Pelvic Floor DysfunctionNCT03511911
The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study
A study testing evaluation of pelvic floor muscle function through the PHENIX instrument and vaginal palpation in people with Pelvic Floor Dysfunction, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction
- What is being tested?
- evaluation of pelvic floor muscle function through the PHENIX instrument and vaginal palpation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2018to 31 Dec 2020
- Phase
- Interventional
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having sex life and tolerable to vaginal examination
- Planning to live locally for a long time
- Volunteers are divided into three groups Group A: healthy women
- healthy women for physical examination
- except in the first year after delivery,duration of lactation or with a clear diagnosis as pelvic organ prolapse beyond the level of hymen or incontinence.
- Group B:patients with pelvic floor disorders
Show all 10Show fewer
- patients diagnosed as incontinence by clinical presentation(patients with urinary incontinence are required to complete the questionnaire of ICIQ-SF)
- patients with pelvic organ prolapse beyond the level of hymen
- except in the first year after delivery,duration of lactation and patients with chronic pelvic pain
- Group C: female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval)
Who cannot join
- Patients who are undergoing pelvic floor muscle training
- History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
- History of pelvic radiotherapy
- History of pelvic floor surgery
- Duration of pregnancy
- Latex allergy
- Colpitis
- Operation on pelvis within 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, 100730
Zhijing Sun, MD, 13651314354, sunzhj2001@sina.com
About this study
- 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;
- To determine the intra- and inter-rater reliability of PFM strength measured using manometry in PHENIX instrument.
Read the 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
- Being tested
- evaluation of pelvic floor muscle function through the PHENIX instrument, vaginal palpation
- Keywords
- Pelvic floor muscle strength, modified Oxford Grading Scale, Levator ani testing, vaginal contraction pressure, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic test
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.
vaginal palpationDiagnostic test
vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength
| Study group | Role | What they receive |
|---|---|---|
| GROUP A1 | Experimental | In GROUP A1, participants are all healthy women.A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the participant her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,participants in group A1 will be tested by inspector B twice in the same way as what they have done the first day. Receives: Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument; Diagnostic Test: vaginal palpation |
| GROUP A2 | Experimental | In GROUP A2,participants are all healthy women.A gynecological physician evaluates participant's pelvic floor muscle strength by vaginal palpation without telling the participant her result, and records it on a unique paper other than in the Case Report Form as what GROUP A1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,participants in group A2 will be tested by inspector A twice in the same way as what they have done the first day. Receives: Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument; Diagnostic Test: vaginal palpation |
| GROUP B1 | Experimental | In GROUP B1,patients are all with pelvic floor disorders.A gynecological physician evaluates the patient's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the patient her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,patients in group B1 will be tested by inspector B twice in the same way as what they have done the first day. Receives: Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument; Diagnostic Test: vaginal palpation |
| GROUP B2 | Experimental | In GROUP B2,patients are all with pelvic floor disorders.A gynecological physician evaluates the patient's pelvic floor muscle strength by vaginal palpation without telling patient her result, and records it on a unique paper other than in the Case Report Form as what GROUP B1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,patients in group B2 will be tested by inspector A twice in the same way as what they have done the first day. Receives: Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument; Diagnostic Test: vaginal palpation |
| GROUP C1 | Experimental | In GROUP C1,participants are all female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval).A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the participant her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,participants in group C1 will be tested by inspector B twice in the same way as what they have done the first day. Receives: Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument; Diagnostic Test: vaginal palpation |
| GROUP C2 | Experimental | In GROUP C2,participants are all female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval).A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation without telling patient her result, and records it on a unique paper other than in the Case Report Form as what GROUP C1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,participants in group C2 will be tested by inspector A twice in the same way as what they have done the first day. Receives: Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument; Diagnostic Test: vaginal palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum vaginal contraction pressure
Maximum vaginal contraction pressure is evaluated by manometry
Measured: 3 days
Secondary outcomes (5)
vaginal rest pressure
measure when no vaginal contraction by manometry
Measured: 3 days
Pelvic floor muscle strength
The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation
Measured: 1 day
Pelvic floor muscle strength（repitition）
Levator ani testing is used to quantify PFM strength
Measured: 1 day
Pelvic floor muscle contraction endurance
muscle contractions maintained for 0 s are defined as grade 0,and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s. The endurance is measured by PHENIX instrument.
