0904
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: September 14, 2016
• Start date: July 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• More or equal than 18 years old

• Patient affiliated to social security or similarly regime

• Healthy volunteer

• BMI less than 30

Exclusion Criteria:

• Pregnant women and lactating mothers

• Ward of court or under guardianship

• Adult unable to express their consent or person under legal protection

• Person deprived of freedom by judicial or administrative decision

• Person hospitalized without their consent

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• non invasive mechanomyographic device based on a 3 axes accelerometer
This biomedical research consists specifically in the simultaneous acquisition of: EMG and MMG Signals of rectus abdominis of the abdomen, Respiratory flow, An electrocardiogram (ECG). These acquisitions will be conducted on 16 healthy volunteers according to a standardized protocol, at rest and during voluntary cough and various physical exercises often resulting in urinary leakage in the incontinent person.

Locations

Country	Name	City	State
France	Clinical Investigation Center - INSERM - University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort		2 hours	Yes
Secondary	Lower and upper spectral band frequencies values for which the majority of the MMG signal is present, thresholds for detection of rectus abdominis contraction by mechanical myography		2 hours	Yes

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