- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04482426
Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function (PFMF)
Study Overview
Status
Conditions
Detailed Description
Female pelvic floor disorders including sexual dysfunction, urinary incontinence, fecal incontinence, and pelvic organ prolapse are relating to the function of pelvic floor structures. Essential components responsible for pelvic floor function include bony, muscular, and fascial structures of the pelvis. Among above components, pelvic floor muscles, either the superficial or deep group, are considered crucial in maintaining the morphology and functional integrity of the pelvic floor.
Inspection and digital examination incorporating Oxford grading system during pelvic examinations are the most convenient and commonly methods applied to evaluate the function of pelvic floor muscles. Nevertheless, both methods cannot provide quantitative information of pelvic floor muscle contraction. With the introduction of pelvic floor manometry and electrophysiological testing, quantification of pelvic floor muscle contractions can be expected.
The study aimed to explore and quantify functional and electrical activities in different pelvic floor muscle groups, to differentiate the electrophysiological role in different pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to develop treatment strategies for different pelvic floor muscle groups in different female pelvic disorders.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women with pelvic floor dysfuntion
Exclusion Criteria:
- Pregnant women
- Women with histories of diabetes, cerebrovascular diseases, neurological diseases, degenerative muscular diseases, or autoimmune connective tissue diseases。
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contraction of pelvic floor muscle
Time Frame: Baseline
|
Chart review
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CGH-P102071
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