Pelvic FloorPFMFNCT04482426
Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function
An observational study of Pelvic Floor, run by Cathay General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pelvic Floor
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2014to 11 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with pelvic floor dysfunction
Who may be able to join
- Women with pelvic floor dysfuntion
Who cannot join
- Pregnant women
- Women with histories of diabetes, cerebrovascular diseases, neurological diseases, degenerative muscular diseases, or autoimmune connective tissue diseases。
About this study
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.
Read the 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.
- Conditions
- Pelvic Floor
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraction of pelvic floor muscle
Chart review
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start25 Jul 2014
- Primary completion29 Aug 2015
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FloorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Chen Huang, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482426
- Sponsor's protocol ID
- CGH-P102071
- Acronym
- PFMF
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function
- ClinicalTrials.gov ID
- NCT04482426
- Acronym / sponsor ID
- PFMF / CGH-P102071
- Conditions
- Pelvic Floor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- 25 Jul 2014
- Primary completion
- 29 Aug 2015 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with pelvic floor dysfunction
Key inclusion criteria (1 listed)
- Women with pelvic floor dysfuntion
Key exclusion criteria (2 listed)
- Pregnant women
- Women with histories of diabetes, cerebrovascular diseases, neurological diseases, degenerative muscular diseases, or autoimmune connective tissue diseases。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contraction of pelvic floor muscle
Time frame: Baseline
Chart review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Related trials for Pelvic Floor
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor, run by Cathay General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraction of pelvic floor muscle (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.