Measured: 3 days
pelvic organ prolapse quantification(POP-Q)
POP-Q is measured when maximum valsalva
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start11 Jun 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511911
- Sponsor's protocol ID
- JS-1548
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study
- ClinicalTrials.gov ID
- NCT03511911
- Acronym / sponsor ID
- JS-1548
- Conditions
- Pelvic Floor Dysfunction
- Keywords
- Pelvic floor muscle strength, modified Oxford Grading Scale, Levator ani testing, vaginal contraction pressure, reliability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Apr 2018 (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.
- 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;
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GROUP A1 | Experimental | Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument, Diagnostic Test: vaginal palpationIn GROUP A1, participants are all healthy women.A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the participant her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,participants in group A1 will be tested by inspector B twice in the same way as what they have done the first day. |
| GROUP A2 | Experimental | Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument, Diagnostic Test: vaginal palpationIn GROUP A2,participants are all healthy women.A gynecological physician evaluates participant's pelvic floor muscle strength by vaginal palpation without telling the participant her result, and records it on a unique paper other than in the Case Report Form as what GROUP A1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,participants in group A2 will be tested by inspector A twice in the same way as what they have done the first day. |
| GROUP B1 | Experimental | Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument, Diagnostic Test: vaginal palpationIn GROUP B1,patients are all with pelvic floor disorders.A gynecological physician evaluates the patient's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the patient her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,patients in group B1 will be tested by inspector B twice in the same way as what they have done the first day. |
| GROUP B2 | Experimental | Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument, Diagnostic Test: vaginal palpationIn GROUP B2,patients are all with pelvic floor disorders.A gynecological physician evaluates the patient's pelvic floor muscle strength by vaginal palpation without telling patient her result, and records it on a unique paper other than in the Case Report Form as what GROUP B1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,patients in group B2 will be tested by inspector A twice in the same way as what they have done the first day. |
| GROUP C1 | Experimental | Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument, Diagnostic Test: vaginal palpationIn GROUP C1,participants are all female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval).A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the participant her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,participants in group C1 will be tested by inspector B twice in the same way as what they have done the first day. |
| GROUP C2 | Experimental | Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument, Diagnostic Test: vaginal palpationIn GROUP C2,participants are all female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval).A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation without telling patient her result, and records it on a unique paper other than in the Case Report Form as what GROUP C1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,participants in group C2 will be tested by inspector A twice in the same way as what they have done the first day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Having sex life and tolerable to vaginal examination
- Planning to live locally for a long time
- Volunteers are divided into three groups Group A: healthy women
- healthy women for physical examination
- except in the first year after delivery,duration of lactation or with a clear diagnosis as pelvic organ prolapse beyond the level of hymen or incontinence.
Key exclusion criteria (8 listed)
- Patients who are undergoing pelvic floor muscle training
- History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
- History of pelvic radiotherapy
- History of pelvic floor surgery
- Duration of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of pelvic floor muscle function through the PHENIX instrumentthe 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 | GROUP A1, GROUP A2, GROUP B1, GROUP B2, GROUP C1, GROUP C2 |
| vaginal palpationvaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength | Diagnostic test | GROUP A1, GROUP A2, GROUP B1, GROUP B2, GROUP C1, GROUP C2 |
Primary outcome
Maximum vaginal contraction pressure
Time frame: 3 days
Maximum vaginal contraction pressure is evaluated by manometry
5 secondary outcomes
vaginal rest pressure
Time frame: 3 days
Pelvic floor muscle strength
Time frame: 1 day
Pelvic floor muscle strength（repitition）
Time frame: 1 day
Pelvic floor muscle contraction endurance
Time frame: 3 days
pelvic organ prolapse quantification(POP-Q)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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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.
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of pelvic floor muscle function through the PHENIX instrument and vaginal palpation in people with Pelvic Floor Dysfunction, run by Peking Union Medical College Hospital at 1 site in China.
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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijing Sun, MD (13651314354, sunzhj2001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum vaginal contraction pressure (time frame: 3 days). 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 12 Sep 2018.