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

NCT03511911 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2018-09-12

No results posted yet for this study

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.

Conditions

  • Pelvic Floor Dysfunction

Interventions

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Lan Zhu, MD · Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511911 on ClinicalTrials.gov