NCT03511911

The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pelvic Floor Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	evaluation of pelvic floor muscle function through the PHENIX instrument	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.
DIAGNOSTIC_TEST	vaginal palpation	vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

Timeline

• Start date: 2018-06-11
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-04-30
• Last updated: 2018-09-12

Locations

1 site across 1 country: China