Pelvic Floor DyssynergiaNCT01590927
Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study
An observational study of Pelvic Floor Dyssynergia, run by Moser, Helene at 1 site in Switzerland.
Trial summary
Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, \& Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dyssynergia
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to May 2013
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy women, students of the University of Applied Sciences Health
Who may be able to join
- women
- aged between 18 and 35 years
- anamnestically healthy
- nulliparous and
- a BMI between 18 and 30
Who cannot join
- latex and nickel allergy
- anamnestically current pregnancy
- menstruation
- urogenital operations
- anal operations
- vaginal infections
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital
Bern, Canton of Bern, 3010
Helene Moser, MSc in study, 0041787752118, helmos69@gmail.com
About this study
Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, \& Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be used in measuring functional movements. In this Master thesis the hypothesis is to show a good reliability by trampoline jumping (physical activity).
Read the detailed description
There will be two measurements. One measurement of MVIC and quick flicks will be done in a standing and supine position with 3 repetitions. The TrakSTARTM, Ultrasound, surface EMG and Accelerometer will measure the PFM movements and activation simultaneously. The Ultrasound is measured from one tester (to guaranty a high intratester reliability) (Sherburn et al., 2005).
TrakSTARTM, surface EMG and Accelerometer will measure 3 Trampoline jumps. The measurements will be done once during one hour. The women will insert the vaginal probe by themselves and stay dressed during the measurement procedure. The measurements will be done in a standardized way. All the arrangements are made to ensure the hygiene requirements.
- Conditions
- Pelvic Floor Dyssynergia
- Keywords
- pelvic floor, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 20 healthy women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR
the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR
Measured: one year
Secondary outcomes (1)
EMG
EMG will measure the contraction of the plevic floor
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DyssynergiaStudies 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
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moser, Helene
- Responsible party
- Principal investigator, Helene Moser, Moser, Helene
- Investigators
- Lorenz Radlinger, PhD, Study chair, Berner Fachhochschule Gesundheit, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590927
- Sponsor's protocol ID
- MScPTHM
- Status last verified
- May 2012
- First submitted
- 27 Apr 2012
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Peng Q, Jones RC, Constantinou CE. 2D Ultrasound image processing in identifying responses of urogenital structures to pelvic floor muscle activity. Ann Biomed Eng. 2006 Mar;34(3):477-93. doi: 10.1007/s10439-005-9059-3. Epub 2006 Feb 16.
PubMed 16496082Sherburn M, Murphy CA, Carroll S, Allen TJ, Galea MP. Investigation of transabdominal real-time ultrasound to visualise the muscles of the pelvic floor. Aust J Physiother. 2005;51(3):167-70. doi: 10.1016/s0004-9514(05)70023-4.
PubMed 16137242
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study
- ClinicalTrials.gov ID
- NCT01590927
- Acronym / sponsor ID
- MScPTHM
- Conditions
- Pelvic Floor Dyssynergia
- Keywords
- pelvic floor, ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Moser, Helene
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 3 May 2012 (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.
Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, \& Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be used in measuring functional movements. In this Master thesis the hypothesis is to show a good reliability by trampoline jumping (physical activity).
Detailed description
There will be two measurements. One measurement of MVIC and quick flicks will be done in a standing and supine position with 3 repetitions. The TrakSTARTM, Ultrasound, surface EMG and Accelerometer will measure the PFM movements and activation simultaneously. The Ultrasound is measured from one tester (to guaranty a high intratester reliability) (Sherburn et al., 2005).
TrakSTARTM, surface EMG and Accelerometer will measure 3 Trampoline jumps. The measurements will be done once during one hour. The women will insert the vaginal probe by themselves and stay dressed during the measurement procedure. The measurements will be done in a standardized way. All the arrangements are made to ensure the hygiene requirements.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 healthy women | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy women, students of the University of Applied Sciences Health
Key inclusion criteria (5 listed)
- women
- aged between 18 and 35 years
- anamnestically healthy
- nulliparous and
- a BMI between 18 and 30
Key exclusion criteria (6 listed)
- latex and nickel allergy
- anamnestically current pregnancy
- menstruation
- urogenital operations
- anal operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR
Time frame: one year
the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR
1 secondary outcome
EMG
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Background: PubMed 16496082Peng Q, Jones RC, Constantinou CE. 2D Ultrasound image processing in identifying responses of urogenital structures to pelvic floor muscle activity. Ann Biomed Eng. 2006 Mar;34(3):477-93. doi: 10.1007/s10439-005-9059-3. Epub 2006 Feb 16.
- Background: PubMed 16137242Sherburn M, Murphy CA, Carroll S, Allen TJ, Galea MP. Investigation of transabdominal real-time ultrasound to visualise the muscles of the pelvic floor. Aust J Physiother. 2005;51(3):167-70. doi: 10.1016/s0004-9514(05)70023-4.
Related trials for Pelvic Floor Dyssynergia
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Not yet recruitingObservational study
Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students
Pelvic Floor Dyssynergia, Phonation Disorder
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.
Lorenz Radlinger, PhD study chair
Berner Fachhochschule Gesundheit, Bern, Switzerland
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 Pelvic Floor Dyssynergia, run by Moser, Helene at 1 site in Switzerland.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 May 2012. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helene Moser, Msc in study (0041787752118, helmos69@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590927, which also lists 2 linked publications.
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 3 May 2012.