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Trial record 9 of 91 for:    Recruiting, Not yet recruiting, Available Studies | "Pelvic Floor"

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

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ClinicalTrials.gov Identifier: NCT03511911
Recruitment Status : Not yet recruiting
First Posted : April 30, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Dysfunction Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument Diagnostic Test: vaginal palpation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: GROUP A1
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.
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

Experimental: GROUP A2
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.
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

Experimental: GROUP B1
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.
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

Experimental: GROUP B2
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.
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

Experimental: GROUP C1
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.
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

Experimental: GROUP C2
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.
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




Primary Outcome Measures :
  1. Maximum vaginal contraction pressure [ Time Frame: 3 days ]
    Maximum vaginal contraction pressure is evaluated by manometry


Secondary Outcome Measures :
  1. vaginal rest pressure [ Time Frame: 3 days ]
    measure when no vaginal contraction by manometry

  2. Pelvic floor muscle strength [ Time Frame: 1 day ]
    The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation

  3. Pelvic floor muscle strength(repitition) [ Time Frame: 1 day ]
    Levator ani testing is used to quantify PFM strength

  4. Pelvic floor muscle contraction endurance [ Time Frame: 3 days ]
    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.

  5. pelvic organ prolapse quantification(POP-Q) [ Time Frame: 1 day ]
    POP-Q is measured when maximum valsalva



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Having sex life and tolerable to vaginal examination
  2. Planning to live locally for a long time

Volunteers are divided into three groups Group A: healthy women

  1. healthy women for physical examination
  2. 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

  1. patients diagnosed as incontinence by clinical presentation(patients with urinary incontinence are required to complete the questionnaire of ICIQ-SF)
  2. patients with pelvic organ prolapse beyond the level of hymen
  3. 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)

Exclusion Criteria:

  1. Patients who are undergoing pelvic floor muscle training
  2. History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect)
  3. History of pelvic radiotherapy
  4. History of pelvic floor surgery
  5. Duration of pregnancy
  6. Latex allergy
  7. Colpitis
  8. Operation on pelvis within 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511911


Contacts
Contact: Zhijing Sun, MD 13651314354 sunzhj2001@sina.com
Contact: Lan Zhu, MD 13911714696 zhu_julie@vip.sina.com

Locations
China, Beiing
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences Not yet recruiting
Beijing, Beiing, China, 100730
Contact: Zhijing Sun, MD    13651314354    sunzhj2001@sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu, MD Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03511911     History of Changes
Other Study ID Numbers: JS-1548
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:
Pelvic floor muscle strength
modified Oxford Grading Scale
Levator ani testing
vaginal contraction pressure
reliability