Pelvic Floor Dysfunction Clinical Trial
Official title:
The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study
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.
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