Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

• Conditions: Pelvic Floor Dyssynergia

• Registration Number: NCT01590927
• Lead Sponsor: Moser, Helene

Brief 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. 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 Timeline

• Study First Submitted: 2012-04-27
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-02
• Last Update Submitted: 2012-05-02
• Study First Posted: 2012-05-03
• Last Update Posted: 2012-05-03
• Study Start: 2012-08
• Primary Completion: 2013-02
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• women
• aged between 18 and 35 years
• anamnestically healthy
• nulliparous and
• a BMI between 18 and 30

Exclusion Criteria

• latex and nickel allergy
• anamnestically current pregnancy
• menstruation
• urogenital operations
• anal operations
• vaginal infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR	one year	the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR

Secondary Outcome Measures

Name	Time	Method
EMG	one year	EMG will measure the contraction of the plevic floor

Trial Locations

Locations (1)

Inselspital; 🇨🇭 Bern, Switzerland