1. To explore the correlations among measures of PFM strength between using vaginal palpation quantified by modified Oxford Grading Scale and Levator ani testing and manometry in PHENIX instrument; 2. To determine the intra- and inter-rater reliability of PFM strength measured using manometry in PHENIX instrument.
This is a study using a randomized crossover blind method.All the volunteers are divided into 2 groups randomly. At the first time, a gynecological physician evaluates patient's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling patient her result, and record it on a unique paper other than in the Case Report Form. At the same day, patient will be tested by inspector A or B randomly twice with the PHENIX instrument.A 5 minutes' interval is needed between two tests in order to reduce the possibility of fatigue of pelvic floor muscles. The outcome is secretive to the patient as well. A second time evaluation is required in 3 days' later by a different inspector from the first time.(interrater and intrarater) All the data including strength of MOS and LAT, the outcomes by inspector A and B, cannot be collected together and told to the patient until she finished the whole process. Pelvic floor muscle training is not permitted during the evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
450
the PHENIX instrument was designed and produced for sensing muscle activity with surface electrodes, pressure probes and external captors,so it could test biological signals of pelvic floor muscle in human body.
vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, China
RECRUITINGMaximum vaginal contraction pressure
Maximum vaginal contraction pressure is evaluated by manometry
Time frame: 3 days
vaginal rest pressure
measure when no vaginal contraction by manometry
Time frame: 3 days
Pelvic floor muscle strength
The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation
Time frame: 1 day
Pelvic floor muscle strength(repitition)
Levator ani testing is used to quantify PFM strength
Time frame: 1 day
Pelvic floor muscle contraction endurance
muscle contractions maintained for 0 s are defined as grade 0,and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s. The endurance is measured by PHENIX instrument.
Time frame: 3 days
pelvic organ prolapse quantification(POP-Q)
POP-Q is measured when maximum valsalva
Time frame: 1 day
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