Stress Urinary IncontinenceEMG-MMGNCT00942370
Electromyographic (EMG) and Mechanomyographic (MMG) Comparison
An observational study of Stress Urinary Incontinence, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- non invasive mechanomyographic device based on a 3 axes accelerometer
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Jul 2009
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- More or equal than 18 years old
- Patient affiliated to social security or similarly regime
- Healthy volunteer
- BMI less than 30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Investigation Center - INSERM - University Hospital of Grenoble
Grenoble
About this study
Official title: Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- non invasive mechanomyographic device based on a 3 axes accelerometer
- Keywords
- mechanography, electromyography, effort cough
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive mechanomyographic device based on a 3 axes accelerometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| accelerometric device | Not described Receives: Device: non invasive mechanomyographic device based on a 3 axes accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort
Measured: 2 hours
Secondary outcomes (1)
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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Moreau-Gaudry, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942370
- Sponsor's protocol ID
- DCIC 0904
- Acronym
- EMG-MMG
- Status last verified
- Sep 2016
- First submitted
- 2 Jul 2009
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis
- ClinicalTrials.gov ID
- NCT00942370
- Acronym / sponsor ID
- EMG-MMG / DCIC 0904
- Conditions
- Stress Urinary Incontinence
- Keywords
- mechanography, electromyography, effort cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Jul 2009 (estimated)
- 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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| accelerometric device | – | Device: non invasive mechanomyographic device based on a 3 axes accelerometer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- More or equal than 18 years old
- Patient affiliated to social security or similarly regime
- Healthy volunteer
- BMI less than 30
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| non invasive mechanomyographic device based on a 3 axes accelerometerThis 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. | Device | accelerometric device |
Primary outcome
Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort
Time frame: 2 hours
1 secondary outcome
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
Time frame: 2 hours
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 15 Sep 2016.
- Related InfoLink provided by the sponsor.
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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.
Alexandre Moreau-Gaudry, MD, PhD principal investigator
University Hospital, Grenoble
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 Stress Urinary Incontinence, run by University Hospital, Grenoble 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 4 inclusion and 5 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 15 Sep 2016. 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?
Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort (time frame: 2 hours). 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 15 Sep 2016.