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PFMF: Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function

Sponsor
Cathay General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04482426
Collaborator
(none)
112
Enrollment
36.6
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    112 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function
    Study Start Date :
    Jul 25, 2014
    Actual Primary Completion Date :
    Aug 29, 2015
    Actual Study Completion Date :
    Aug 11, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Contraction of pelvic floor muscle [Baseline]

      Chart review

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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。

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cathay General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wen-Chen Huang, Professor, Cathay General Hospital
    ClinicalTrials.gov Identifier:
    NCT04482426
    Other Study ID Numbers:
    • CGH-P102071
    First Posted:
    Jul 22, 2020
    Last Update Posted:
    Jul 22, 2020
    Last Verified:
    Jul 1, 2020

    Study Results

    No Results Posted as of Jul 22, 2020